COVID-19 Updates

“There are decades where nothing happens,” wrote Vladimir Lenin, “and there are weeks where decades happen.” Barely a dozen weeks ago, no one knew that the SARS-CoV-2 virus existed. Now, it has spread to almost every country on Earth, infecting over 1.8 million people whom we know about, and many more whom we do not. In so doing, it has crashed economies and health care systems, filled hospitals, emptied public spaces, and separated people from their workplaces and their friends on a scale that few of us have ever witnessed.

It has also triggered an avalanche of questions as to why our initial response was so thoroughly lethargic, rudderless, and uncoordinated; while there is plenty of blame to go around, that is for another time. The glaring question for many – including physicians trying to keep our private practices viable – is: What now?

The answer depends, of course, on how the pandemic plays out. No one yet knows exactly what will happen, but much depends on two properties of the virus, both of which are currently unknown. First: seasonality. Coronaviruses tend to thrive in winter and wane in the summer. That may also be true for SARS-CoV-2, but seasonal variations might not sufficiently slow the virus when it has so many immunologically naive hosts to infect. As I write this in mid-April, we wait anxiously to see what – if anything – summer temperatures do to its transmission in the Northern Hemisphere.

The second wild card is duration of immunity. Determining that will involve developing accurate serologic tests and administering them widely. Immune citizens, once identified, can return to work, care for the vulnerable, and anchor the economy during future outbreaks.

Even if we do get a summer hiatus, seasonal viruses typically return as winter approaches. We could conceivably still be mopping up from this outbreak when the virus – if it is seasonal – comes roaring back in October or November. Will we be ready? Or will it catch us with our pants amidships yet again?

I can envision two possibilities: Assuming we luck into a seasonal reprieve in the next few weeks, infection rates should drop, which could allow our private practices to return toward some semblance of normal – if health workers and patients alike can be convinced that our offices and clinics are safe. This might be accomplished as part of our overall preparation for a potential winter recurrence, by checking every patient’s temperature at the waiting room door. Similarly, all students should get a daily temperature check at school, as should all commuters, airline passengers, and individuals at any sizable gathering. Every fever should trigger a COVID-19 test, and every positive test should launch aggressive contact tracing and quarantines. Meanwhile, treatments and vaccines should get fast-tracked.

That’s what should happen. If it doesn’t, and COVID-19 recurs next winter, worse than before, it is anybody’s guess whether most private medical practices will be able to weather a second onslaught. Further government funding is not assured. We won’t have a vaccine by November. Chloroquine, hydroxychloroquine, and azithromycin might turn out to be helpful, but we can’t count on them.

Even if we do get lucky with seasonality, the question remains of how long it will take to restore public confidence and reboot the economy. Economies generally do not function like light switches that can be turned off for a while then simply turned back on, but act more like campfires. If you pour a bucket of water on one, it takes some time to get it cranked up again. After the “Great Recession” of 2008, it took nearly 10 years.

So now, with great reluctance, I must trot out a hoary old cliché: Hope for the best, but plan for the worst. Everyone’s situation will be different, of course, but I can make a few general suggestions. Perform a difficult mental exercise: What will you do if SARS-CoV-2 outlasts emergency funds from the Paycheck Protection and Economic Injury Disaster programs? Do the math – how long can you keep your practice afloat without floating further loans or dipping into personal savings? If you don’t know how many patients you need to see per day to break even, figure it out – now. On what day will you run out of money? When will you start putting your future at risk?

None of us thought we would ever have to face questions like these, of course – and how ironic is it that a medical emergency has forced them upon us? I sincerely hope that none of us will need to actually confront this Hobson’s choice in the coming months, but far better to address the hypothetical now than the reality later. As always, consult with your own attorney, accountant, and other business advisors before making any life-altering decisions.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com. He has no disclosures.

“There are decades where nothing happens,” wrote Vladimir Lenin, “and there are weeks where decades happen.” Barely a dozen weeks ago, no one knew that the SARS-CoV-2 virus existed. Now, it has spread to almost every country on Earth, infecting over 1.8 million people whom we know about, and many more whom we do not. In so doing, it has crashed economies and health care systems, filled hospitals, emptied public spaces, and separated people from their workplaces and their friends on a scale that few of us have ever witnessed.

It has also triggered an avalanche of questions as to why our initial response was so thoroughly lethargic, rudderless, and uncoordinated; while there is plenty of blame to go around, that is for another time. The glaring question for many – including physicians trying to keep our private practices viable – is: What now?

The answer depends, of course, on how the pandemic plays out. No one yet knows exactly what will happen, but much depends on two properties of the virus, both of which are currently unknown. First: seasonality. Coronaviruses tend to thrive in winter and wane in the summer. That may also be true for SARS-CoV-2, but seasonal variations might not sufficiently slow the virus when it has so many immunologically naive hosts to infect. As I write this in mid-April, we wait anxiously to see what – if anything – summer temperatures do to its transmission in the Northern Hemisphere.

The second wild card is duration of immunity. Determining that will involve developing accurate serologic tests and administering them widely. Immune citizens, once identified, can return to work, care for the vulnerable, and anchor the economy during future outbreaks.

Even if we do get a summer hiatus, seasonal viruses typically return as winter approaches. We could conceivably still be mopping up from this outbreak when the virus – if it is seasonal – comes roaring back in October or November. Will we be ready? Or will it catch us with our pants amidships yet again?

I can envision two possibilities: Assuming we luck into a seasonal reprieve in the next few weeks, infection rates should drop, which could allow our private practices to return toward some semblance of normal – if health workers and patients alike can be convinced that our offices and clinics are safe. This might be accomplished as part of our overall preparation for a potential winter recurrence, by checking every patient’s temperature at the waiting room door. Similarly, all students should get a daily temperature check at school, as should all commuters, airline passengers, and individuals at any sizable gathering. Every fever should trigger a COVID-19 test, and every positive test should launch aggressive contact tracing and quarantines. Meanwhile, treatments and vaccines should get fast-tracked.

That’s what should happen. If it doesn’t, and COVID-19 recurs next winter, worse than before, it is anybody’s guess whether most private medical practices will be able to weather a second onslaught. Further government funding is not assured. We won’t have a vaccine by November. Chloroquine, hydroxychloroquine, and azithromycin might turn out to be helpful, but we can’t count on them.

Even if we do get lucky with seasonality, the question remains of how long it will take to restore public confidence and reboot the economy. Economies generally do not function like light switches that can be turned off for a while then simply turned back on, but act more like campfires. If you pour a bucket of water on one, it takes some time to get it cranked up again. After the “Great Recession” of 2008, it took nearly 10 years.

So now, with great reluctance, I must trot out a hoary old cliché: Hope for the best, but plan for the worst. Everyone’s situation will be different, of course, but I can make a few general suggestions. Perform a difficult mental exercise: What will you do if SARS-CoV-2 outlasts emergency funds from the Paycheck Protection and Economic Injury Disaster programs? Do the math – how long can you keep your practice afloat without floating further loans or dipping into personal savings? If you don’t know how many patients you need to see per day to break even, figure it out – now. On what day will you run out of money? When will you start putting your future at risk?

None of us thought we would ever have to face questions like these, of course – and how ironic is it that a medical emergency has forced them upon us? I sincerely hope that none of us will need to actually confront this Hobson’s choice in the coming months, but far better to address the hypothetical now than the reality later. As always, consult with your own attorney, accountant, and other business advisors before making any life-altering decisions.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com. He has no disclosures.

“There are decades where nothing happens,” wrote Vladimir Lenin, “and there are weeks where decades happen.” Barely a dozen weeks ago, no one knew that the SARS-CoV-2 virus existed. Now, it has spread to almost every country on Earth, infecting over 1.8 million people whom we know about, and many more whom we do not. In so doing, it has crashed economies and health care systems, filled hospitals, emptied public spaces, and separated people from their workplaces and their friends on a scale that few of us have ever witnessed.

It has also triggered an avalanche of questions as to why our initial response was so thoroughly lethargic, rudderless, and uncoordinated; while there is plenty of blame to go around, that is for another time. The glaring question for many – including physicians trying to keep our private practices viable – is: What now?

The answer depends, of course, on how the pandemic plays out. No one yet knows exactly what will happen, but much depends on two properties of the virus, both of which are currently unknown. First: seasonality. Coronaviruses tend to thrive in winter and wane in the summer. That may also be true for SARS-CoV-2, but seasonal variations might not sufficiently slow the virus when it has so many immunologically naive hosts to infect. As I write this in mid-April, we wait anxiously to see what – if anything – summer temperatures do to its transmission in the Northern Hemisphere.

The second wild card is duration of immunity. Determining that will involve developing accurate serologic tests and administering them widely. Immune citizens, once identified, can return to work, care for the vulnerable, and anchor the economy during future outbreaks.

Even if we do get a summer hiatus, seasonal viruses typically return as winter approaches. We could conceivably still be mopping up from this outbreak when the virus – if it is seasonal – comes roaring back in October or November. Will we be ready? Or will it catch us with our pants amidships yet again?

I can envision two possibilities: Assuming we luck into a seasonal reprieve in the next few weeks, infection rates should drop, which could allow our private practices to return toward some semblance of normal – if health workers and patients alike can be convinced that our offices and clinics are safe. This might be accomplished as part of our overall preparation for a potential winter recurrence, by checking every patient’s temperature at the waiting room door. Similarly, all students should get a daily temperature check at school, as should all commuters, airline passengers, and individuals at any sizable gathering. Every fever should trigger a COVID-19 test, and every positive test should launch aggressive contact tracing and quarantines. Meanwhile, treatments and vaccines should get fast-tracked.

That’s what should happen. If it doesn’t, and COVID-19 recurs next winter, worse than before, it is anybody’s guess whether most private medical practices will be able to weather a second onslaught. Further government funding is not assured. We won’t have a vaccine by November. Chloroquine, hydroxychloroquine, and azithromycin might turn out to be helpful, but we can’t count on them.

Even if we do get lucky with seasonality, the question remains of how long it will take to restore public confidence and reboot the economy. Economies generally do not function like light switches that can be turned off for a while then simply turned back on, but act more like campfires. If you pour a bucket of water on one, it takes some time to get it cranked up again. After the “Great Recession” of 2008, it took nearly 10 years.

So now, with great reluctance, I must trot out a hoary old cliché: Hope for the best, but plan for the worst. Everyone’s situation will be different, of course, but I can make a few general suggestions. Perform a difficult mental exercise: What will you do if SARS-CoV-2 outlasts emergency funds from the Paycheck Protection and Economic Injury Disaster programs? Do the math – how long can you keep your practice afloat without floating further loans or dipping into personal savings? If you don’t know how many patients you need to see per day to break even, figure it out – now. On what day will you run out of money? When will you start putting your future at risk?

None of us thought we would ever have to face questions like these, of course – and how ironic is it that a medical emergency has forced them upon us? I sincerely hope that none of us will need to actually confront this Hobson’s choice in the coming months, but far better to address the hypothetical now than the reality later. As always, consult with your own attorney, accountant, and other business advisors before making any life-altering decisions.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com. He has no disclosures.

As the COVID-19 pandemic continues, minimizing risks of infection to patients with cancer while maintaining good outcomes remains a priority. An international panel of experts has now issued recommendations for treating patients with rectal cancer, which includes using a short pre-operative course of radiotherapy (SCRT) and then delaying surgery.

Using SCRT translates to fewer hospital appointments, which will keep patients safer and allow them to maintain social distancing. The panel also found that surgery can be safely delayed by up to 12 weeks, and thus will allow procedures to be rescheduled after the pandemic peaks.

“The COVID-19 pandemic is a global emergency and we needed to work very quickly to identify changes that would benefit patients,” said David Sebag-Montefiore, MD, a professor of clinical oncology at the University of Leeds and honorary clinical oncologist with the Leeds Teaching Hospitals NHS Trust, who led the 15 member panel. “Our recommendations were published 20 days after our first meeting.”

“This process normally takes many months, if not years,” he said in a statement.

The recommendations were published online April 2 in Radiotherapy and Oncology.

The panel used the European Society for Medical Oncology (ESMO) rectal cancer guidelines as a framework to describe these new recommendations.

Recommendations by Stage

The recommendations were categorized into four subgroups based on cancer stage.

Early stage

• The ESMO guidelines recommend total mesorectal excision (TME) surgery without pre-operative radiotherapy for most cases.
• Panel recommendation also strongly supports the use of TME without pre-operative radiotherapy.

Intermediate stage

• The ESMO guidelines recommend TME alone or combined with SCRT or conventional radiotherapy (CRT) if there is uncertainty that a good quality mesorectal excision can be achieved.
• The panel strongly recommends TME alone in regions where high quality surgery is performed. The use of radiotherapy in this subgroup requires careful discussion, as the benefits of preoperative radiotherapy are likely to be small. If radiotherapy is used, then the preferred option should be SCRT.

Locally advanced

• The ESMO guideline recommends either pre-operative SCRT or CRT.
• The panel strongly recommends the use of SCRT and notes two phase 3 trials have compared SCRT and CRT and showed comparable outcomes for local recurrence, disease-free survival, overall survival, and late toxicity. In the COVID-19 setting, the panel points out that SCRT has many advantages over CRT, namely that there is less acute toxicity, fewer treatments which translate to less travel and contact with other patients and staff, and a significantly reduced risk of COVID-19 infection during treatment.

Timing of surgery after SCRT

• The ESMO guideline does not have any recommendations as they were issued before the Stockholm III trial (Lancet Oncol. 2017;18:336-46).
• The panel notes that the use of SCRT and delaying surgery has advantages that can be beneficial in both routine clinical practice and the COVID-19 setting. Several clinical trials have recommended that surgery should be performed within 3-7 days of completing radiotherapy, but the Stockholm III trial reported no difference in outcomes when surgery was delayed. It compared surgery performed within 1 week versus 4-8 weeks following SCRT and there was no difference in any survival endpoints. In addition, a longer delay to surgery was associated with a reduction in post-operative and surgical morbidity although no differences in severe complications or re-operations.

Advanced subgroup

• The ESMO guidelines recommend the use of pre-operative CRT or SCRT followed by neoadjuvant chemotherapy. CRT should be given as a fluoropyrimidine (usually capecitabine) combined with radiotherapy of 45-50.4 Gy over 5-5.5 weeks. Adjuvant chemotherapy should be considered but there is wide international variation in its use.
• The panel recommends that two options be considered based on the current evidence. The first is pre-op CRT, which is the most established standard of care, with the duration of concurrent capecitabine chemotherapy limited to 5-5.5 weeks. The second option is SCRT with or without neoadjuvant chemotherapy. In this case, the duration of radiotherapy is substantially less and has advantages versus CRT. “We consider both options to be acceptable but note the advantages of using SCRT in the COVID-19 setting,” the authors write. “The decision to use neoadjuvant chemotherapy in option 2 will reflect the attitudes to neoadjuvant and adjuvant chemotherapy in each country, the assessment of the risk-benefit ratio, considering the risk factors for COVID-19 increased mortality, and the capacity and prioritization of chemotherapy delivery.”

Organ Preservation

Organ preservation is being increasingly considered when a complete clinical response is achieved after CRT or SCRT, the panel points out. “An organ preservation approach may be considered during the COVID-19 period providing that resources for an adequate surveillance including imaging and endoscopy are available to detect local failures that require salvage surgery,” they write.

This article first appeared on Medscape.com.

As the COVID-19 pandemic continues, minimizing risks of infection to patients with cancer while maintaining good outcomes remains a priority. An international panel of experts has now issued recommendations for treating patients with rectal cancer, which includes using a short pre-operative course of radiotherapy (SCRT) and then delaying surgery.

Using SCRT translates to fewer hospital appointments, which will keep patients safer and allow them to maintain social distancing. The panel also found that surgery can be safely delayed by up to 12 weeks, and thus will allow procedures to be rescheduled after the pandemic peaks.

“The COVID-19 pandemic is a global emergency and we needed to work very quickly to identify changes that would benefit patients,” said David Sebag-Montefiore, MD, a professor of clinical oncology at the University of Leeds and honorary clinical oncologist with the Leeds Teaching Hospitals NHS Trust, who led the 15 member panel. “Our recommendations were published 20 days after our first meeting.”

“This process normally takes many months, if not years,” he said in a statement.

The recommendations were published online April 2 in Radiotherapy and Oncology.

The panel used the European Society for Medical Oncology (ESMO) rectal cancer guidelines as a framework to describe these new recommendations.

Recommendations by Stage

The recommendations were categorized into four subgroups based on cancer stage.

Early stage

• The ESMO guidelines recommend total mesorectal excision (TME) surgery without pre-operative radiotherapy for most cases.
• Panel recommendation also strongly supports the use of TME without pre-operative radiotherapy.

Intermediate stage

• The ESMO guidelines recommend TME alone or combined with SCRT or conventional radiotherapy (CRT) if there is uncertainty that a good quality mesorectal excision can be achieved.
• The panel strongly recommends TME alone in regions where high quality surgery is performed. The use of radiotherapy in this subgroup requires careful discussion, as the benefits of preoperative radiotherapy are likely to be small. If radiotherapy is used, then the preferred option should be SCRT.

Locally advanced

• The ESMO guideline recommends either pre-operative SCRT or CRT.
• The panel strongly recommends the use of SCRT and notes two phase 3 trials have compared SCRT and CRT and showed comparable outcomes for local recurrence, disease-free survival, overall survival, and late toxicity. In the COVID-19 setting, the panel points out that SCRT has many advantages over CRT, namely that there is less acute toxicity, fewer treatments which translate to less travel and contact with other patients and staff, and a significantly reduced risk of COVID-19 infection during treatment.

Timing of surgery after SCRT

• The ESMO guideline does not have any recommendations as they were issued before the Stockholm III trial (Lancet Oncol. 2017;18:336-46).
• The panel notes that the use of SCRT and delaying surgery has advantages that can be beneficial in both routine clinical practice and the COVID-19 setting. Several clinical trials have recommended that surgery should be performed within 3-7 days of completing radiotherapy, but the Stockholm III trial reported no difference in outcomes when surgery was delayed. It compared surgery performed within 1 week versus 4-8 weeks following SCRT and there was no difference in any survival endpoints. In addition, a longer delay to surgery was associated with a reduction in post-operative and surgical morbidity although no differences in severe complications or re-operations.

Advanced subgroup

• The ESMO guidelines recommend the use of pre-operative CRT or SCRT followed by neoadjuvant chemotherapy. CRT should be given as a fluoropyrimidine (usually capecitabine) combined with radiotherapy of 45-50.4 Gy over 5-5.5 weeks. Adjuvant chemotherapy should be considered but there is wide international variation in its use.
• The panel recommends that two options be considered based on the current evidence. The first is pre-op CRT, which is the most established standard of care, with the duration of concurrent capecitabine chemotherapy limited to 5-5.5 weeks. The second option is SCRT with or without neoadjuvant chemotherapy. In this case, the duration of radiotherapy is substantially less and has advantages versus CRT. “We consider both options to be acceptable but note the advantages of using SCRT in the COVID-19 setting,” the authors write. “The decision to use neoadjuvant chemotherapy in option 2 will reflect the attitudes to neoadjuvant and adjuvant chemotherapy in each country, the assessment of the risk-benefit ratio, considering the risk factors for COVID-19 increased mortality, and the capacity and prioritization of chemotherapy delivery.”

Organ Preservation

Organ preservation is being increasingly considered when a complete clinical response is achieved after CRT or SCRT, the panel points out. “An organ preservation approach may be considered during the COVID-19 period providing that resources for an adequate surveillance including imaging and endoscopy are available to detect local failures that require salvage surgery,” they write.

This article first appeared on Medscape.com.

As the COVID-19 pandemic continues, minimizing risks of infection to patients with cancer while maintaining good outcomes remains a priority. An international panel of experts has now issued recommendations for treating patients with rectal cancer, which includes using a short pre-operative course of radiotherapy (SCRT) and then delaying surgery.

Using SCRT translates to fewer hospital appointments, which will keep patients safer and allow them to maintain social distancing. The panel also found that surgery can be safely delayed by up to 12 weeks, and thus will allow procedures to be rescheduled after the pandemic peaks.

“The COVID-19 pandemic is a global emergency and we needed to work very quickly to identify changes that would benefit patients,” said David Sebag-Montefiore, MD, a professor of clinical oncology at the University of Leeds and honorary clinical oncologist with the Leeds Teaching Hospitals NHS Trust, who led the 15 member panel. “Our recommendations were published 20 days after our first meeting.”

“This process normally takes many months, if not years,” he said in a statement.

The recommendations were published online April 2 in Radiotherapy and Oncology.

The panel used the European Society for Medical Oncology (ESMO) rectal cancer guidelines as a framework to describe these new recommendations.

Recommendations by Stage

The recommendations were categorized into four subgroups based on cancer stage.

Early stage

• The ESMO guidelines recommend total mesorectal excision (TME) surgery without pre-operative radiotherapy for most cases.
• Panel recommendation also strongly supports the use of TME without pre-operative radiotherapy.

Intermediate stage

• The ESMO guidelines recommend TME alone or combined with SCRT or conventional radiotherapy (CRT) if there is uncertainty that a good quality mesorectal excision can be achieved.
• The panel strongly recommends TME alone in regions where high quality surgery is performed. The use of radiotherapy in this subgroup requires careful discussion, as the benefits of preoperative radiotherapy are likely to be small. If radiotherapy is used, then the preferred option should be SCRT.

Locally advanced

• The ESMO guideline recommends either pre-operative SCRT or CRT.
• The panel strongly recommends the use of SCRT and notes two phase 3 trials have compared SCRT and CRT and showed comparable outcomes for local recurrence, disease-free survival, overall survival, and late toxicity. In the COVID-19 setting, the panel points out that SCRT has many advantages over CRT, namely that there is less acute toxicity, fewer treatments which translate to less travel and contact with other patients and staff, and a significantly reduced risk of COVID-19 infection during treatment.

Timing of surgery after SCRT

• The ESMO guideline does not have any recommendations as they were issued before the Stockholm III trial (Lancet Oncol. 2017;18:336-46).
• The panel notes that the use of SCRT and delaying surgery has advantages that can be beneficial in both routine clinical practice and the COVID-19 setting. Several clinical trials have recommended that surgery should be performed within 3-7 days of completing radiotherapy, but the Stockholm III trial reported no difference in outcomes when surgery was delayed. It compared surgery performed within 1 week versus 4-8 weeks following SCRT and there was no difference in any survival endpoints. In addition, a longer delay to surgery was associated with a reduction in post-operative and surgical morbidity although no differences in severe complications or re-operations.

Advanced subgroup

• The ESMO guidelines recommend the use of pre-operative CRT or SCRT followed by neoadjuvant chemotherapy. CRT should be given as a fluoropyrimidine (usually capecitabine) combined with radiotherapy of 45-50.4 Gy over 5-5.5 weeks. Adjuvant chemotherapy should be considered but there is wide international variation in its use.
• The panel recommends that two options be considered based on the current evidence. The first is pre-op CRT, which is the most established standard of care, with the duration of concurrent capecitabine chemotherapy limited to 5-5.5 weeks. The second option is SCRT with or without neoadjuvant chemotherapy. In this case, the duration of radiotherapy is substantially less and has advantages versus CRT. “We consider both options to be acceptable but note the advantages of using SCRT in the COVID-19 setting,” the authors write. “The decision to use neoadjuvant chemotherapy in option 2 will reflect the attitudes to neoadjuvant and adjuvant chemotherapy in each country, the assessment of the risk-benefit ratio, considering the risk factors for COVID-19 increased mortality, and the capacity and prioritization of chemotherapy delivery.”

Organ Preservation

Organ preservation is being increasingly considered when a complete clinical response is achieved after CRT or SCRT, the panel points out. “An organ preservation approach may be considered during the COVID-19 period providing that resources for an adequate surveillance including imaging and endoscopy are available to detect local failures that require salvage surgery,” they write.

This article first appeared on Medscape.com.

Asymptomatic or presymptomatic for COVID-19? Experts with the Infectious Diseases Society of America (IDSA) discussed the shift in thinking between the two terms at a media briefing April 10.

They also addressed racial disparities surrounding COVID-19, and announced new IDSA guidelines for diagnosis and treatment of the illness.

Regarding the shifting thinking on symptoms and transmission of the novel coronavirus, when it comes to presymptomatic or asymptomatic, “pre” is really the right terminology, Carlos del Rio, MD, professor of medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, said during the briefing, because it’s not that people are asymptomatic but that they develop symptoms later and start transmitting the virus 24 to 48 hours before they develop symptoms.

“Clearly, this plays a role in transmission,” with some studies suggesting that 6% to 12% of transmissions occur during this presymptomatic stage, he explained.

Jeanne Marrazzo, MD, MPH, director of the Division of Infectious Diseases at University of Alabama at Birmingham, noted that early in the COVID-19 pandemic, the presymptomatic phase “could have been missed because we didn’t realize the wide ranging symptoms this disease has.”

This is turning out to be a “very interesting” virus with “fascinating” symptoms, she told reporters on the call.

The virus seems to have capacity to affect far more than just the respiratory tract. Initially, however, it was viewed “very much like a classic respiratory viral infection. As a result, a lot of people were refused testing because they were not showing the classic signs” of respiratory infection, Marrazzo noted.

It’s now clear that the range of symptoms is quite different, she said.

Notably, loss of smell seems to be “very characteristic and very specific to this infection. I can’t think of another common viral infection that causes loss of smell before you start to see other things,” Marrazzo said.

Data also suggest that gastrointestinal symptoms are common with COVID-19. Early data suggest that diarrhea probably occurs in about one third of patients. Some people have reported abdominal pain as the first sign, she said.

“Now that we know about the more wide range of symptoms associated [with COVID-19], we are being much more open to considering people perhaps having this infection. There is a lower index of suspicion and much lower threshold for diagnostic testing,” Marrazzo said, adding that there are still many barriers to testing and getting test results.

Stark Racial Disparities Need Greater Understanding

The second major topic of discussion at the briefing was the growing realization of racial disparities in COVID-19.

“Racial disparities in our country are not new but racial disparities in this disease are pretty stark,” del Rio said. “We live in a country where disparities have really colored a lot of what our diseases are, from HIV to diabetes to hypertension, and it’s not surprising that we are seeing this now with COVID-19.”

Marrazzo noted that, in Alabama, around 20% of the population is African American, yet almost 40% of COVID-19 deaths are occurring in this population. “The most stark statistics are coming out of Illinois and Michigan, where less than around 15% of the population is African American and yet 70% of the deaths are occurring in that group,” she said.

Both del Rio and Marrazzo agreed that understanding the racial differences in COVID-19 deaths is going to require a lot of analysis in the coming months.

Part of it likely reflects the challenge of social distancing in urban areas, Marrazzo said. “Social distancing is a luxury afforded by having a really big space, and space is money.”

The other long-standing challenge of unequal access to healthcare also likely plays a role, she said. This includes missing out on preventive health appointments and screenings, which can translate into more comorbidities, particularly hypertension.

The evolving evidence about the virus, and the stark conditions that frontline clinicians face, make this an especially challenging public health crisis, del Rio said.

“Taking care of these patients is incredibly taxing and my hat is off to physicians, residents, nurses, everybody working on this in the hospitals because they are really doing a yeoman’s work,” he said.

“These are not easy patients to take care of. Not only are [the frontline clinicians] providing care, they are caring for the patient and providing a comfort and someone to listen to when family can’t be present,” del Rio emphasized.

New Guidelines

The IDSA just released new guidelines for diagnosis and treatment of COVID-19.

“We are learning new things every day about this virus. Things are rapidly changing, and as we learn new things we have to adapt and make changes,” del Rio said.

del Rio noted that the guildelines “will evolve and change as more information comes out.”

This article first appeared on Medscape.com.

Asymptomatic or presymptomatic for COVID-19? Experts with the Infectious Diseases Society of America (IDSA) discussed the shift in thinking between the two terms at a media briefing April 10.

They also addressed racial disparities surrounding COVID-19, and announced new IDSA guidelines for diagnosis and treatment of the illness.

Regarding the shifting thinking on symptoms and transmission of the novel coronavirus, when it comes to presymptomatic or asymptomatic, “pre” is really the right terminology, Carlos del Rio, MD, professor of medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, said during the briefing, because it’s not that people are asymptomatic but that they develop symptoms later and start transmitting the virus 24 to 48 hours before they develop symptoms.

“Clearly, this plays a role in transmission,” with some studies suggesting that 6% to 12% of transmissions occur during this presymptomatic stage, he explained.

Jeanne Marrazzo, MD, MPH, director of the Division of Infectious Diseases at University of Alabama at Birmingham, noted that early in the COVID-19 pandemic, the presymptomatic phase “could have been missed because we didn’t realize the wide ranging symptoms this disease has.”

This is turning out to be a “very interesting” virus with “fascinating” symptoms, she told reporters on the call.

The virus seems to have capacity to affect far more than just the respiratory tract. Initially, however, it was viewed “very much like a classic respiratory viral infection. As a result, a lot of people were refused testing because they were not showing the classic signs” of respiratory infection, Marrazzo noted.

It’s now clear that the range of symptoms is quite different, she said.

Notably, loss of smell seems to be “very characteristic and very specific to this infection. I can’t think of another common viral infection that causes loss of smell before you start to see other things,” Marrazzo said.

Data also suggest that gastrointestinal symptoms are common with COVID-19. Early data suggest that diarrhea probably occurs in about one third of patients. Some people have reported abdominal pain as the first sign, she said.

“Now that we know about the more wide range of symptoms associated [with COVID-19], we are being much more open to considering people perhaps having this infection. There is a lower index of suspicion and much lower threshold for diagnostic testing,” Marrazzo said, adding that there are still many barriers to testing and getting test results.

Stark Racial Disparities Need Greater Understanding

The second major topic of discussion at the briefing was the growing realization of racial disparities in COVID-19.

“Racial disparities in our country are not new but racial disparities in this disease are pretty stark,” del Rio said. “We live in a country where disparities have really colored a lot of what our diseases are, from HIV to diabetes to hypertension, and it’s not surprising that we are seeing this now with COVID-19.”

Marrazzo noted that, in Alabama, around 20% of the population is African American, yet almost 40% of COVID-19 deaths are occurring in this population. “The most stark statistics are coming out of Illinois and Michigan, where less than around 15% of the population is African American and yet 70% of the deaths are occurring in that group,” she said.

Both del Rio and Marrazzo agreed that understanding the racial differences in COVID-19 deaths is going to require a lot of analysis in the coming months.

Part of it likely reflects the challenge of social distancing in urban areas, Marrazzo said. “Social distancing is a luxury afforded by having a really big space, and space is money.”

The other long-standing challenge of unequal access to healthcare also likely plays a role, she said. This includes missing out on preventive health appointments and screenings, which can translate into more comorbidities, particularly hypertension.

The evolving evidence about the virus, and the stark conditions that frontline clinicians face, make this an especially challenging public health crisis, del Rio said.

“Taking care of these patients is incredibly taxing and my hat is off to physicians, residents, nurses, everybody working on this in the hospitals because they are really doing a yeoman’s work,” he said.

“These are not easy patients to take care of. Not only are [the frontline clinicians] providing care, they are caring for the patient and providing a comfort and someone to listen to when family can’t be present,” del Rio emphasized.

New Guidelines

The IDSA just released new guidelines for diagnosis and treatment of COVID-19.

“We are learning new things every day about this virus. Things are rapidly changing, and as we learn new things we have to adapt and make changes,” del Rio said.

del Rio noted that the guildelines “will evolve and change as more information comes out.”

This article first appeared on Medscape.com.

Asymptomatic or presymptomatic for COVID-19? Experts with the Infectious Diseases Society of America (IDSA) discussed the shift in thinking between the two terms at a media briefing April 10.

They also addressed racial disparities surrounding COVID-19, and announced new IDSA guidelines for diagnosis and treatment of the illness.

Regarding the shifting thinking on symptoms and transmission of the novel coronavirus, when it comes to presymptomatic or asymptomatic, “pre” is really the right terminology, Carlos del Rio, MD, professor of medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, said during the briefing, because it’s not that people are asymptomatic but that they develop symptoms later and start transmitting the virus 24 to 48 hours before they develop symptoms.

“Clearly, this plays a role in transmission,” with some studies suggesting that 6% to 12% of transmissions occur during this presymptomatic stage, he explained.

Jeanne Marrazzo, MD, MPH, director of the Division of Infectious Diseases at University of Alabama at Birmingham, noted that early in the COVID-19 pandemic, the presymptomatic phase “could have been missed because we didn’t realize the wide ranging symptoms this disease has.”

This is turning out to be a “very interesting” virus with “fascinating” symptoms, she told reporters on the call.

The virus seems to have capacity to affect far more than just the respiratory tract. Initially, however, it was viewed “very much like a classic respiratory viral infection. As a result, a lot of people were refused testing because they were not showing the classic signs” of respiratory infection, Marrazzo noted.

It’s now clear that the range of symptoms is quite different, she said.

Notably, loss of smell seems to be “very characteristic and very specific to this infection. I can’t think of another common viral infection that causes loss of smell before you start to see other things,” Marrazzo said.

Data also suggest that gastrointestinal symptoms are common with COVID-19. Early data suggest that diarrhea probably occurs in about one third of patients. Some people have reported abdominal pain as the first sign, she said.

“Now that we know about the more wide range of symptoms associated [with COVID-19], we are being much more open to considering people perhaps having this infection. There is a lower index of suspicion and much lower threshold for diagnostic testing,” Marrazzo said, adding that there are still many barriers to testing and getting test results.

Stark Racial Disparities Need Greater Understanding

The second major topic of discussion at the briefing was the growing realization of racial disparities in COVID-19.

“Racial disparities in our country are not new but racial disparities in this disease are pretty stark,” del Rio said. “We live in a country where disparities have really colored a lot of what our diseases are, from HIV to diabetes to hypertension, and it’s not surprising that we are seeing this now with COVID-19.”

Marrazzo noted that, in Alabama, around 20% of the population is African American, yet almost 40% of COVID-19 deaths are occurring in this population. “The most stark statistics are coming out of Illinois and Michigan, where less than around 15% of the population is African American and yet 70% of the deaths are occurring in that group,” she said.

Both del Rio and Marrazzo agreed that understanding the racial differences in COVID-19 deaths is going to require a lot of analysis in the coming months.

Part of it likely reflects the challenge of social distancing in urban areas, Marrazzo said. “Social distancing is a luxury afforded by having a really big space, and space is money.”

The other long-standing challenge of unequal access to healthcare also likely plays a role, she said. This includes missing out on preventive health appointments and screenings, which can translate into more comorbidities, particularly hypertension.

The evolving evidence about the virus, and the stark conditions that frontline clinicians face, make this an especially challenging public health crisis, del Rio said.

“Taking care of these patients is incredibly taxing and my hat is off to physicians, residents, nurses, everybody working on this in the hospitals because they are really doing a yeoman’s work,” he said.

“These are not easy patients to take care of. Not only are [the frontline clinicians] providing care, they are caring for the patient and providing a comfort and someone to listen to when family can’t be present,” del Rio emphasized.

New Guidelines

The IDSA just released new guidelines for diagnosis and treatment of COVID-19.

“We are learning new things every day about this virus. Things are rapidly changing, and as we learn new things we have to adapt and make changes,” del Rio said.

del Rio noted that the guildelines “will evolve and change as more information comes out.”

This article first appeared on Medscape.com.

A physician couple who both had COVID-19 had very different responses — one ending up in intensive care, the other asymptomatic.

Their story, one of two people living together but with such different responses to the infection, illustrates how much is still to be learned about COVID-19, says Noopur Raje, MD, professor of medicine at Harvard Medical School and director of the Center for Multiple Myeloma at Massachusetts General Hospital (MGH) in Boston.

“After experiencing #Covid_19 from the patient/caregiver end despite both of us being physicians at a major academic medical center, this has been a challenge like no other I have experienced,” Raje (@NoopurRajeMD) wrote on Twitter.

She outlined their experiences in a Twitter thread and elaborated in an interview with Medscape Medical News.

Raje says that she wants clinicians to know how symptoms can evolve both quickly and suddenly.

She recalls how for 10 days, she cared for her COVID-19–positive husband at home, separated from him by a floor in their Boston townhouse and wearing a surgical mask and gloves to bring him food and fluids, as he was too weak to help himself.

Despite the high fevers, chills, extreme fatigue, and dramatic weight loss, Raje says she felt reasonably confident that her husband was getting better. His temperature had dropped from around 103 to 101, his heart rate was in the 80s, and his blood pressure was “OK,” she recalls.

But then Jag Singh, MD, an otherwise healthy 55-year-old Harvard professor and cardiologist, started to cough — and everything suddenly changed.

The cough sounded chesty, and he was weak and unwell. They decided that he needed medical help.

“I was planning on driving him to the hospital, but I ended up having to call 911, although we literally live across the street,” she said.

“We have stairs here and I wasn’t sure that he would be able to make it coming down with me trying to help him, so the safest thing was for me to call for help.”

Singh was admitted straight to the medical intensive care unit (MICU) while his wife waited at home.

“I was blown away when I saw Jag’s x-ray and CT scan and the bilateral pneumonia he had developed,” she commented. “I would not have believed it, the way he was clinically — and seeing that x-ray.

“Honestly, when I took him in to hospital, I thought he’d be there a couple of days — over the weekend — and I’d get him back Monday. But it didn’t turn out that way. He was there for about 9 days.”

That first night in the hospital, Singh consented to intubation — should he need it. “He called me then,” said Raje. “I said we’ve got to do what we’ve got to do, it’s OK — it is what it is, and we’ll do whatever it takes.”

He remained in the MICU overnight and through the next day, still breathing on his own, but with the looming prospect of mechanical ventilation.

“The good news is he maintained his oxygen saturations throughout,” said Raje. “I was able to see his vitals with EPIC [remote monitoring] ... It was crazy,” she recalls. “Seeing a respiratory rate of 26 was difficult. When you see that, you worry about somebody tiring with the breathing. His inflammatory markers kept climbing, his fevers persisted.”

Thankfully, he never needed the ventilator.

But by this time Raje had another worry: She, too, had tested positive and was now alone at home.

“I was unable to talk to my extended family as they all looked to us as physicians for support,” she tweeted. Both children came to Boston to see her, but she saw them only through a window.

Alone, she waited for the same symptoms that had slammed her husband; but they never came — something she wants caregivers to know.

“The fear and anxiety of taking care of somebody who’s COVID positive ... I am hoping that can be alleviated a little bit at least,” she said. “If you’ve been taking care of someone, chances are you’re probably positive already and if you’re not sick, the chances of you getting sick are really low, so don’t be afraid to take care of that person.”

Singh is recovering well at home now, almost a month into his illness. During the interview, conducted via Zoom, he could be heard coughing in the background.

While in the MICU, Singh was treated with azithromycin and hydroxychloroquine — standard at MGH for critically ill COVID-19 patients — and he was also enrolled into a double-blind, randomized, placebo-controlled trial of the investigational agent remdesivir (Gilead).

Raje is not sure what, if anything, helped him turn the corner.

“I saw his inflammatory markers get worse actually — I don’t think we can know if the drugs made a difference,” she says. “His first dose of hydroxychloroquine was Friday night when he was admitted, and the markers continued to climb until the next Thursday.”

In particular, his C-reactive protein (CRP) kept rising, reaching the 260 to 270 mg/dL range, “which to me was scary,” she said. “I do think he had a cytokine storm going, but I didn’t see those results.”

“Understanding the immune compartment is going to be so, so critically important and what it is that we can do to boost folks’ immune systems,” she said.

“If you have a very high viral load and your immune system is not 100% even though you’re otherwise healthy, you might be the person who ends up with that more serious response to this virus. Trying to study this in a focused way, looking at the immune compartment, looking at the antibody status, looking at the viral load — there’s so much more we need to look at. Until we get the vaccine, which is probably a year-and-a-half away, we need to look at how can we develop that herd immunity so we don’t have folks getting as critically ill as they do.”

Despite feeling perfectly healthy, Raje is still at home. Three weeks after her first test, she is still testing positive for COVID-19, waiting for two consecutive negative results 72 hours apart before she is allowed back to work at the hospital.

When she gets the green light, she plans to go work on the COVID-19 floor, if needed. “It’s people like us [who have had COVID-19] who have to get back in the trenches and do the work now,” she says.

“My biggest concern is that it’s a very isolating experience for the COVID-positive patient. We are doing complete-barrier nursing — they are completely alone. The only person who ever walks into the room is the nurse — and the physician goes in once a day. It’s so important that we don’t lose sight of compassion,” she says.

“That’s why, in terms of alleviating anxiety, it is so important we do antibody testing so that people can actually go in and take care of these folks.”

‘Look for red flag’

Raje wants physicians to warn their self-isolating patients and caregivers to look for red flags. “There are primary care physicians who reached out to me [after my tweets] and said ‘when someone calls me and says it’s been 5-7 days and I am still not feeling well, I am going to look at that more seriously.’

“Part of me wanting to share this experience was basically to dispel the notion that 2 weeks into this you’re going to be fine,” she said, because it is not widely appreciated, she feels that “in week 2, you could become pretty sick.”

This article first appeared on Medscape.com.

A physician couple who both had COVID-19 had very different responses — one ending up in intensive care, the other asymptomatic.

Their story, one of two people living together but with such different responses to the infection, illustrates how much is still to be learned about COVID-19, says Noopur Raje, MD, professor of medicine at Harvard Medical School and director of the Center for Multiple Myeloma at Massachusetts General Hospital (MGH) in Boston.

“After experiencing #Covid_19 from the patient/caregiver end despite both of us being physicians at a major academic medical center, this has been a challenge like no other I have experienced,” Raje (@NoopurRajeMD) wrote on Twitter.

She outlined their experiences in a Twitter thread and elaborated in an interview with Medscape Medical News.

Raje says that she wants clinicians to know how symptoms can evolve both quickly and suddenly.

She recalls how for 10 days, she cared for her COVID-19–positive husband at home, separated from him by a floor in their Boston townhouse and wearing a surgical mask and gloves to bring him food and fluids, as he was too weak to help himself.

Despite the high fevers, chills, extreme fatigue, and dramatic weight loss, Raje says she felt reasonably confident that her husband was getting better. His temperature had dropped from around 103 to 101, his heart rate was in the 80s, and his blood pressure was “OK,” she recalls.

But then Jag Singh, MD, an otherwise healthy 55-year-old Harvard professor and cardiologist, started to cough — and everything suddenly changed.

The cough sounded chesty, and he was weak and unwell. They decided that he needed medical help.

“I was planning on driving him to the hospital, but I ended up having to call 911, although we literally live across the street,” she said.

“We have stairs here and I wasn’t sure that he would be able to make it coming down with me trying to help him, so the safest thing was for me to call for help.”

Singh was admitted straight to the medical intensive care unit (MICU) while his wife waited at home.

“I was blown away when I saw Jag’s x-ray and CT scan and the bilateral pneumonia he had developed,” she commented. “I would not have believed it, the way he was clinically — and seeing that x-ray.

“Honestly, when I took him in to hospital, I thought he’d be there a couple of days — over the weekend — and I’d get him back Monday. But it didn’t turn out that way. He was there for about 9 days.”

That first night in the hospital, Singh consented to intubation — should he need it. “He called me then,” said Raje. “I said we’ve got to do what we’ve got to do, it’s OK — it is what it is, and we’ll do whatever it takes.”

He remained in the MICU overnight and through the next day, still breathing on his own, but with the looming prospect of mechanical ventilation.

“The good news is he maintained his oxygen saturations throughout,” said Raje. “I was able to see his vitals with EPIC [remote monitoring] ... It was crazy,” she recalls. “Seeing a respiratory rate of 26 was difficult. When you see that, you worry about somebody tiring with the breathing. His inflammatory markers kept climbing, his fevers persisted.”

Thankfully, he never needed the ventilator.

But by this time Raje had another worry: She, too, had tested positive and was now alone at home.

“I was unable to talk to my extended family as they all looked to us as physicians for support,” she tweeted. Both children came to Boston to see her, but she saw them only through a window.

Alone, she waited for the same symptoms that had slammed her husband; but they never came — something she wants caregivers to know.

“The fear and anxiety of taking care of somebody who’s COVID positive ... I am hoping that can be alleviated a little bit at least,” she said. “If you’ve been taking care of someone, chances are you’re probably positive already and if you’re not sick, the chances of you getting sick are really low, so don’t be afraid to take care of that person.”

Singh is recovering well at home now, almost a month into his illness. During the interview, conducted via Zoom, he could be heard coughing in the background.

While in the MICU, Singh was treated with azithromycin and hydroxychloroquine — standard at MGH for critically ill COVID-19 patients — and he was also enrolled into a double-blind, randomized, placebo-controlled trial of the investigational agent remdesivir (Gilead).

Raje is not sure what, if anything, helped him turn the corner.

“I saw his inflammatory markers get worse actually — I don’t think we can know if the drugs made a difference,” she says. “His first dose of hydroxychloroquine was Friday night when he was admitted, and the markers continued to climb until the next Thursday.”

In particular, his C-reactive protein (CRP) kept rising, reaching the 260 to 270 mg/dL range, “which to me was scary,” she said. “I do think he had a cytokine storm going, but I didn’t see those results.”

“Understanding the immune compartment is going to be so, so critically important and what it is that we can do to boost folks’ immune systems,” she said.

“If you have a very high viral load and your immune system is not 100% even though you’re otherwise healthy, you might be the person who ends up with that more serious response to this virus. Trying to study this in a focused way, looking at the immune compartment, looking at the antibody status, looking at the viral load — there’s so much more we need to look at. Until we get the vaccine, which is probably a year-and-a-half away, we need to look at how can we develop that herd immunity so we don’t have folks getting as critically ill as they do.”

Despite feeling perfectly healthy, Raje is still at home. Three weeks after her first test, she is still testing positive for COVID-19, waiting for two consecutive negative results 72 hours apart before she is allowed back to work at the hospital.

When she gets the green light, she plans to go work on the COVID-19 floor, if needed. “It’s people like us [who have had COVID-19] who have to get back in the trenches and do the work now,” she says.

“My biggest concern is that it’s a very isolating experience for the COVID-positive patient. We are doing complete-barrier nursing — they are completely alone. The only person who ever walks into the room is the nurse — and the physician goes in once a day. It’s so important that we don’t lose sight of compassion,” she says.

“That’s why, in terms of alleviating anxiety, it is so important we do antibody testing so that people can actually go in and take care of these folks.”

‘Look for red flag’

Raje wants physicians to warn their self-isolating patients and caregivers to look for red flags. “There are primary care physicians who reached out to me [after my tweets] and said ‘when someone calls me and says it’s been 5-7 days and I am still not feeling well, I am going to look at that more seriously.’

“Part of me wanting to share this experience was basically to dispel the notion that 2 weeks into this you’re going to be fine,” she said, because it is not widely appreciated, she feels that “in week 2, you could become pretty sick.”

This article first appeared on Medscape.com.

A physician couple who both had COVID-19 had very different responses — one ending up in intensive care, the other asymptomatic.

Their story, one of two people living together but with such different responses to the infection, illustrates how much is still to be learned about COVID-19, says Noopur Raje, MD, professor of medicine at Harvard Medical School and director of the Center for Multiple Myeloma at Massachusetts General Hospital (MGH) in Boston.

“After experiencing #Covid_19 from the patient/caregiver end despite both of us being physicians at a major academic medical center, this has been a challenge like no other I have experienced,” Raje (@NoopurRajeMD) wrote on Twitter.

She outlined their experiences in a Twitter thread and elaborated in an interview with Medscape Medical News.

Raje says that she wants clinicians to know how symptoms can evolve both quickly and suddenly.

She recalls how for 10 days, she cared for her COVID-19–positive husband at home, separated from him by a floor in their Boston townhouse and wearing a surgical mask and gloves to bring him food and fluids, as he was too weak to help himself.

Despite the high fevers, chills, extreme fatigue, and dramatic weight loss, Raje says she felt reasonably confident that her husband was getting better. His temperature had dropped from around 103 to 101, his heart rate was in the 80s, and his blood pressure was “OK,” she recalls.

But then Jag Singh, MD, an otherwise healthy 55-year-old Harvard professor and cardiologist, started to cough — and everything suddenly changed.

The cough sounded chesty, and he was weak and unwell. They decided that he needed medical help.

“I was planning on driving him to the hospital, but I ended up having to call 911, although we literally live across the street,” she said.

“We have stairs here and I wasn’t sure that he would be able to make it coming down with me trying to help him, so the safest thing was for me to call for help.”

Singh was admitted straight to the medical intensive care unit (MICU) while his wife waited at home.

“I was blown away when I saw Jag’s x-ray and CT scan and the bilateral pneumonia he had developed,” she commented. “I would not have believed it, the way he was clinically — and seeing that x-ray.

“Honestly, when I took him in to hospital, I thought he’d be there a couple of days — over the weekend — and I’d get him back Monday. But it didn’t turn out that way. He was there for about 9 days.”

That first night in the hospital, Singh consented to intubation — should he need it. “He called me then,” said Raje. “I said we’ve got to do what we’ve got to do, it’s OK — it is what it is, and we’ll do whatever it takes.”

He remained in the MICU overnight and through the next day, still breathing on his own, but with the looming prospect of mechanical ventilation.

“The good news is he maintained his oxygen saturations throughout,” said Raje. “I was able to see his vitals with EPIC [remote monitoring] ... It was crazy,” she recalls. “Seeing a respiratory rate of 26 was difficult. When you see that, you worry about somebody tiring with the breathing. His inflammatory markers kept climbing, his fevers persisted.”

Thankfully, he never needed the ventilator.

But by this time Raje had another worry: She, too, had tested positive and was now alone at home.

“I was unable to talk to my extended family as they all looked to us as physicians for support,” she tweeted. Both children came to Boston to see her, but she saw them only through a window.

Alone, she waited for the same symptoms that had slammed her husband; but they never came — something she wants caregivers to know.

“The fear and anxiety of taking care of somebody who’s COVID positive ... I am hoping that can be alleviated a little bit at least,” she said. “If you’ve been taking care of someone, chances are you’re probably positive already and if you’re not sick, the chances of you getting sick are really low, so don’t be afraid to take care of that person.”

Singh is recovering well at home now, almost a month into his illness. During the interview, conducted via Zoom, he could be heard coughing in the background.

While in the MICU, Singh was treated with azithromycin and hydroxychloroquine — standard at MGH for critically ill COVID-19 patients — and he was also enrolled into a double-blind, randomized, placebo-controlled trial of the investigational agent remdesivir (Gilead).

Raje is not sure what, if anything, helped him turn the corner.

“I saw his inflammatory markers get worse actually — I don’t think we can know if the drugs made a difference,” she says. “His first dose of hydroxychloroquine was Friday night when he was admitted, and the markers continued to climb until the next Thursday.”

In particular, his C-reactive protein (CRP) kept rising, reaching the 260 to 270 mg/dL range, “which to me was scary,” she said. “I do think he had a cytokine storm going, but I didn’t see those results.”

“Understanding the immune compartment is going to be so, so critically important and what it is that we can do to boost folks’ immune systems,” she said.

“If you have a very high viral load and your immune system is not 100% even though you’re otherwise healthy, you might be the person who ends up with that more serious response to this virus. Trying to study this in a focused way, looking at the immune compartment, looking at the antibody status, looking at the viral load — there’s so much more we need to look at. Until we get the vaccine, which is probably a year-and-a-half away, we need to look at how can we develop that herd immunity so we don’t have folks getting as critically ill as they do.”

Despite feeling perfectly healthy, Raje is still at home. Three weeks after her first test, she is still testing positive for COVID-19, waiting for two consecutive negative results 72 hours apart before she is allowed back to work at the hospital.

When she gets the green light, she plans to go work on the COVID-19 floor, if needed. “It’s people like us [who have had COVID-19] who have to get back in the trenches and do the work now,” she says.

“My biggest concern is that it’s a very isolating experience for the COVID-positive patient. We are doing complete-barrier nursing — they are completely alone. The only person who ever walks into the room is the nurse — and the physician goes in once a day. It’s so important that we don’t lose sight of compassion,” she says.

“That’s why, in terms of alleviating anxiety, it is so important we do antibody testing so that people can actually go in and take care of these folks.”

‘Look for red flag’

Raje wants physicians to warn their self-isolating patients and caregivers to look for red flags. “There are primary care physicians who reached out to me [after my tweets] and said ‘when someone calls me and says it’s been 5-7 days and I am still not feeling well, I am going to look at that more seriously.’

“Part of me wanting to share this experience was basically to dispel the notion that 2 weeks into this you’re going to be fine,” she said, because it is not widely appreciated, she feels that “in week 2, you could become pretty sick.”

This article first appeared on Medscape.com.

A social worker in New York City was home, caring for his sick son, when the hospital at which he works ordered him to report back to work. His son had COVID-19, yet his hospital told him he had to show up in person.

The social worker’s situation is just one of many NYC Health + Hospitals employees who could work remotely yet are required to report in person. His circumstances were described in a letter sent by Lichten & Bright, a law firm representing the New York City Health Services Employees Union, Local 768.

“Despite the fact that all or virtually all of the work social workers perform can be done remotely, only a handful…are being permitted to work from home,” said the letter, which was written on behalf of about 1000 social workers and 150 medical records specialists and addressed to NYC H+H CEO Mitchell Katz, MD.

Most social workers stopped seeing patients in person in early March. But many still face crowded conditions at several points during their work day. They take public transportation to work, come face-to-face with other health care workers and patients in elevators, and some attend daily meetings with up to 10 employees in conference rooms too small to stay six feet apart, the letter says.

“The social workers are scared to go to work,” said Daniel Bright, the letter’s author. “They’re baffled by the lack of any management response that would allow them to work from home. They are worried about getting exposed to the coronavirus while riding the subway or the bus to work or at work from a doctor or nurse or patient, and getting sick themselves or taking it home to their families.”

There is no good reason that the social workers should be compelled to be physically at work during the COVID-19 pandemic, Bright said. The handful of social workers at NYC H+H’s World Trade Center Environmental Health Center clinic at Bellevue who have been allowed to work from home on an ad hoc basis, he said, have done so successfully.

In response to Bright’s letter, the hospital system issued a statement that seemed to downplay workers’ assessment of the situation, and included the following: “NYC Health + Hospital social workers…play different roles in our system, from acting as front-line providers to navigating safe discharges and helping patients and families with important health care decisions. Depending on the facility, the department, and the role they play, decisions are made by our hospital leaders on whether their critical work could be done remotely.”

Recently, many medical associations have issued statements supporting the rights of health care workers to speak up without fear of repercussion. But NYC H+H social workers have been complying with the orders because they say they’re scared of retaliation: In daily video conference calls, an administrator at one of NYC H+H’s hospitals has shown exasperation when asked about working from home, multiple employees told Medscape Medical News. And other questions, they said, such as whether staff could receive hazard pay, were scoffed at. Instead, the administration mentioned disciplinary action for those who didn’t show up to work.

During Thursday’s call, a recording of which was obtained by Medscape, the CEO of one NYC H+H hospital chastised his employees for taking their concerns to the press.

“People are just taking things and you know, using things for their benefit to be able to create problems for us who are trying to do our jobs,” he said, adding that he refuses to be bullied or blackmailed and that he’ll continue to do what he needs to do as CEO — but he wanted people to know “some of the garbage I have to deal with.”

He also reminded employees of documentation people need to provide if they don’t come in to work for being sick or taking a personal leave so the hospital can verify that “you have a condition that warrants you being out.”

Christopher Miller, a spokesperson for the hospital system, said that “some employees in certain functions may be approved to telecommute.” But employees contacted by Medscape who see all of their clients remotely said their requests to telecommute have not been approved.

At this point, it’s no longer a theoretical problem. COVID-19 appears to have spread among a cluster of people reporting to work in one of the H+H hospitals, employees said. In some cases, employees’ family members also became ill.

This article first appeared on Medscape.com.

A social worker in New York City was home, caring for his sick son, when the hospital at which he works ordered him to report back to work. His son had COVID-19, yet his hospital told him he had to show up in person.

The social worker’s situation is just one of many NYC Health + Hospitals employees who could work remotely yet are required to report in person. His circumstances were described in a letter sent by Lichten & Bright, a law firm representing the New York City Health Services Employees Union, Local 768.

“Despite the fact that all or virtually all of the work social workers perform can be done remotely, only a handful…are being permitted to work from home,” said the letter, which was written on behalf of about 1000 social workers and 150 medical records specialists and addressed to NYC H+H CEO Mitchell Katz, MD.

Most social workers stopped seeing patients in person in early March. But many still face crowded conditions at several points during their work day. They take public transportation to work, come face-to-face with other health care workers and patients in elevators, and some attend daily meetings with up to 10 employees in conference rooms too small to stay six feet apart, the letter says.

“The social workers are scared to go to work,” said Daniel Bright, the letter’s author. “They’re baffled by the lack of any management response that would allow them to work from home. They are worried about getting exposed to the coronavirus while riding the subway or the bus to work or at work from a doctor or nurse or patient, and getting sick themselves or taking it home to their families.”

There is no good reason that the social workers should be compelled to be physically at work during the COVID-19 pandemic, Bright said. The handful of social workers at NYC H+H’s World Trade Center Environmental Health Center clinic at Bellevue who have been allowed to work from home on an ad hoc basis, he said, have done so successfully.

In response to Bright’s letter, the hospital system issued a statement that seemed to downplay workers’ assessment of the situation, and included the following: “NYC Health + Hospital social workers…play different roles in our system, from acting as front-line providers to navigating safe discharges and helping patients and families with important health care decisions. Depending on the facility, the department, and the role they play, decisions are made by our hospital leaders on whether their critical work could be done remotely.”

Recently, many medical associations have issued statements supporting the rights of health care workers to speak up without fear of repercussion. But NYC H+H social workers have been complying with the orders because they say they’re scared of retaliation: In daily video conference calls, an administrator at one of NYC H+H’s hospitals has shown exasperation when asked about working from home, multiple employees told Medscape Medical News. And other questions, they said, such as whether staff could receive hazard pay, were scoffed at. Instead, the administration mentioned disciplinary action for those who didn’t show up to work.

During Thursday’s call, a recording of which was obtained by Medscape, the CEO of one NYC H+H hospital chastised his employees for taking their concerns to the press.

“People are just taking things and you know, using things for their benefit to be able to create problems for us who are trying to do our jobs,” he said, adding that he refuses to be bullied or blackmailed and that he’ll continue to do what he needs to do as CEO — but he wanted people to know “some of the garbage I have to deal with.”

He also reminded employees of documentation people need to provide if they don’t come in to work for being sick or taking a personal leave so the hospital can verify that “you have a condition that warrants you being out.”

Christopher Miller, a spokesperson for the hospital system, said that “some employees in certain functions may be approved to telecommute.” But employees contacted by Medscape who see all of their clients remotely said their requests to telecommute have not been approved.

At this point, it’s no longer a theoretical problem. COVID-19 appears to have spread among a cluster of people reporting to work in one of the H+H hospitals, employees said. In some cases, employees’ family members also became ill.

This article first appeared on Medscape.com.

A social worker in New York City was home, caring for his sick son, when the hospital at which he works ordered him to report back to work. His son had COVID-19, yet his hospital told him he had to show up in person.

The social worker’s situation is just one of many NYC Health + Hospitals employees who could work remotely yet are required to report in person. His circumstances were described in a letter sent by Lichten & Bright, a law firm representing the New York City Health Services Employees Union, Local 768.

“Despite the fact that all or virtually all of the work social workers perform can be done remotely, only a handful…are being permitted to work from home,” said the letter, which was written on behalf of about 1000 social workers and 150 medical records specialists and addressed to NYC H+H CEO Mitchell Katz, MD.

Most social workers stopped seeing patients in person in early March. But many still face crowded conditions at several points during their work day. They take public transportation to work, come face-to-face with other health care workers and patients in elevators, and some attend daily meetings with up to 10 employees in conference rooms too small to stay six feet apart, the letter says.

“The social workers are scared to go to work,” said Daniel Bright, the letter’s author. “They’re baffled by the lack of any management response that would allow them to work from home. They are worried about getting exposed to the coronavirus while riding the subway or the bus to work or at work from a doctor or nurse or patient, and getting sick themselves or taking it home to their families.”

There is no good reason that the social workers should be compelled to be physically at work during the COVID-19 pandemic, Bright said. The handful of social workers at NYC H+H’s World Trade Center Environmental Health Center clinic at Bellevue who have been allowed to work from home on an ad hoc basis, he said, have done so successfully.

In response to Bright’s letter, the hospital system issued a statement that seemed to downplay workers’ assessment of the situation, and included the following: “NYC Health + Hospital social workers…play different roles in our system, from acting as front-line providers to navigating safe discharges and helping patients and families with important health care decisions. Depending on the facility, the department, and the role they play, decisions are made by our hospital leaders on whether their critical work could be done remotely.”

Recently, many medical associations have issued statements supporting the rights of health care workers to speak up without fear of repercussion. But NYC H+H social workers have been complying with the orders because they say they’re scared of retaliation: In daily video conference calls, an administrator at one of NYC H+H’s hospitals has shown exasperation when asked about working from home, multiple employees told Medscape Medical News. And other questions, they said, such as whether staff could receive hazard pay, were scoffed at. Instead, the administration mentioned disciplinary action for those who didn’t show up to work.

During Thursday’s call, a recording of which was obtained by Medscape, the CEO of one NYC H+H hospital chastised his employees for taking their concerns to the press.

“People are just taking things and you know, using things for their benefit to be able to create problems for us who are trying to do our jobs,” he said, adding that he refuses to be bullied or blackmailed and that he’ll continue to do what he needs to do as CEO — but he wanted people to know “some of the garbage I have to deal with.”

He also reminded employees of documentation people need to provide if they don’t come in to work for being sick or taking a personal leave so the hospital can verify that “you have a condition that warrants you being out.”

Christopher Miller, a spokesperson for the hospital system, said that “some employees in certain functions may be approved to telecommute.” But employees contacted by Medscape who see all of their clients remotely said their requests to telecommute have not been approved.

At this point, it’s no longer a theoretical problem. COVID-19 appears to have spread among a cluster of people reporting to work in one of the H+H hospitals, employees said. In some cases, employees’ family members also became ill.

This article first appeared on Medscape.com.

The current coronavirus disease 2019 (COVID-19) pandemic shocked the world with its rapid spread despite stringent containment efforts, and it continues to wreak havoc. The surrounding uncertainty due to the novelty of this virus has prompted significant investigation to determine proper containment, treatment, and eradication efforts.^1,2 In addition, health care facilities are facing surge capacity issues and a shortage of resources resulting in lower quality care for patients and putting health care workers (HCWs) at risk for infection.^3,4

While there is a lot of emerging clinical and basic science research in this area, there has been inconsistent guidance in regard to the containment and prevention of spread in health care systems. An initiative to minimize HCW exposure risk and to provide the highest quality care to patients was implemented by the Section of Hospital Medicine at our large academic medical center. We used a hospital medicine medical-surgical unit and converted it into a Person Under Investigation (PUI) unit for patients suspected of COVID-19.
 

Unit goals

• Deliver dedicated, comprehensive, and high-quality care to our PUI patients suspected of COVID-19.
• Minimize cross contamination with healthy patients on other hospital units.
• Provide clear and direct communications with our HCWs.
• Educate HCWs on optimal donning and doffing techniques.
• Minimize our HCW exposure risk.
• Efficiently use our personal protective equipment (PPE) supply.

Unit and team characteristics

We used a preexisting 24-bed hospital medicine medical-surgical unit with a dyad rounding model of an attending physician and advanced practice provider (APP). Other team members include a designated care coordinator (social worker/case manager), pharmacist, respiratory therapist, physical/occupational therapist, speech language pathologist, unit medical director, and nurse manager. A daily multidisciplinary huddle with all the team members was held to discuss the care of the PUI patients.

Administrative leadership

A COVID-19 task force composed of the medical director of clinical operations from the Section of Hospital Medicine, infectious disease, infection prevention, and several other important stakeholders conducted a daily conference call. This call allowed for the dissemination of information, including any treatment updates based on literature review or care processes. This information was then relayed to the HCWs following the meeting through the PUI unit medical director and nurse manager, who also facilitated feedback from the HCWs to the COVID-19 task force during the daily conference call. (See Figure 1.)

Courtesy Dr. Sunkara, Dr. Lippert, Dr. Morris, and Dr. Huang

Patient flow

Hospital medicine was designated as the default service for all PUI patients suspected of COVID-19 and confirmed COVID-19 cases requiring hospitalization. These patients were admitted to this PUI unit directly from the emergency department (ED), or as transfers from outside institutions with assistance from our patient placement specialist team. Those patients admitted from our ED were tested for COVID-19 prior to arriving on the unit. Other suspected COVID-19 patients arriving as transfers from outside institutions were screened by the patient placement specialist team asking the following questions about the patient:

• “Has the patient had a fever or cough and been in contact with a laboratory-confirmed COVID-19 patient?”
• “Has the patient had a fever and cough?”

If the answer to either screening question was “yes,” then the patient was accepted to the PUI unit and tested upon arrival. Lastly, patients who were found to be COVID-19 positive at the outside institution, but who required transfer for other clinical reasons, were placed on this PUI unit as well.

Mechanisms to efficiently utilize PPE and mitigate HCW exposure risk

Our objectives are reducing the number of HCWs encountering PUI patients, reducing the number of encounters the HCWs have with PUI patients, and reducing the amount of time HCWs spent with PUI patients.

First, we maintained a log outside each patient’s room to track the details of staff encounters. Second, there was only one medical provider (either the attending physician or APP) assigned to each patient to limit personnel exposure. Third, we removed all learners (e.g. residents and students) from this unit. Fourth, we limited the number of entries into patient rooms to only critical staff directly involved in patient care (e.g. dietary and other ancillary staff were not allowed to enter the rooms) and provided updates to the patients by calling into the rooms. In addition, care coordination, pharmacy, and other staff members also utilized the same approach of calling into the room to speak with the patient regarding updates to minimize the duration of time spent in the room. Furthermore, our medical providers – with the help of the pharmacist and nursing – timed a patient’s medications to help reduce the number of entries into the room.

Other things to consider for your PUI unit

There are several ideas that were not implemented in our PUI unit, but something to consider for your PUI unit, including:

• The use of elongated intravenous (IV) tubing, such that the IV poles and pumps were stationed outside the patient’s room, would be useful in reducing the amount of PPE required as well as HCW exposure to the patient.
• Having designated chest radiography, computed tomography, and magnetic resonance imaging scanners for these PUI patients to help minimize contamination with our non-PUI patients and to standardize the cleaning process.
• Supply our HCWs with designated scrubs at the beginning of their shifts, such that they can discard them at the end of their shifts for decontamination/sterilization purposes. This would help reduce HCWs fear of potentially exposing their families at home.
• Supply our HCWs with a designated place to stay, such as a hotel or other living quarters, to reduce HCWs fear of potentially exposing their families at home.
• Although we encouraged providers and staff to utilize designated phones to conduct patient history and review of systems information-gathering, to decrease the time spent in the room, the availability of more sophisticated audiovisual equipment could also improve the quality of the interview.

Conclusions

The increasing incidence in suspected COVID-19 patients has led to significant strain on health care systems of the world along with the associated economic and social crisis. Some health care facilities are facing surge capacity issues and inadequate resources, while others are facing a humanitarian crisis. Overall, we are all being affected by this pandemic, but are most concerned about its effects on our HCWs and our patients.

To address the concerns of low-quality care to our patients and anxiety levels among HCWs, we created this dedicated PUI unit in an effort to provide high-quality care for these suspected (and confirmed) COVID-19 patients and to maintain clear direct and constant communication with our HCWs.
 

Dr. Sunkara (psunkara@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine, Winston-Salem, N.C. He is the medical director for Hospital Medicine Units and the newly established PUI Unit, and is the corresponding author for this article. Dr. Lippert (wlippert@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine. Dr. Morris (chrmorri@wakehealth.edu) is a PGY-3 internal medicine resident at Wake Forest School of Medicine. Dr. Huang (chuang@wakehealth.edu) is associate professor of internal medicine at Wake Forest School of Medicine.

References

1. Food and Drug Administration. Recommendations for investigational COVID-19 convalescent plasma. 2020 Apr 8.

2. Fauci AS et al. Covid-19 – Navigating the uncharted. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMe2002387. 3. Emanuel EJ et al. Fair allocation of scarce medical resources in the time of Covid-19. N Engl J Med. 2020 Mar 23. doi: 10.1056/NEJMsb2005114.

4. Li Ran et al. Risk factors of healthcare workers with corona virus disease 2019: A retrospective cohort study in a designated hospital of Wuhan in China. Clin Infect Dis. 2020 Mar 17. doi: 10.1093/cid/ciaa287.

5. Krein SL et al. Identification and characterization of failures in infectious agent transmission precaution practices in hospitals: A qualitative study. JAMA Intern Med. 2018;178(8):1016-57. doi: 10.1001/jamainternmed.2018.1898.

The current coronavirus disease 2019 (COVID-19) pandemic shocked the world with its rapid spread despite stringent containment efforts, and it continues to wreak havoc. The surrounding uncertainty due to the novelty of this virus has prompted significant investigation to determine proper containment, treatment, and eradication efforts.^1,2 In addition, health care facilities are facing surge capacity issues and a shortage of resources resulting in lower quality care for patients and putting health care workers (HCWs) at risk for infection.^3,4

While there is a lot of emerging clinical and basic science research in this area, there has been inconsistent guidance in regard to the containment and prevention of spread in health care systems. An initiative to minimize HCW exposure risk and to provide the highest quality care to patients was implemented by the Section of Hospital Medicine at our large academic medical center. We used a hospital medicine medical-surgical unit and converted it into a Person Under Investigation (PUI) unit for patients suspected of COVID-19.
 

Unit goals

• Deliver dedicated, comprehensive, and high-quality care to our PUI patients suspected of COVID-19.
• Minimize cross contamination with healthy patients on other hospital units.
• Provide clear and direct communications with our HCWs.
• Educate HCWs on optimal donning and doffing techniques.
• Minimize our HCW exposure risk.
• Efficiently use our personal protective equipment (PPE) supply.

Unit and team characteristics

We used a preexisting 24-bed hospital medicine medical-surgical unit with a dyad rounding model of an attending physician and advanced practice provider (APP). Other team members include a designated care coordinator (social worker/case manager), pharmacist, respiratory therapist, physical/occupational therapist, speech language pathologist, unit medical director, and nurse manager. A daily multidisciplinary huddle with all the team members was held to discuss the care of the PUI patients.

Administrative leadership

A COVID-19 task force composed of the medical director of clinical operations from the Section of Hospital Medicine, infectious disease, infection prevention, and several other important stakeholders conducted a daily conference call. This call allowed for the dissemination of information, including any treatment updates based on literature review or care processes. This information was then relayed to the HCWs following the meeting through the PUI unit medical director and nurse manager, who also facilitated feedback from the HCWs to the COVID-19 task force during the daily conference call. (See Figure 1.)

Courtesy Dr. Sunkara, Dr. Lippert, Dr. Morris, and Dr. Huang

Patient flow

Hospital medicine was designated as the default service for all PUI patients suspected of COVID-19 and confirmed COVID-19 cases requiring hospitalization. These patients were admitted to this PUI unit directly from the emergency department (ED), or as transfers from outside institutions with assistance from our patient placement specialist team. Those patients admitted from our ED were tested for COVID-19 prior to arriving on the unit. Other suspected COVID-19 patients arriving as transfers from outside institutions were screened by the patient placement specialist team asking the following questions about the patient:

• “Has the patient had a fever or cough and been in contact with a laboratory-confirmed COVID-19 patient?”
• “Has the patient had a fever and cough?”

If the answer to either screening question was “yes,” then the patient was accepted to the PUI unit and tested upon arrival. Lastly, patients who were found to be COVID-19 positive at the outside institution, but who required transfer for other clinical reasons, were placed on this PUI unit as well.

Mechanisms to efficiently utilize PPE and mitigate HCW exposure risk

Our objectives are reducing the number of HCWs encountering PUI patients, reducing the number of encounters the HCWs have with PUI patients, and reducing the amount of time HCWs spent with PUI patients.

First, we maintained a log outside each patient’s room to track the details of staff encounters. Second, there was only one medical provider (either the attending physician or APP) assigned to each patient to limit personnel exposure. Third, we removed all learners (e.g. residents and students) from this unit. Fourth, we limited the number of entries into patient rooms to only critical staff directly involved in patient care (e.g. dietary and other ancillary staff were not allowed to enter the rooms) and provided updates to the patients by calling into the rooms. In addition, care coordination, pharmacy, and other staff members also utilized the same approach of calling into the room to speak with the patient regarding updates to minimize the duration of time spent in the room. Furthermore, our medical providers – with the help of the pharmacist and nursing – timed a patient’s medications to help reduce the number of entries into the room.

Other things to consider for your PUI unit

There are several ideas that were not implemented in our PUI unit, but something to consider for your PUI unit, including:

• The use of elongated intravenous (IV) tubing, such that the IV poles and pumps were stationed outside the patient’s room, would be useful in reducing the amount of PPE required as well as HCW exposure to the patient.
• Having designated chest radiography, computed tomography, and magnetic resonance imaging scanners for these PUI patients to help minimize contamination with our non-PUI patients and to standardize the cleaning process.
• Supply our HCWs with designated scrubs at the beginning of their shifts, such that they can discard them at the end of their shifts for decontamination/sterilization purposes. This would help reduce HCWs fear of potentially exposing their families at home.
• Supply our HCWs with a designated place to stay, such as a hotel or other living quarters, to reduce HCWs fear of potentially exposing their families at home.
• Although we encouraged providers and staff to utilize designated phones to conduct patient history and review of systems information-gathering, to decrease the time spent in the room, the availability of more sophisticated audiovisual equipment could also improve the quality of the interview.

Conclusions

The increasing incidence in suspected COVID-19 patients has led to significant strain on health care systems of the world along with the associated economic and social crisis. Some health care facilities are facing surge capacity issues and inadequate resources, while others are facing a humanitarian crisis. Overall, we are all being affected by this pandemic, but are most concerned about its effects on our HCWs and our patients.

To address the concerns of low-quality care to our patients and anxiety levels among HCWs, we created this dedicated PUI unit in an effort to provide high-quality care for these suspected (and confirmed) COVID-19 patients and to maintain clear direct and constant communication with our HCWs.
 

Dr. Sunkara (psunkara@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine, Winston-Salem, N.C. He is the medical director for Hospital Medicine Units and the newly established PUI Unit, and is the corresponding author for this article. Dr. Lippert (wlippert@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine. Dr. Morris (chrmorri@wakehealth.edu) is a PGY-3 internal medicine resident at Wake Forest School of Medicine. Dr. Huang (chuang@wakehealth.edu) is associate professor of internal medicine at Wake Forest School of Medicine.

References

1. Food and Drug Administration. Recommendations for investigational COVID-19 convalescent plasma. 2020 Apr 8.

2. Fauci AS et al. Covid-19 – Navigating the uncharted. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMe2002387. 3. Emanuel EJ et al. Fair allocation of scarce medical resources in the time of Covid-19. N Engl J Med. 2020 Mar 23. doi: 10.1056/NEJMsb2005114.

4. Li Ran et al. Risk factors of healthcare workers with corona virus disease 2019: A retrospective cohort study in a designated hospital of Wuhan in China. Clin Infect Dis. 2020 Mar 17. doi: 10.1093/cid/ciaa287.

5. Krein SL et al. Identification and characterization of failures in infectious agent transmission precaution practices in hospitals: A qualitative study. JAMA Intern Med. 2018;178(8):1016-57. doi: 10.1001/jamainternmed.2018.1898.

The current coronavirus disease 2019 (COVID-19) pandemic shocked the world with its rapid spread despite stringent containment efforts, and it continues to wreak havoc. The surrounding uncertainty due to the novelty of this virus has prompted significant investigation to determine proper containment, treatment, and eradication efforts.^1,2 In addition, health care facilities are facing surge capacity issues and a shortage of resources resulting in lower quality care for patients and putting health care workers (HCWs) at risk for infection.^3,4

While there is a lot of emerging clinical and basic science research in this area, there has been inconsistent guidance in regard to the containment and prevention of spread in health care systems. An initiative to minimize HCW exposure risk and to provide the highest quality care to patients was implemented by the Section of Hospital Medicine at our large academic medical center. We used a hospital medicine medical-surgical unit and converted it into a Person Under Investigation (PUI) unit for patients suspected of COVID-19.
 

Unit goals

• Deliver dedicated, comprehensive, and high-quality care to our PUI patients suspected of COVID-19.
• Minimize cross contamination with healthy patients on other hospital units.
• Provide clear and direct communications with our HCWs.
• Educate HCWs on optimal donning and doffing techniques.
• Minimize our HCW exposure risk.
• Efficiently use our personal protective equipment (PPE) supply.

Unit and team characteristics

We used a preexisting 24-bed hospital medicine medical-surgical unit with a dyad rounding model of an attending physician and advanced practice provider (APP). Other team members include a designated care coordinator (social worker/case manager), pharmacist, respiratory therapist, physical/occupational therapist, speech language pathologist, unit medical director, and nurse manager. A daily multidisciplinary huddle with all the team members was held to discuss the care of the PUI patients.

Administrative leadership

A COVID-19 task force composed of the medical director of clinical operations from the Section of Hospital Medicine, infectious disease, infection prevention, and several other important stakeholders conducted a daily conference call. This call allowed for the dissemination of information, including any treatment updates based on literature review or care processes. This information was then relayed to the HCWs following the meeting through the PUI unit medical director and nurse manager, who also facilitated feedback from the HCWs to the COVID-19 task force during the daily conference call. (See Figure 1.)

Courtesy Dr. Sunkara, Dr. Lippert, Dr. Morris, and Dr. Huang

Patient flow

Hospital medicine was designated as the default service for all PUI patients suspected of COVID-19 and confirmed COVID-19 cases requiring hospitalization. These patients were admitted to this PUI unit directly from the emergency department (ED), or as transfers from outside institutions with assistance from our patient placement specialist team. Those patients admitted from our ED were tested for COVID-19 prior to arriving on the unit. Other suspected COVID-19 patients arriving as transfers from outside institutions were screened by the patient placement specialist team asking the following questions about the patient:

• “Has the patient had a fever or cough and been in contact with a laboratory-confirmed COVID-19 patient?”
• “Has the patient had a fever and cough?”

If the answer to either screening question was “yes,” then the patient was accepted to the PUI unit and tested upon arrival. Lastly, patients who were found to be COVID-19 positive at the outside institution, but who required transfer for other clinical reasons, were placed on this PUI unit as well.

Mechanisms to efficiently utilize PPE and mitigate HCW exposure risk

Our objectives are reducing the number of HCWs encountering PUI patients, reducing the number of encounters the HCWs have with PUI patients, and reducing the amount of time HCWs spent with PUI patients.

First, we maintained a log outside each patient’s room to track the details of staff encounters. Second, there was only one medical provider (either the attending physician or APP) assigned to each patient to limit personnel exposure. Third, we removed all learners (e.g. residents and students) from this unit. Fourth, we limited the number of entries into patient rooms to only critical staff directly involved in patient care (e.g. dietary and other ancillary staff were not allowed to enter the rooms) and provided updates to the patients by calling into the rooms. In addition, care coordination, pharmacy, and other staff members also utilized the same approach of calling into the room to speak with the patient regarding updates to minimize the duration of time spent in the room. Furthermore, our medical providers – with the help of the pharmacist and nursing – timed a patient’s medications to help reduce the number of entries into the room.

Other things to consider for your PUI unit

There are several ideas that were not implemented in our PUI unit, but something to consider for your PUI unit, including:

• The use of elongated intravenous (IV) tubing, such that the IV poles and pumps were stationed outside the patient’s room, would be useful in reducing the amount of PPE required as well as HCW exposure to the patient.
• Having designated chest radiography, computed tomography, and magnetic resonance imaging scanners for these PUI patients to help minimize contamination with our non-PUI patients and to standardize the cleaning process.
• Supply our HCWs with designated scrubs at the beginning of their shifts, such that they can discard them at the end of their shifts for decontamination/sterilization purposes. This would help reduce HCWs fear of potentially exposing their families at home.
• Supply our HCWs with a designated place to stay, such as a hotel or other living quarters, to reduce HCWs fear of potentially exposing their families at home.
• Although we encouraged providers and staff to utilize designated phones to conduct patient history and review of systems information-gathering, to decrease the time spent in the room, the availability of more sophisticated audiovisual equipment could also improve the quality of the interview.

Conclusions

The increasing incidence in suspected COVID-19 patients has led to significant strain on health care systems of the world along with the associated economic and social crisis. Some health care facilities are facing surge capacity issues and inadequate resources, while others are facing a humanitarian crisis. Overall, we are all being affected by this pandemic, but are most concerned about its effects on our HCWs and our patients.

To address the concerns of low-quality care to our patients and anxiety levels among HCWs, we created this dedicated PUI unit in an effort to provide high-quality care for these suspected (and confirmed) COVID-19 patients and to maintain clear direct and constant communication with our HCWs.
 

Dr. Sunkara (psunkara@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine, Winston-Salem, N.C. He is the medical director for Hospital Medicine Units and the newly established PUI Unit, and is the corresponding author for this article. Dr. Lippert (wlippert@wakehealth.edu) is assistant professor of internal medicine at Wake Forest School of Medicine. Dr. Morris (chrmorri@wakehealth.edu) is a PGY-3 internal medicine resident at Wake Forest School of Medicine. Dr. Huang (chuang@wakehealth.edu) is associate professor of internal medicine at Wake Forest School of Medicine.

References

1. Food and Drug Administration. Recommendations for investigational COVID-19 convalescent plasma. 2020 Apr 8.

2. Fauci AS et al. Covid-19 – Navigating the uncharted. N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMe2002387. 3. Emanuel EJ et al. Fair allocation of scarce medical resources in the time of Covid-19. N Engl J Med. 2020 Mar 23. doi: 10.1056/NEJMsb2005114.

4. Li Ran et al. Risk factors of healthcare workers with corona virus disease 2019: A retrospective cohort study in a designated hospital of Wuhan in China. Clin Infect Dis. 2020 Mar 17. doi: 10.1093/cid/ciaa287.

5. Krein SL et al. Identification and characterization of failures in infectious agent transmission precaution practices in hospitals: A qualitative study. JAMA Intern Med. 2018;178(8):1016-57. doi: 10.1001/jamainternmed.2018.1898.

Kendra Boroff believes she contracted the coronavirus on her 71st birthday, Feb. 20, when her family went out for a celebratory dinner, perhaps from their waiter, who was coughing into his elbow. Four days later, she developed a fever and a raging sore throat.

“You feel like you’re suffocating,” recalled Boroff, a real estate agent in Maineville, Ohio. “You cough and breathe with the top fourth or maybe less of your chest, because everything else is in a vise.”

Over the course of the next 3 weeks, as Boroff started getting chills and nausea, a series of doctors would suggest that it could be the common cold, bronchitis or pneumonia. She tested negative for the flu, and her chest x-rays showed signs of lung damage, including white patches called “ground-glass opacities” that are common in COVID-19 cases. By March 7, she was pretty sure it was COVID-19, but she couldn’t get a test until she arrived at the emergency room at the University of Cincinnati Health Center on March 19. She had a 103 degree fever and her oxygen levels were plummeting, so the doctors admitted her immediately.

Nearly a week later, as Boroff’s condition was stabilizing, the test results came back: negative.

Boroff was flummoxed, but her physician was clear that she had the virus, no matter what her test said.

“ ‘This is my diagnosis,’ ” she recalled him saying. “ ‘There is no other explanation.’ ”

Tests turning up negative even when all signs point to COVID-19 has been a common experience in American hospitals over the past month, public health experts have told ProPublica. It’s unclear what proportion of these negative results are inaccurate – known as “false negatives” – and whether that’s due to some external factor, like bad sample collection, or because of an issue inherent in the tests’ design.

Neither the major test manufacturers, the U.S. Food and Drug Administration, or the U.S. Centers for Disease Control and Prevention would say how common false negatives are. While the FDA requires test makers to report any known instances of false negatives as a condition of granting them provisional approval, known as emergency use authorizations, no such reports are visible in a database the agency maintains for that purpose.

Without much data on how COVID-19 tests are performing in the real world, concerns are mounting that a lack of accurate testing will make it more difficult for America to relax social distancing, as the ability to track and trace new infections will be critical for any strategy to reopen the country.

Those warnings have reached Capitol Hill, where Texas Democratic Rep. Lloyd Doggett had heard from a doctor in his district about the accuracy of the tests. On Thursday, he and Rep. Rosa DeLauro of Connecticut sent a letter to the FDA demanding more data about the prevalence of false negatives in both the diagnostic tests currently in widespread use, as well as inaccuracies in the coming wave of rapid blood tests that detect immunity once the infection has passed.

“I’m very concerned about it,” Doggett told ProPublica. Too many false results, he worries, could lead to a new surge of infections when people go back to work or are allowed to gather in bars, sports arenas, and restaurants. “They have to monitor this very closely to ensure that we’re not creating false expectations, and in the process ending up with an epidemic that is even worse than the one we have now.”
 

Lowering the bar in an emergency

In the early days of the pandemic, the FDA, which regulates diagnostic tests, was criticized for not moving quickly enough to make testing widely available. For much of February, the only available test was the CDC’s, which initially had flaws when it was sent out to public health labs. Only on Feb. 29 did the FDA announce a new policy that made it easier for private labs and academic medical centers to make tests available as well.

Since then, the ongoing need for even more testing capacity across the United States has pushed the agency to loosen its typical requirements for manufacturers to prove that their tests are accurate before allowing them onto the market.

Normally, to get FDA approval, diagnostic makers need to run trials to gather evidence on their tests’ performance, a process that can take months or even years. The agency is currently skipping a lot of those steps by issuing emergency use authorizations.

Manufacturers are now required to run their COVID-19 tests on a minimum of 30 positive samples and 30 negative samples. They must demonstrate to the agency that the test has at least a 95% sensitivity, meaning it must correctly identify at least 95% of the positive samples as having the coronavirus, and 100% specificity, meaning that it must accurately identify all the negative samples as not having the coronavirus.

But the manufacturers are demonstrating their diagnostics’ performance with what’s known as “contrived samples,” which are not taken from actual patients. A contrived sample is made by taking coronavirus RNA made in a lab and putting it into a medium that mimics nasal mucus.

“This is supposed to represent a swab specimen, but it’s not a positive sample from a real patient, and that does make a real difference,” said Benjamin Pinsky, medical director of the Clinical Virology Laboratory for Stanford Health Care.

It’s not clear if the concentrations of virus on the simulated samples are representative of the full range of material taken from patients’ bodies in the real world. Pinksy says that it’s reasonable for the FDA to allow the use of contrived samples, because it makes it much faster for a manufacturer to run validation studies, and the need for speed has been pressing.

“But then we need to have studies to compare these assays and see how they perform with real-world samples, and whether some are more or less sensitive and whether some are more or less specific,” Pinsky said. “We don’t know the answer to these questions at this point.”

To compensate for the lower standard up front, experts say the FDA should track data on accuracy to make sure the tests are performing as expected, but this is easier said than done.

“In diagnostic tests in particular, it’s very difficult to know if something is failing,” said Alberto Gutierrez, former director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “When are you getting more erroneous results than you should? It’s not always easy to figure out.”

Swiss manufacturer Roche, whose test was authorized by the FDA on March 12, told ProPublica it couldn’t give specific numbers about its test’s actual rate of false negatives and false positives, though it said studies have demonstrated its test could detect very low levels of the coronavirus.

“Clinical studies, which take months to run and would be part of a regular (nonemergency) test approval process, are needed to give us an exact percentage of false negatives and false positives,” Roche spokesman Mike Weist wrote in an email. “We will continue to work with the FDA on ongoing studies post-EUA that will allow us to potentially say more in the future.”

Abbott, which makes a rapid COVID-19 test, also said that “performance characteristics, including accuracy data, will continue to be collected in the field.”

Abbott and the testing firms LabCorp and Quest Diagnostics all told ProPublica that tests should be used by physicians along with other information to form a diagnosis.
 

Even good tests can give inaccurate results

Clinicians and researchers said that a number of factors could cause inaccurate results on COVID-19 tests, and many of them have nothing to do with the test’s design.

For starters, the timing of when a patient receives the test matters. “If you’re far out from the initial exposure, the more days you are after onset, viral load goes down,” explained Stanford’s Pinsky. Viral load refers to the amount of virus that is being emitted from an infected person’s cells, and if that drops too low, even a person who still has an active infection may test negative.

Another issue is where the virus is in a person’s body. As the disease progresses, scientists think the virus tends to move down into a patient’s lungs, so the window of time when a nose swab will return a positive result may be limited.

“One of the issues with this stupid virus is that, if it’s down in your lungs, and we’re putting a swab up your nose, that’s not the best way to measure what’s in your lungs,” said Alex Greninger, assistant director of the clinical virology lab at the University of Washington Medical Center.

While it is possible to stick a scope down a patient’s airway to collect a sample from the bottom of the lungs, this is a much more complex procedure that requires sedating the patient. Technicians can ask a patient to cough up phlegm, known as sputum, but doing so substantially raises the risk of infecting health care workers. Even with a nasopharyngeal sample collected with a nose swab, one needs to collect it properly, which involves sticking the swab quite far up a patient’s nose.

Daniel Brook, a freelance journalist and historian in New Orleans, says he thinks his test result may have been a false negative because he was incorrectly swabbed.

During Mardi Gras, he hung out with a friend who was visiting from Manhattan. A few days later, as he started to get night sweats and chills, Brook’s friend texted to say that he had tested positive for COVID-19. Brook has asthma, so when he started to have trouble breathing, he went to an urgent care center, which said it didn’t have enough tests to give him one.

Four days later, as Brook found himself even more winded going up stairs, he and his girlfriend, who also had symptoms, received a letter from an emergency room doctor that would get them a test at a drive-through center. They first were tested for the flu and then finally for COVID-19.

“This flu test was way the hell in there. It was almost like you ate too much hot pepper,” Brook said. “And then we had this COVID test, and it was barely in the nose at all, which may be one of the issues.” Nine days later, they received their results: Both were negative.

Brook was confused. He had been trying to tell all of the people he had been in contact with, like his barber, that they might have been exposed, and he shared the good news with many of them. But his doctor told him that clinically, he had all the symptoms of COVID-19, and that his diagnosis would not change based on his test result.

Even if the sample is taken correctly, mishandling of the swab can also invalidate the result. RNA is similar to DNA but due to chemical differences is a much more fragile material and degrades more readily. This coronavirus is an RNA virus, essentially a string of RNA encased in a membrane “envelope.”

Abbott, one of the test makers, said that it recommends that samples be kept for no more than 8 hours at about 60-85 degrees Fahrenheit, or refrigerated for 72 hours. “People should make sure it is tested in a timely fashion,” Abbott said in its statement to ProPublica.

None of this bodes well for the numerous labs that have reported backlogs of tens of thousands of samples that are waiting to be tested.

A technician at an academic laboratory, who asked for anonymity because he is not authorized to speak on behalf of his university, described seeing basic mishandling of samples that is probably ruining dozens of patients’ test results.

“I don’t know why, but with COVID, we’ve just been awash with problems,” he told ProPublica. “Even simple things like caps not screwed on tightly – we’ll get a bag of samples, and two or three of them will be leaking, so you have this media completely soaking the inside of the bag. If one of those leaking samples is positive, you’ll have droplets all over the bag.”

Those samples, the technician said, often can’t be processed at all. His experience isn’t unique: In Alabama in late March, hundreds of samples were ruined in transit to a lab in Montgomery.
 

The dangers of inaccuracy

In the absence of data, physicians and public health officials are left to guess how many false negatives may be occurring – which could have serious consequences both for individuals and for combating the spread of the disease.

“You want to be right every time, because you miss somebody, and tell them that they’re negative, then you’re infecting people,” said Gutierrez, the former FDA official. “Let’s say you consider Amazon essential, and at the warehouse they’re testing people, even if they miss 1 or 5 people out of 100, that can be problematic.”

In addition, false negatives can make it more difficult to track spread of the virus, since those patients are not reported as confirmed cases and people who die without a positive test result won’t be counted in COVID-19 mortality statistics.

False positives also present problems. If you mistakenly think a patient has COVID-19, “then you have the potential to clog up the health care system and waste personal protective equipment and the time and effort of health care workers who think they are caring for individuals with COVID-19,” Stanford’s Pinsky said. “In addition, you’re producing a lot of anxiety for the patient.”

Pinsky says he hopes that real-world data will be gathered on the tests’ performance, especially as more and more come on the market: “If physicians have this information, they could move on to a different, better performing test and use that instead.”

Dr. Yukari Manabe, associate director of Global Health Research and Innovation at Johns Hopkins Medicine, estimates that 10%-25% of test results are false negatives. That’s not based on any data, she cautions, since hard evidence isn’t available. But she has been noticing many patients in the Hopkins system being tested more than once, when the first result doesn’t match their clinical symptoms.

Like others, Manabe acknowledges that the FDA has needed to greenlight tests quickly in order to get them out into the public. But she laments that companies weren’t encouraged to develop diagnostics earlier, which might have allowed the agency to keep the bar for approval higher, and also churn out more tests sooner.

“If people had seen the writing on the wall back in December, someone should’ve paid these companies what they needed to develop these tests on platforms that could’ve been rapidly ramped up to millions of tests,” Manabe said.

Instead, a test shortage caused doctors to limit tests to only the sickest patients, at a time when the virus had probably moved out of the back of the nasal cavity and into their lungs. A larger supply would have allowed for testing more people as soon as they started showing symptoms. That would have resulted in a lower rate of false negatives, Manabe said, since nose swabs are more likely to detect the virus soon after it’s been contracted.
 

The next wave of tests may be even less accurate

The questions swirling around the accuracy of the COVID-19 diagnostic tests are likely to persist as the next set of tests – antibody blood tests – start hitting the market. Already, the FDA has authorized the first of these tests, which search for molecules in a patient’s blood that can indicate if the immune system did battle with the coronavirus. Unlike the swab-based tests, which look for the viral RNA that indicate active infection, antibody tests are used to seek evidence of a past encounter with the virus.

Antibody tests are already seen as a critical tool in lifting lock-down measures, because they could potentially be used to figure out who has immunity to the coronavirus. In this case, false positives would be the greater concern, because it could be dangerous to tell someone that they have antibodies and are safe to go back to work when that is a false signal.

There are issues that need to be figured out before rushing to rely on these tests, Stanford’s Pinsky warned. What level of antibodies are needed to mean that someone is protected? And if you are protected, how long are you protected? The answers to these basic questions are still unknown, he said. This week, the World Health Organization put out guidance recommending against using antibody tests for clinical decision making.

The FDA, meanwhile, is lowering the bar even further. On March 16, it issued new guidance allowing manufacturers to distribute tests even before receiving emergency use authorization, for a “reasonable period of time” – about 15 days – after a diagnostic maker had validated the test internally and while preparing its request to the agency for an EUA.

Local governments are desperate enough for tests that they’ll buy them without assurances of accuracy at all. Chicago recently ordered 11,000 antibody tests made in South Korea that had not been reviewed by the FDA but are legal to distribute as long as they include several disclaimers including a recommendation that any negative result be confirmed with a diagnostic test.

“There’s no time really to put the effort into saying, ’Where’s the problem here?’ ” said Catherine Troisi, an epidemiologist at the University of Texas Health Science Center. “I’m not saying the test is bad. But what good is a test if you don’t know it’s giving you reliable results? We just don’t know.”

Correction, April 10, 2020: This story originally said incorrectly that Kendra Boroff was admitted to an intensive care unit.

This article was first published on ProPublica.com.

Kendra Boroff believes she contracted the coronavirus on her 71st birthday, Feb. 20, when her family went out for a celebratory dinner, perhaps from their waiter, who was coughing into his elbow. Four days later, she developed a fever and a raging sore throat.

“You feel like you’re suffocating,” recalled Boroff, a real estate agent in Maineville, Ohio. “You cough and breathe with the top fourth or maybe less of your chest, because everything else is in a vise.”

Over the course of the next 3 weeks, as Boroff started getting chills and nausea, a series of doctors would suggest that it could be the common cold, bronchitis or pneumonia. She tested negative for the flu, and her chest x-rays showed signs of lung damage, including white patches called “ground-glass opacities” that are common in COVID-19 cases. By March 7, she was pretty sure it was COVID-19, but she couldn’t get a test until she arrived at the emergency room at the University of Cincinnati Health Center on March 19. She had a 103 degree fever and her oxygen levels were plummeting, so the doctors admitted her immediately.

Nearly a week later, as Boroff’s condition was stabilizing, the test results came back: negative.

Boroff was flummoxed, but her physician was clear that she had the virus, no matter what her test said.

“ ‘This is my diagnosis,’ ” she recalled him saying. “ ‘There is no other explanation.’ ”

Tests turning up negative even when all signs point to COVID-19 has been a common experience in American hospitals over the past month, public health experts have told ProPublica. It’s unclear what proportion of these negative results are inaccurate – known as “false negatives” – and whether that’s due to some external factor, like bad sample collection, or because of an issue inherent in the tests’ design.

Neither the major test manufacturers, the U.S. Food and Drug Administration, or the U.S. Centers for Disease Control and Prevention would say how common false negatives are. While the FDA requires test makers to report any known instances of false negatives as a condition of granting them provisional approval, known as emergency use authorizations, no such reports are visible in a database the agency maintains for that purpose.

Without much data on how COVID-19 tests are performing in the real world, concerns are mounting that a lack of accurate testing will make it more difficult for America to relax social distancing, as the ability to track and trace new infections will be critical for any strategy to reopen the country.

Those warnings have reached Capitol Hill, where Texas Democratic Rep. Lloyd Doggett had heard from a doctor in his district about the accuracy of the tests. On Thursday, he and Rep. Rosa DeLauro of Connecticut sent a letter to the FDA demanding more data about the prevalence of false negatives in both the diagnostic tests currently in widespread use, as well as inaccuracies in the coming wave of rapid blood tests that detect immunity once the infection has passed.

“I’m very concerned about it,” Doggett told ProPublica. Too many false results, he worries, could lead to a new surge of infections when people go back to work or are allowed to gather in bars, sports arenas, and restaurants. “They have to monitor this very closely to ensure that we’re not creating false expectations, and in the process ending up with an epidemic that is even worse than the one we have now.”
 

Lowering the bar in an emergency

In the early days of the pandemic, the FDA, which regulates diagnostic tests, was criticized for not moving quickly enough to make testing widely available. For much of February, the only available test was the CDC’s, which initially had flaws when it was sent out to public health labs. Only on Feb. 29 did the FDA announce a new policy that made it easier for private labs and academic medical centers to make tests available as well.

Since then, the ongoing need for even more testing capacity across the United States has pushed the agency to loosen its typical requirements for manufacturers to prove that their tests are accurate before allowing them onto the market.

Normally, to get FDA approval, diagnostic makers need to run trials to gather evidence on their tests’ performance, a process that can take months or even years. The agency is currently skipping a lot of those steps by issuing emergency use authorizations.

Manufacturers are now required to run their COVID-19 tests on a minimum of 30 positive samples and 30 negative samples. They must demonstrate to the agency that the test has at least a 95% sensitivity, meaning it must correctly identify at least 95% of the positive samples as having the coronavirus, and 100% specificity, meaning that it must accurately identify all the negative samples as not having the coronavirus.

But the manufacturers are demonstrating their diagnostics’ performance with what’s known as “contrived samples,” which are not taken from actual patients. A contrived sample is made by taking coronavirus RNA made in a lab and putting it into a medium that mimics nasal mucus.

“This is supposed to represent a swab specimen, but it’s not a positive sample from a real patient, and that does make a real difference,” said Benjamin Pinsky, medical director of the Clinical Virology Laboratory for Stanford Health Care.

It’s not clear if the concentrations of virus on the simulated samples are representative of the full range of material taken from patients’ bodies in the real world. Pinksy says that it’s reasonable for the FDA to allow the use of contrived samples, because it makes it much faster for a manufacturer to run validation studies, and the need for speed has been pressing.

“But then we need to have studies to compare these assays and see how they perform with real-world samples, and whether some are more or less sensitive and whether some are more or less specific,” Pinsky said. “We don’t know the answer to these questions at this point.”

To compensate for the lower standard up front, experts say the FDA should track data on accuracy to make sure the tests are performing as expected, but this is easier said than done.

“In diagnostic tests in particular, it’s very difficult to know if something is failing,” said Alberto Gutierrez, former director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “When are you getting more erroneous results than you should? It’s not always easy to figure out.”

Swiss manufacturer Roche, whose test was authorized by the FDA on March 12, told ProPublica it couldn’t give specific numbers about its test’s actual rate of false negatives and false positives, though it said studies have demonstrated its test could detect very low levels of the coronavirus.

“Clinical studies, which take months to run and would be part of a regular (nonemergency) test approval process, are needed to give us an exact percentage of false negatives and false positives,” Roche spokesman Mike Weist wrote in an email. “We will continue to work with the FDA on ongoing studies post-EUA that will allow us to potentially say more in the future.”

Abbott, which makes a rapid COVID-19 test, also said that “performance characteristics, including accuracy data, will continue to be collected in the field.”

Abbott and the testing firms LabCorp and Quest Diagnostics all told ProPublica that tests should be used by physicians along with other information to form a diagnosis.
 

Even good tests can give inaccurate results

Clinicians and researchers said that a number of factors could cause inaccurate results on COVID-19 tests, and many of them have nothing to do with the test’s design.

For starters, the timing of when a patient receives the test matters. “If you’re far out from the initial exposure, the more days you are after onset, viral load goes down,” explained Stanford’s Pinsky. Viral load refers to the amount of virus that is being emitted from an infected person’s cells, and if that drops too low, even a person who still has an active infection may test negative.

Another issue is where the virus is in a person’s body. As the disease progresses, scientists think the virus tends to move down into a patient’s lungs, so the window of time when a nose swab will return a positive result may be limited.

“One of the issues with this stupid virus is that, if it’s down in your lungs, and we’re putting a swab up your nose, that’s not the best way to measure what’s in your lungs,” said Alex Greninger, assistant director of the clinical virology lab at the University of Washington Medical Center.

While it is possible to stick a scope down a patient’s airway to collect a sample from the bottom of the lungs, this is a much more complex procedure that requires sedating the patient. Technicians can ask a patient to cough up phlegm, known as sputum, but doing so substantially raises the risk of infecting health care workers. Even with a nasopharyngeal sample collected with a nose swab, one needs to collect it properly, which involves sticking the swab quite far up a patient’s nose.

Daniel Brook, a freelance journalist and historian in New Orleans, says he thinks his test result may have been a false negative because he was incorrectly swabbed.

During Mardi Gras, he hung out with a friend who was visiting from Manhattan. A few days later, as he started to get night sweats and chills, Brook’s friend texted to say that he had tested positive for COVID-19. Brook has asthma, so when he started to have trouble breathing, he went to an urgent care center, which said it didn’t have enough tests to give him one.

Four days later, as Brook found himself even more winded going up stairs, he and his girlfriend, who also had symptoms, received a letter from an emergency room doctor that would get them a test at a drive-through center. They first were tested for the flu and then finally for COVID-19.

“This flu test was way the hell in there. It was almost like you ate too much hot pepper,” Brook said. “And then we had this COVID test, and it was barely in the nose at all, which may be one of the issues.” Nine days later, they received their results: Both were negative.

Brook was confused. He had been trying to tell all of the people he had been in contact with, like his barber, that they might have been exposed, and he shared the good news with many of them. But his doctor told him that clinically, he had all the symptoms of COVID-19, and that his diagnosis would not change based on his test result.

Even if the sample is taken correctly, mishandling of the swab can also invalidate the result. RNA is similar to DNA but due to chemical differences is a much more fragile material and degrades more readily. This coronavirus is an RNA virus, essentially a string of RNA encased in a membrane “envelope.”

Abbott, one of the test makers, said that it recommends that samples be kept for no more than 8 hours at about 60-85 degrees Fahrenheit, or refrigerated for 72 hours. “People should make sure it is tested in a timely fashion,” Abbott said in its statement to ProPublica.

None of this bodes well for the numerous labs that have reported backlogs of tens of thousands of samples that are waiting to be tested.

A technician at an academic laboratory, who asked for anonymity because he is not authorized to speak on behalf of his university, described seeing basic mishandling of samples that is probably ruining dozens of patients’ test results.

“I don’t know why, but with COVID, we’ve just been awash with problems,” he told ProPublica. “Even simple things like caps not screwed on tightly – we’ll get a bag of samples, and two or three of them will be leaking, so you have this media completely soaking the inside of the bag. If one of those leaking samples is positive, you’ll have droplets all over the bag.”

Those samples, the technician said, often can’t be processed at all. His experience isn’t unique: In Alabama in late March, hundreds of samples were ruined in transit to a lab in Montgomery.
 

The dangers of inaccuracy

In the absence of data, physicians and public health officials are left to guess how many false negatives may be occurring – which could have serious consequences both for individuals and for combating the spread of the disease.

“You want to be right every time, because you miss somebody, and tell them that they’re negative, then you’re infecting people,” said Gutierrez, the former FDA official. “Let’s say you consider Amazon essential, and at the warehouse they’re testing people, even if they miss 1 or 5 people out of 100, that can be problematic.”

In addition, false negatives can make it more difficult to track spread of the virus, since those patients are not reported as confirmed cases and people who die without a positive test result won’t be counted in COVID-19 mortality statistics.

False positives also present problems. If you mistakenly think a patient has COVID-19, “then you have the potential to clog up the health care system and waste personal protective equipment and the time and effort of health care workers who think they are caring for individuals with COVID-19,” Stanford’s Pinsky said. “In addition, you’re producing a lot of anxiety for the patient.”

Pinsky says he hopes that real-world data will be gathered on the tests’ performance, especially as more and more come on the market: “If physicians have this information, they could move on to a different, better performing test and use that instead.”

Dr. Yukari Manabe, associate director of Global Health Research and Innovation at Johns Hopkins Medicine, estimates that 10%-25% of test results are false negatives. That’s not based on any data, she cautions, since hard evidence isn’t available. But she has been noticing many patients in the Hopkins system being tested more than once, when the first result doesn’t match their clinical symptoms.

Like others, Manabe acknowledges that the FDA has needed to greenlight tests quickly in order to get them out into the public. But she laments that companies weren’t encouraged to develop diagnostics earlier, which might have allowed the agency to keep the bar for approval higher, and also churn out more tests sooner.

“If people had seen the writing on the wall back in December, someone should’ve paid these companies what they needed to develop these tests on platforms that could’ve been rapidly ramped up to millions of tests,” Manabe said.

Instead, a test shortage caused doctors to limit tests to only the sickest patients, at a time when the virus had probably moved out of the back of the nasal cavity and into their lungs. A larger supply would have allowed for testing more people as soon as they started showing symptoms. That would have resulted in a lower rate of false negatives, Manabe said, since nose swabs are more likely to detect the virus soon after it’s been contracted.
 

The next wave of tests may be even less accurate

The questions swirling around the accuracy of the COVID-19 diagnostic tests are likely to persist as the next set of tests – antibody blood tests – start hitting the market. Already, the FDA has authorized the first of these tests, which search for molecules in a patient’s blood that can indicate if the immune system did battle with the coronavirus. Unlike the swab-based tests, which look for the viral RNA that indicate active infection, antibody tests are used to seek evidence of a past encounter with the virus.

Antibody tests are already seen as a critical tool in lifting lock-down measures, because they could potentially be used to figure out who has immunity to the coronavirus. In this case, false positives would be the greater concern, because it could be dangerous to tell someone that they have antibodies and are safe to go back to work when that is a false signal.

There are issues that need to be figured out before rushing to rely on these tests, Stanford’s Pinsky warned. What level of antibodies are needed to mean that someone is protected? And if you are protected, how long are you protected? The answers to these basic questions are still unknown, he said. This week, the World Health Organization put out guidance recommending against using antibody tests for clinical decision making.

The FDA, meanwhile, is lowering the bar even further. On March 16, it issued new guidance allowing manufacturers to distribute tests even before receiving emergency use authorization, for a “reasonable period of time” – about 15 days – after a diagnostic maker had validated the test internally and while preparing its request to the agency for an EUA.

Local governments are desperate enough for tests that they’ll buy them without assurances of accuracy at all. Chicago recently ordered 11,000 antibody tests made in South Korea that had not been reviewed by the FDA but are legal to distribute as long as they include several disclaimers including a recommendation that any negative result be confirmed with a diagnostic test.

“There’s no time really to put the effort into saying, ’Where’s the problem here?’ ” said Catherine Troisi, an epidemiologist at the University of Texas Health Science Center. “I’m not saying the test is bad. But what good is a test if you don’t know it’s giving you reliable results? We just don’t know.”

Correction, April 10, 2020: This story originally said incorrectly that Kendra Boroff was admitted to an intensive care unit.

This article was first published on ProPublica.com.

Kendra Boroff believes she contracted the coronavirus on her 71st birthday, Feb. 20, when her family went out for a celebratory dinner, perhaps from their waiter, who was coughing into his elbow. Four days later, she developed a fever and a raging sore throat.

“You feel like you’re suffocating,” recalled Boroff, a real estate agent in Maineville, Ohio. “You cough and breathe with the top fourth or maybe less of your chest, because everything else is in a vise.”

Over the course of the next 3 weeks, as Boroff started getting chills and nausea, a series of doctors would suggest that it could be the common cold, bronchitis or pneumonia. She tested negative for the flu, and her chest x-rays showed signs of lung damage, including white patches called “ground-glass opacities” that are common in COVID-19 cases. By March 7, she was pretty sure it was COVID-19, but she couldn’t get a test until she arrived at the emergency room at the University of Cincinnati Health Center on March 19. She had a 103 degree fever and her oxygen levels were plummeting, so the doctors admitted her immediately.

Nearly a week later, as Boroff’s condition was stabilizing, the test results came back: negative.

Boroff was flummoxed, but her physician was clear that she had the virus, no matter what her test said.

“ ‘This is my diagnosis,’ ” she recalled him saying. “ ‘There is no other explanation.’ ”

Tests turning up negative even when all signs point to COVID-19 has been a common experience in American hospitals over the past month, public health experts have told ProPublica. It’s unclear what proportion of these negative results are inaccurate – known as “false negatives” – and whether that’s due to some external factor, like bad sample collection, or because of an issue inherent in the tests’ design.

Neither the major test manufacturers, the U.S. Food and Drug Administration, or the U.S. Centers for Disease Control and Prevention would say how common false negatives are. While the FDA requires test makers to report any known instances of false negatives as a condition of granting them provisional approval, known as emergency use authorizations, no such reports are visible in a database the agency maintains for that purpose.

Without much data on how COVID-19 tests are performing in the real world, concerns are mounting that a lack of accurate testing will make it more difficult for America to relax social distancing, as the ability to track and trace new infections will be critical for any strategy to reopen the country.

Those warnings have reached Capitol Hill, where Texas Democratic Rep. Lloyd Doggett had heard from a doctor in his district about the accuracy of the tests. On Thursday, he and Rep. Rosa DeLauro of Connecticut sent a letter to the FDA demanding more data about the prevalence of false negatives in both the diagnostic tests currently in widespread use, as well as inaccuracies in the coming wave of rapid blood tests that detect immunity once the infection has passed.

“I’m very concerned about it,” Doggett told ProPublica. Too many false results, he worries, could lead to a new surge of infections when people go back to work or are allowed to gather in bars, sports arenas, and restaurants. “They have to monitor this very closely to ensure that we’re not creating false expectations, and in the process ending up with an epidemic that is even worse than the one we have now.”
 

Lowering the bar in an emergency

In the early days of the pandemic, the FDA, which regulates diagnostic tests, was criticized for not moving quickly enough to make testing widely available. For much of February, the only available test was the CDC’s, which initially had flaws when it was sent out to public health labs. Only on Feb. 29 did the FDA announce a new policy that made it easier for private labs and academic medical centers to make tests available as well.

Since then, the ongoing need for even more testing capacity across the United States has pushed the agency to loosen its typical requirements for manufacturers to prove that their tests are accurate before allowing them onto the market.

Normally, to get FDA approval, diagnostic makers need to run trials to gather evidence on their tests’ performance, a process that can take months or even years. The agency is currently skipping a lot of those steps by issuing emergency use authorizations.

Manufacturers are now required to run their COVID-19 tests on a minimum of 30 positive samples and 30 negative samples. They must demonstrate to the agency that the test has at least a 95% sensitivity, meaning it must correctly identify at least 95% of the positive samples as having the coronavirus, and 100% specificity, meaning that it must accurately identify all the negative samples as not having the coronavirus.

But the manufacturers are demonstrating their diagnostics’ performance with what’s known as “contrived samples,” which are not taken from actual patients. A contrived sample is made by taking coronavirus RNA made in a lab and putting it into a medium that mimics nasal mucus.

“This is supposed to represent a swab specimen, but it’s not a positive sample from a real patient, and that does make a real difference,” said Benjamin Pinsky, medical director of the Clinical Virology Laboratory for Stanford Health Care.

It’s not clear if the concentrations of virus on the simulated samples are representative of the full range of material taken from patients’ bodies in the real world. Pinksy says that it’s reasonable for the FDA to allow the use of contrived samples, because it makes it much faster for a manufacturer to run validation studies, and the need for speed has been pressing.

“But then we need to have studies to compare these assays and see how they perform with real-world samples, and whether some are more or less sensitive and whether some are more or less specific,” Pinsky said. “We don’t know the answer to these questions at this point.”

To compensate for the lower standard up front, experts say the FDA should track data on accuracy to make sure the tests are performing as expected, but this is easier said than done.

“In diagnostic tests in particular, it’s very difficult to know if something is failing,” said Alberto Gutierrez, former director of the FDA’s Office of In Vitro Diagnostics and Radiological Health. “When are you getting more erroneous results than you should? It’s not always easy to figure out.”

Swiss manufacturer Roche, whose test was authorized by the FDA on March 12, told ProPublica it couldn’t give specific numbers about its test’s actual rate of false negatives and false positives, though it said studies have demonstrated its test could detect very low levels of the coronavirus.

“Clinical studies, which take months to run and would be part of a regular (nonemergency) test approval process, are needed to give us an exact percentage of false negatives and false positives,” Roche spokesman Mike Weist wrote in an email. “We will continue to work with the FDA on ongoing studies post-EUA that will allow us to potentially say more in the future.”

Abbott, which makes a rapid COVID-19 test, also said that “performance characteristics, including accuracy data, will continue to be collected in the field.”

Abbott and the testing firms LabCorp and Quest Diagnostics all told ProPublica that tests should be used by physicians along with other information to form a diagnosis.
 

Even good tests can give inaccurate results

Clinicians and researchers said that a number of factors could cause inaccurate results on COVID-19 tests, and many of them have nothing to do with the test’s design.

For starters, the timing of when a patient receives the test matters. “If you’re far out from the initial exposure, the more days you are after onset, viral load goes down,” explained Stanford’s Pinsky. Viral load refers to the amount of virus that is being emitted from an infected person’s cells, and if that drops too low, even a person who still has an active infection may test negative.

Another issue is where the virus is in a person’s body. As the disease progresses, scientists think the virus tends to move down into a patient’s lungs, so the window of time when a nose swab will return a positive result may be limited.

“One of the issues with this stupid virus is that, if it’s down in your lungs, and we’re putting a swab up your nose, that’s not the best way to measure what’s in your lungs,” said Alex Greninger, assistant director of the clinical virology lab at the University of Washington Medical Center.

While it is possible to stick a scope down a patient’s airway to collect a sample from the bottom of the lungs, this is a much more complex procedure that requires sedating the patient. Technicians can ask a patient to cough up phlegm, known as sputum, but doing so substantially raises the risk of infecting health care workers. Even with a nasopharyngeal sample collected with a nose swab, one needs to collect it properly, which involves sticking the swab quite far up a patient’s nose.

Daniel Brook, a freelance journalist and historian in New Orleans, says he thinks his test result may have been a false negative because he was incorrectly swabbed.

During Mardi Gras, he hung out with a friend who was visiting from Manhattan. A few days later, as he started to get night sweats and chills, Brook’s friend texted to say that he had tested positive for COVID-19. Brook has asthma, so when he started to have trouble breathing, he went to an urgent care center, which said it didn’t have enough tests to give him one.

Four days later, as Brook found himself even more winded going up stairs, he and his girlfriend, who also had symptoms, received a letter from an emergency room doctor that would get them a test at a drive-through center. They first were tested for the flu and then finally for COVID-19.

“This flu test was way the hell in there. It was almost like you ate too much hot pepper,” Brook said. “And then we had this COVID test, and it was barely in the nose at all, which may be one of the issues.” Nine days later, they received their results: Both were negative.

Brook was confused. He had been trying to tell all of the people he had been in contact with, like his barber, that they might have been exposed, and he shared the good news with many of them. But his doctor told him that clinically, he had all the symptoms of COVID-19, and that his diagnosis would not change based on his test result.

Even if the sample is taken correctly, mishandling of the swab can also invalidate the result. RNA is similar to DNA but due to chemical differences is a much more fragile material and degrades more readily. This coronavirus is an RNA virus, essentially a string of RNA encased in a membrane “envelope.”

Abbott, one of the test makers, said that it recommends that samples be kept for no more than 8 hours at about 60-85 degrees Fahrenheit, or refrigerated for 72 hours. “People should make sure it is tested in a timely fashion,” Abbott said in its statement to ProPublica.

None of this bodes well for the numerous labs that have reported backlogs of tens of thousands of samples that are waiting to be tested.

A technician at an academic laboratory, who asked for anonymity because he is not authorized to speak on behalf of his university, described seeing basic mishandling of samples that is probably ruining dozens of patients’ test results.

“I don’t know why, but with COVID, we’ve just been awash with problems,” he told ProPublica. “Even simple things like caps not screwed on tightly – we’ll get a bag of samples, and two or three of them will be leaking, so you have this media completely soaking the inside of the bag. If one of those leaking samples is positive, you’ll have droplets all over the bag.”

Those samples, the technician said, often can’t be processed at all. His experience isn’t unique: In Alabama in late March, hundreds of samples were ruined in transit to a lab in Montgomery.
 

The dangers of inaccuracy

In the absence of data, physicians and public health officials are left to guess how many false negatives may be occurring – which could have serious consequences both for individuals and for combating the spread of the disease.

“You want to be right every time, because you miss somebody, and tell them that they’re negative, then you’re infecting people,” said Gutierrez, the former FDA official. “Let’s say you consider Amazon essential, and at the warehouse they’re testing people, even if they miss 1 or 5 people out of 100, that can be problematic.”

In addition, false negatives can make it more difficult to track spread of the virus, since those patients are not reported as confirmed cases and people who die without a positive test result won’t be counted in COVID-19 mortality statistics.

False positives also present problems. If you mistakenly think a patient has COVID-19, “then you have the potential to clog up the health care system and waste personal protective equipment and the time and effort of health care workers who think they are caring for individuals with COVID-19,” Stanford’s Pinsky said. “In addition, you’re producing a lot of anxiety for the patient.”

Pinsky says he hopes that real-world data will be gathered on the tests’ performance, especially as more and more come on the market: “If physicians have this information, they could move on to a different, better performing test and use that instead.”

Dr. Yukari Manabe, associate director of Global Health Research and Innovation at Johns Hopkins Medicine, estimates that 10%-25% of test results are false negatives. That’s not based on any data, she cautions, since hard evidence isn’t available. But she has been noticing many patients in the Hopkins system being tested more than once, when the first result doesn’t match their clinical symptoms.

Like others, Manabe acknowledges that the FDA has needed to greenlight tests quickly in order to get them out into the public. But she laments that companies weren’t encouraged to develop diagnostics earlier, which might have allowed the agency to keep the bar for approval higher, and also churn out more tests sooner.

“If people had seen the writing on the wall back in December, someone should’ve paid these companies what they needed to develop these tests on platforms that could’ve been rapidly ramped up to millions of tests,” Manabe said.

Instead, a test shortage caused doctors to limit tests to only the sickest patients, at a time when the virus had probably moved out of the back of the nasal cavity and into their lungs. A larger supply would have allowed for testing more people as soon as they started showing symptoms. That would have resulted in a lower rate of false negatives, Manabe said, since nose swabs are more likely to detect the virus soon after it’s been contracted.
 

The next wave of tests may be even less accurate

The questions swirling around the accuracy of the COVID-19 diagnostic tests are likely to persist as the next set of tests – antibody blood tests – start hitting the market. Already, the FDA has authorized the first of these tests, which search for molecules in a patient’s blood that can indicate if the immune system did battle with the coronavirus. Unlike the swab-based tests, which look for the viral RNA that indicate active infection, antibody tests are used to seek evidence of a past encounter with the virus.

Antibody tests are already seen as a critical tool in lifting lock-down measures, because they could potentially be used to figure out who has immunity to the coronavirus. In this case, false positives would be the greater concern, because it could be dangerous to tell someone that they have antibodies and are safe to go back to work when that is a false signal.

There are issues that need to be figured out before rushing to rely on these tests, Stanford’s Pinsky warned. What level of antibodies are needed to mean that someone is protected? And if you are protected, how long are you protected? The answers to these basic questions are still unknown, he said. This week, the World Health Organization put out guidance recommending against using antibody tests for clinical decision making.

The FDA, meanwhile, is lowering the bar even further. On March 16, it issued new guidance allowing manufacturers to distribute tests even before receiving emergency use authorization, for a “reasonable period of time” – about 15 days – after a diagnostic maker had validated the test internally and while preparing its request to the agency for an EUA.

Local governments are desperate enough for tests that they’ll buy them without assurances of accuracy at all. Chicago recently ordered 11,000 antibody tests made in South Korea that had not been reviewed by the FDA but are legal to distribute as long as they include several disclaimers including a recommendation that any negative result be confirmed with a diagnostic test.

“There’s no time really to put the effort into saying, ’Where’s the problem here?’ ” said Catherine Troisi, an epidemiologist at the University of Texas Health Science Center. “I’m not saying the test is bad. But what good is a test if you don’t know it’s giving you reliable results? We just don’t know.”

Correction, April 10, 2020: This story originally said incorrectly that Kendra Boroff was admitted to an intensive care unit.

This article was first published on ProPublica.com.

An early report pegged the prevalence of cancer among COVID-19 patients at 1%, but authors of a recent meta-analysis found an overall prevalence of 2% and up to 3% depending on the subset of data they reviewed.

However, those findings are limited by the retrospective nature of the studies published to date, according to the authors of the meta-analysis, led by Aakash Desai, MBBS, of the University of Connecticut, Farmington.

Nevertheless, the results do confirm that cancer patients and survivors are an important at-risk population for COVID-19, according to Dr. Desai and colleagues.

“We hope that additional data from China and Italy will provide information on the characteristics of patients with cancer at risk, types of cancer that confer higher risk, and systemic regimens that may increase COVID-19 infection complications,” the authors wrote in JCO Global Oncology.

More than 15 million individuals with cancer and many more cancer survivors are at increased risk of COVID-19 because of compromised immune systems, according to the authors.

Exactly how many individuals with cancer are among the COVID-19 cases remains unclear, though a previous report suggested the prevalence of cancer was 1% (95% confidence interval, 0.61%-1.65%) among COVID-19 patients in China (Lancet Oncol. 2020 Mar;21[3]:335-7). This “seems to be higher” than the 0.29% prevalence of cancer in the overall Chinese population, the investigators noted at the time.

That study revealed 18 cancer patients among 1,590 COVID-19 cases, though it was “hypothesis generating,” according to Dr. Desai and colleagues, who rolled that data into their meta-analysis of 11 reports including 3,661 COVID-19 cases.

Overall, Dr. Desai and colleagues found the pooled prevalence of cancer was 2.0% (95% CI, 2.0%-3.0%) in that population. In a subgroup analysis of five studies with sample sizes of less than 100 COVID-19 patients, the researchers found a “slightly higher” prevalence of 3.0% (95% CI, 1.0%-6.0%).

However, even that data wasn’t robust enough for Dr. Desai and colleagues to make any pronouncements on cancer prevalence. “Overall, current evidence on the association between cancer and COVID-19 remains inconclusive,” they wrote.

Though inconclusive, the findings raise questions about whether treatments or interventions might need to be postponed in certain patients, whether cancer patients and survivors need stronger personal protection, and how to deal with potential delays in cancer clinical trials, according to Dr. Desai and colleagues.

“As the evidence continues to rise, we must strive to answer the unanswered clinical questions,” the authors wrote.

Dr. Desai and colleagues reported no potential conflicts of interest related to the study.

SOURCE: Desai A et al. JCO Glob Oncol. 2020 Apr 6. doi: 10.1200/GO.20.00097.

An early report pegged the prevalence of cancer among COVID-19 patients at 1%, but authors of a recent meta-analysis found an overall prevalence of 2% and up to 3% depending on the subset of data they reviewed.

However, those findings are limited by the retrospective nature of the studies published to date, according to the authors of the meta-analysis, led by Aakash Desai, MBBS, of the University of Connecticut, Farmington.

Nevertheless, the results do confirm that cancer patients and survivors are an important at-risk population for COVID-19, according to Dr. Desai and colleagues.

“We hope that additional data from China and Italy will provide information on the characteristics of patients with cancer at risk, types of cancer that confer higher risk, and systemic regimens that may increase COVID-19 infection complications,” the authors wrote in JCO Global Oncology.

More than 15 million individuals with cancer and many more cancer survivors are at increased risk of COVID-19 because of compromised immune systems, according to the authors.

Exactly how many individuals with cancer are among the COVID-19 cases remains unclear, though a previous report suggested the prevalence of cancer was 1% (95% confidence interval, 0.61%-1.65%) among COVID-19 patients in China (Lancet Oncol. 2020 Mar;21[3]:335-7). This “seems to be higher” than the 0.29% prevalence of cancer in the overall Chinese population, the investigators noted at the time.

That study revealed 18 cancer patients among 1,590 COVID-19 cases, though it was “hypothesis generating,” according to Dr. Desai and colleagues, who rolled that data into their meta-analysis of 11 reports including 3,661 COVID-19 cases.

Overall, Dr. Desai and colleagues found the pooled prevalence of cancer was 2.0% (95% CI, 2.0%-3.0%) in that population. In a subgroup analysis of five studies with sample sizes of less than 100 COVID-19 patients, the researchers found a “slightly higher” prevalence of 3.0% (95% CI, 1.0%-6.0%).

However, even that data wasn’t robust enough for Dr. Desai and colleagues to make any pronouncements on cancer prevalence. “Overall, current evidence on the association between cancer and COVID-19 remains inconclusive,” they wrote.

Though inconclusive, the findings raise questions about whether treatments or interventions might need to be postponed in certain patients, whether cancer patients and survivors need stronger personal protection, and how to deal with potential delays in cancer clinical trials, according to Dr. Desai and colleagues.

“As the evidence continues to rise, we must strive to answer the unanswered clinical questions,” the authors wrote.

Dr. Desai and colleagues reported no potential conflicts of interest related to the study.

SOURCE: Desai A et al. JCO Glob Oncol. 2020 Apr 6. doi: 10.1200/GO.20.00097.

An early report pegged the prevalence of cancer among COVID-19 patients at 1%, but authors of a recent meta-analysis found an overall prevalence of 2% and up to 3% depending on the subset of data they reviewed.

However, those findings are limited by the retrospective nature of the studies published to date, according to the authors of the meta-analysis, led by Aakash Desai, MBBS, of the University of Connecticut, Farmington.

Nevertheless, the results do confirm that cancer patients and survivors are an important at-risk population for COVID-19, according to Dr. Desai and colleagues.

“We hope that additional data from China and Italy will provide information on the characteristics of patients with cancer at risk, types of cancer that confer higher risk, and systemic regimens that may increase COVID-19 infection complications,” the authors wrote in JCO Global Oncology.

More than 15 million individuals with cancer and many more cancer survivors are at increased risk of COVID-19 because of compromised immune systems, according to the authors.

Exactly how many individuals with cancer are among the COVID-19 cases remains unclear, though a previous report suggested the prevalence of cancer was 1% (95% confidence interval, 0.61%-1.65%) among COVID-19 patients in China (Lancet Oncol. 2020 Mar;21[3]:335-7). This “seems to be higher” than the 0.29% prevalence of cancer in the overall Chinese population, the investigators noted at the time.

That study revealed 18 cancer patients among 1,590 COVID-19 cases, though it was “hypothesis generating,” according to Dr. Desai and colleagues, who rolled that data into their meta-analysis of 11 reports including 3,661 COVID-19 cases.

Overall, Dr. Desai and colleagues found the pooled prevalence of cancer was 2.0% (95% CI, 2.0%-3.0%) in that population. In a subgroup analysis of five studies with sample sizes of less than 100 COVID-19 patients, the researchers found a “slightly higher” prevalence of 3.0% (95% CI, 1.0%-6.0%).

However, even that data wasn’t robust enough for Dr. Desai and colleagues to make any pronouncements on cancer prevalence. “Overall, current evidence on the association between cancer and COVID-19 remains inconclusive,” they wrote.

Though inconclusive, the findings raise questions about whether treatments or interventions might need to be postponed in certain patients, whether cancer patients and survivors need stronger personal protection, and how to deal with potential delays in cancer clinical trials, according to Dr. Desai and colleagues.

“As the evidence continues to rise, we must strive to answer the unanswered clinical questions,” the authors wrote.

Dr. Desai and colleagues reported no potential conflicts of interest related to the study.

SOURCE: Desai A et al. JCO Glob Oncol. 2020 Apr 6. doi: 10.1200/GO.20.00097.

Patients with migraine who are unable to continue preventive procedures such as onabotulinumtoxinA injections during the COVID-19 pandemic may be at risk of worsening migraine, according to an article published March 30 in Headache. To address this scenario, clinicians may need to prescribe additional acute or preventive medications. Insurance providers should adjust their policies to facilitate transitions to other preventive therapies, including monoclonal antibodies against calcitonin gene-related peptide (CGRP) or the CGRP receptor, the authors said.

“This is a particularly vulnerable time for individuals with migraine and other disabling headache disorders, with many physical and mental stressors, increased anxiety, and changes in daily routine which may serve as triggering factors for worsening headache,” said lead author Christina L. Szperka, MD, director of the pediatric headache program at Children’s Hospital of Philadelphia, and colleagues.
 

Acute treatment

The authors described potential treatment regimens based on their experience as headache specialists and the experiences of their colleagues. For acute therapy options, NSAIDs, triptans, and neuroleptics may be used in combination when needed. Medications within the same drug category should not be combined, however, and triptans, dihydroergotamine, and lasmiditan should not be coadministered within 24 hours. Since the 2015 American Headache Society guideline for the acute treatment of migraine, the Food and Drug Administration has approved additional acute migraine medications, including ubrogepant, rimegepant, and lasmiditan, the authors said. The agency also cleared several neuromodulation devices for the acute treatment of migraine.

Although few drugs have been studied as treatments for unusually prolonged severe headaches, headache doctors often recommend NSAIDs before patients seek care at an emergency department or infusion center, the authors said. NSAID options include indomethacin, ketorolac, naproxen, nabumetone, diclofenac, and mefenamic acid. Neuroleptics also may be used. “Long-acting triptan medications can be used as bridge therapies, as is often done in the treatment of menstrually related migraine or in the treatment of medication overuse headache,” they said. “We propose a similar strategy can be trialed as a therapeutic option for refractory or persistent migraine.”

The authors also described the use of antiepileptics and corticosteroids, as well as drugs that may treat specific symptoms, such as difficulty sleeping (hydroxyzine or amitriptyline), neck or muscle pain (tizanidine), and aura with migraine (magnesium). Clinicians should avoid the use of opioids and butalbital, they said.
 

Preventive treatment

“While the injection of onabotulinumtoxinA is an effective treatment for chronic migraine, the procedure can put the patient and the provider at higher risk of COVID-19 given the close contact encounter,” wrote Dr. Szperka and colleagues. “We believe that other migraine preventive treatments should be utilized first when possible.” Since the publication of a guideline on preventive migraine therapies in 2012, the FDA has approved additional preventive therapies, including the anti-CGRP monoclonal antibodies erenumab‐aooe, galcanezumab‐gnlm, fremanezumab‐vfrm, and eptinezumab‐jjmr. “The first three are intended for self‐injection at home, with detailed instructions available for each product on its website,” they said.

Among angiotensin‐converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), candesartan has evidence of efficacy and tolerability in migraine prevention. Lisinopril has been considered possibly effective. “There has been recent concern in the media about the possibility of these medications interfering with the body’s response to COVID‐19,” the authors said, although this theoretical concern was not based on experimental or clinical data. “For patients in need of a new preventive therapy, the potential for benefit with an ACE/ARB must be weighed against the theoretical increased risk of infection.”

In addition, studies indicate that melatonin may prevent migraine with few side effects and that zonisamide may be effective in patients who have an inadequate response to or experience side effects with topiramate.
 

Policy changes and telehealth options

Effectively treating patients with migraine during the pandemic requires policy changes, according to the authors. “Migraine preventive prior authorization restrictions need to be lifted for evidence‐based, FDA‐approved therapies; patients need to be able to access these medications quickly and easily. Patients should not be required to fail older medications,” they said. “Similarly, in order to permit the transition of patients from onabotulinumtoxinA to anti‐CGRP [monoclonal antibodies], insurers should remove the prohibition against simultaneous coverage of these drug classes.” Insurers also should loosen restrictions on the off-label use of acute and preventive medication for adolescents, Dr. Szperka and coauthors suggest.

“In the era of COVID‐19, telehealth has become an essential modality for most headache specialists, given the need for providers to take significant precautions for both their patients and themselves, limiting touch or close contact,” they said. Patients with headache may warrant additional screening for COVID-19 as well. “As headache has been reported as an early symptom of COVID‐19, patients with worsening or new onset severe headache should be reviewed for exposure risk and any other symptoms which may be consistent with COVID‐19 infection,” the authors said.

There was no direct funding for the report. Dr. Szperka and a coauthor receive salary support from the National Institutes of Health. Dr. Szperka also has received grant support from Pfizer, and her institution has received compensation for her consulting work for Allergan. Several coauthors disclosed consulting and serving on speakers’ bureaus for and receiving research support from various pharmaceutical companies.

jremaly@mdedge.com

SOURCE: Szperka CL et al. Headache. 2020 Mar 30. doi: 10.1111/head.13810.

Patients with migraine who are unable to continue preventive procedures such as onabotulinumtoxinA injections during the COVID-19 pandemic may be at risk of worsening migraine, according to an article published March 30 in Headache. To address this scenario, clinicians may need to prescribe additional acute or preventive medications. Insurance providers should adjust their policies to facilitate transitions to other preventive therapies, including monoclonal antibodies against calcitonin gene-related peptide (CGRP) or the CGRP receptor, the authors said.

“This is a particularly vulnerable time for individuals with migraine and other disabling headache disorders, with many physical and mental stressors, increased anxiety, and changes in daily routine which may serve as triggering factors for worsening headache,” said lead author Christina L. Szperka, MD, director of the pediatric headache program at Children’s Hospital of Philadelphia, and colleagues.
 

Acute treatment

The authors described potential treatment regimens based on their experience as headache specialists and the experiences of their colleagues. For acute therapy options, NSAIDs, triptans, and neuroleptics may be used in combination when needed. Medications within the same drug category should not be combined, however, and triptans, dihydroergotamine, and lasmiditan should not be coadministered within 24 hours. Since the 2015 American Headache Society guideline for the acute treatment of migraine, the Food and Drug Administration has approved additional acute migraine medications, including ubrogepant, rimegepant, and lasmiditan, the authors said. The agency also cleared several neuromodulation devices for the acute treatment of migraine.

Although few drugs have been studied as treatments for unusually prolonged severe headaches, headache doctors often recommend NSAIDs before patients seek care at an emergency department or infusion center, the authors said. NSAID options include indomethacin, ketorolac, naproxen, nabumetone, diclofenac, and mefenamic acid. Neuroleptics also may be used. “Long-acting triptan medications can be used as bridge therapies, as is often done in the treatment of menstrually related migraine or in the treatment of medication overuse headache,” they said. “We propose a similar strategy can be trialed as a therapeutic option for refractory or persistent migraine.”

The authors also described the use of antiepileptics and corticosteroids, as well as drugs that may treat specific symptoms, such as difficulty sleeping (hydroxyzine or amitriptyline), neck or muscle pain (tizanidine), and aura with migraine (magnesium). Clinicians should avoid the use of opioids and butalbital, they said.
 

Preventive treatment

“While the injection of onabotulinumtoxinA is an effective treatment for chronic migraine, the procedure can put the patient and the provider at higher risk of COVID-19 given the close contact encounter,” wrote Dr. Szperka and colleagues. “We believe that other migraine preventive treatments should be utilized first when possible.” Since the publication of a guideline on preventive migraine therapies in 2012, the FDA has approved additional preventive therapies, including the anti-CGRP monoclonal antibodies erenumab‐aooe, galcanezumab‐gnlm, fremanezumab‐vfrm, and eptinezumab‐jjmr. “The first three are intended for self‐injection at home, with detailed instructions available for each product on its website,” they said.

Among angiotensin‐converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), candesartan has evidence of efficacy and tolerability in migraine prevention. Lisinopril has been considered possibly effective. “There has been recent concern in the media about the possibility of these medications interfering with the body’s response to COVID‐19,” the authors said, although this theoretical concern was not based on experimental or clinical data. “For patients in need of a new preventive therapy, the potential for benefit with an ACE/ARB must be weighed against the theoretical increased risk of infection.”

In addition, studies indicate that melatonin may prevent migraine with few side effects and that zonisamide may be effective in patients who have an inadequate response to or experience side effects with topiramate.
 

Policy changes and telehealth options

Effectively treating patients with migraine during the pandemic requires policy changes, according to the authors. “Migraine preventive prior authorization restrictions need to be lifted for evidence‐based, FDA‐approved therapies; patients need to be able to access these medications quickly and easily. Patients should not be required to fail older medications,” they said. “Similarly, in order to permit the transition of patients from onabotulinumtoxinA to anti‐CGRP [monoclonal antibodies], insurers should remove the prohibition against simultaneous coverage of these drug classes.” Insurers also should loosen restrictions on the off-label use of acute and preventive medication for adolescents, Dr. Szperka and coauthors suggest.

“In the era of COVID‐19, telehealth has become an essential modality for most headache specialists, given the need for providers to take significant precautions for both their patients and themselves, limiting touch or close contact,” they said. Patients with headache may warrant additional screening for COVID-19 as well. “As headache has been reported as an early symptom of COVID‐19, patients with worsening or new onset severe headache should be reviewed for exposure risk and any other symptoms which may be consistent with COVID‐19 infection,” the authors said.

There was no direct funding for the report. Dr. Szperka and a coauthor receive salary support from the National Institutes of Health. Dr. Szperka also has received grant support from Pfizer, and her institution has received compensation for her consulting work for Allergan. Several coauthors disclosed consulting and serving on speakers’ bureaus for and receiving research support from various pharmaceutical companies.

jremaly@mdedge.com

SOURCE: Szperka CL et al. Headache. 2020 Mar 30. doi: 10.1111/head.13810.

Patients with migraine who are unable to continue preventive procedures such as onabotulinumtoxinA injections during the COVID-19 pandemic may be at risk of worsening migraine, according to an article published March 30 in Headache. To address this scenario, clinicians may need to prescribe additional acute or preventive medications. Insurance providers should adjust their policies to facilitate transitions to other preventive therapies, including monoclonal antibodies against calcitonin gene-related peptide (CGRP) or the CGRP receptor, the authors said.

“This is a particularly vulnerable time for individuals with migraine and other disabling headache disorders, with many physical and mental stressors, increased anxiety, and changes in daily routine which may serve as triggering factors for worsening headache,” said lead author Christina L. Szperka, MD, director of the pediatric headache program at Children’s Hospital of Philadelphia, and colleagues.
 

Acute treatment

The authors described potential treatment regimens based on their experience as headache specialists and the experiences of their colleagues. For acute therapy options, NSAIDs, triptans, and neuroleptics may be used in combination when needed. Medications within the same drug category should not be combined, however, and triptans, dihydroergotamine, and lasmiditan should not be coadministered within 24 hours. Since the 2015 American Headache Society guideline for the acute treatment of migraine, the Food and Drug Administration has approved additional acute migraine medications, including ubrogepant, rimegepant, and lasmiditan, the authors said. The agency also cleared several neuromodulation devices for the acute treatment of migraine.

Although few drugs have been studied as treatments for unusually prolonged severe headaches, headache doctors often recommend NSAIDs before patients seek care at an emergency department or infusion center, the authors said. NSAID options include indomethacin, ketorolac, naproxen, nabumetone, diclofenac, and mefenamic acid. Neuroleptics also may be used. “Long-acting triptan medications can be used as bridge therapies, as is often done in the treatment of menstrually related migraine or in the treatment of medication overuse headache,” they said. “We propose a similar strategy can be trialed as a therapeutic option for refractory or persistent migraine.”

The authors also described the use of antiepileptics and corticosteroids, as well as drugs that may treat specific symptoms, such as difficulty sleeping (hydroxyzine or amitriptyline), neck or muscle pain (tizanidine), and aura with migraine (magnesium). Clinicians should avoid the use of opioids and butalbital, they said.
 

Preventive treatment

“While the injection of onabotulinumtoxinA is an effective treatment for chronic migraine, the procedure can put the patient and the provider at higher risk of COVID-19 given the close contact encounter,” wrote Dr. Szperka and colleagues. “We believe that other migraine preventive treatments should be utilized first when possible.” Since the publication of a guideline on preventive migraine therapies in 2012, the FDA has approved additional preventive therapies, including the anti-CGRP monoclonal antibodies erenumab‐aooe, galcanezumab‐gnlm, fremanezumab‐vfrm, and eptinezumab‐jjmr. “The first three are intended for self‐injection at home, with detailed instructions available for each product on its website,” they said.

Among angiotensin‐converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), candesartan has evidence of efficacy and tolerability in migraine prevention. Lisinopril has been considered possibly effective. “There has been recent concern in the media about the possibility of these medications interfering with the body’s response to COVID‐19,” the authors said, although this theoretical concern was not based on experimental or clinical data. “For patients in need of a new preventive therapy, the potential for benefit with an ACE/ARB must be weighed against the theoretical increased risk of infection.”

In addition, studies indicate that melatonin may prevent migraine with few side effects and that zonisamide may be effective in patients who have an inadequate response to or experience side effects with topiramate.
 

Policy changes and telehealth options

Effectively treating patients with migraine during the pandemic requires policy changes, according to the authors. “Migraine preventive prior authorization restrictions need to be lifted for evidence‐based, FDA‐approved therapies; patients need to be able to access these medications quickly and easily. Patients should not be required to fail older medications,” they said. “Similarly, in order to permit the transition of patients from onabotulinumtoxinA to anti‐CGRP [monoclonal antibodies], insurers should remove the prohibition against simultaneous coverage of these drug classes.” Insurers also should loosen restrictions on the off-label use of acute and preventive medication for adolescents, Dr. Szperka and coauthors suggest.

“In the era of COVID‐19, telehealth has become an essential modality for most headache specialists, given the need for providers to take significant precautions for both their patients and themselves, limiting touch or close contact,” they said. Patients with headache may warrant additional screening for COVID-19 as well. “As headache has been reported as an early symptom of COVID‐19, patients with worsening or new onset severe headache should be reviewed for exposure risk and any other symptoms which may be consistent with COVID‐19 infection,” the authors said.

There was no direct funding for the report. Dr. Szperka and a coauthor receive salary support from the National Institutes of Health. Dr. Szperka also has received grant support from Pfizer, and her institution has received compensation for her consulting work for Allergan. Several coauthors disclosed consulting and serving on speakers’ bureaus for and receiving research support from various pharmaceutical companies.

jremaly@mdedge.com

SOURCE: Szperka CL et al. Headache. 2020 Mar 30. doi: 10.1111/head.13810.

Count Vikram Sengupta, MD, among the slew of health care workers feeling overwhelmed by the impact that COVID-19 is having on the delivery of health care in Manhattan and its surrounding boroughs.

“Nobody in the country is suffering like New York City,” said Dr. Sengupta, chief medical officer of Thrivewell Infusion, which operates three stand-alone infusion centers in the region: a four-chair center in Crown Heights, a 10-chair center in Borough Park, Brooklyn, and an eight-chair center in Manhasset. “We have 30%-50% of all cases in the country. I’ve been reading the news, and some people think this thing is going away. We’re in great distress here. There need to be new strategies moving forward. The whole world has changed. Our whole approach to ambulatory care has changed.”

In early March 2020, when it became clear that New York hospitals would face a tidal wave of citizens infected with COVID-19, Thrivewell began to receive an influx of referrals originating from concerned patients, providers, payers, and even large integrated health care systems, all in an effort to help prevent infectious exposure through infusion in hospital-based settings. “We are trying to accommodate them as swiftly as possible,” said Dr. Sengupta, who was interviewed for this story on April 9. “There’s been a huge uptick from that standpoint. We’ve made sure that we’ve kept our facilities clean by employing standards that have been released by the CDC, as well as by the major academic centers who are dealing with this firsthand, and also with guidance from the National Infusion Center Association.”

He and his colleagues launched a pop-up infusion center in the Bronx to help offload Montefiore Medical Center, “because they’re so overwhelmed with COVID-19 patients that they need help taking care of the autoimmune patients,” Dr. Sengupta said. “That’s the role we’re playing. We’ve made our resources available to these centers in a very flexible way in order to ensure that we do the best thing we can for everybody.”

Thrivewell is also deploying a mobile infusion unit to recovered COVID-19 patients who require an infusion for their autoimmune disease, in order to minimize the risk of contamination and transmission in their stand-alone centers. The RV-sized unit, about the size of a Bloodmobile, is equipped with infusion chairs and staffed by a physician and nurse practitioner. “The objective is continuant care and reduction of cross-contamination, and also, on a broader health care systems level, to ensure that we as ambulatory infusion center providers can offload an overburdened system,” he said.

Dr. Sengupta, who has assisted on COVID-19 inpatient wards at New York University as a volunteer, is also leading a trial of a stem cell-derived therapy developed by Israel-based Pluristem Therapeutics, to treat New York–area patients severely ill from COVID-19 infection. “There are reports from Wuhan, China, in which clinicians are delivering IV mesenchymal stem cells to patients who are on mechanical ventilators, and the patients are getting better,” he said. “I have initiated a study in which we have three cohorts: One is the outpatient setting in which we are trying to treat COVID-19 patients who have hypoxia but have been turned away from overwhelmed EDs and need some therapy. We will be converting one of our infusion centers to conduct this trial. We are also going to be administering this [stem cell-derived therapy] to COVID-19 patients in ICUs, in EDs, and on med-surg floors throughout the city.”

dbrunk@mdedge.com

Count Vikram Sengupta, MD, among the slew of health care workers feeling overwhelmed by the impact that COVID-19 is having on the delivery of health care in Manhattan and its surrounding boroughs.

“Nobody in the country is suffering like New York City,” said Dr. Sengupta, chief medical officer of Thrivewell Infusion, which operates three stand-alone infusion centers in the region: a four-chair center in Crown Heights, a 10-chair center in Borough Park, Brooklyn, and an eight-chair center in Manhasset. “We have 30%-50% of all cases in the country. I’ve been reading the news, and some people think this thing is going away. We’re in great distress here. There need to be new strategies moving forward. The whole world has changed. Our whole approach to ambulatory care has changed.”

In early March 2020, when it became clear that New York hospitals would face a tidal wave of citizens infected with COVID-19, Thrivewell began to receive an influx of referrals originating from concerned patients, providers, payers, and even large integrated health care systems, all in an effort to help prevent infectious exposure through infusion in hospital-based settings. “We are trying to accommodate them as swiftly as possible,” said Dr. Sengupta, who was interviewed for this story on April 9. “There’s been a huge uptick from that standpoint. We’ve made sure that we’ve kept our facilities clean by employing standards that have been released by the CDC, as well as by the major academic centers who are dealing with this firsthand, and also with guidance from the National Infusion Center Association.”

He and his colleagues launched a pop-up infusion center in the Bronx to help offload Montefiore Medical Center, “because they’re so overwhelmed with COVID-19 patients that they need help taking care of the autoimmune patients,” Dr. Sengupta said. “That’s the role we’re playing. We’ve made our resources available to these centers in a very flexible way in order to ensure that we do the best thing we can for everybody.”

Thrivewell is also deploying a mobile infusion unit to recovered COVID-19 patients who require an infusion for their autoimmune disease, in order to minimize the risk of contamination and transmission in their stand-alone centers. The RV-sized unit, about the size of a Bloodmobile, is equipped with infusion chairs and staffed by a physician and nurse practitioner. “The objective is continuant care and reduction of cross-contamination, and also, on a broader health care systems level, to ensure that we as ambulatory infusion center providers can offload an overburdened system,” he said.

Dr. Sengupta, who has assisted on COVID-19 inpatient wards at New York University as a volunteer, is also leading a trial of a stem cell-derived therapy developed by Israel-based Pluristem Therapeutics, to treat New York–area patients severely ill from COVID-19 infection. “There are reports from Wuhan, China, in which clinicians are delivering IV mesenchymal stem cells to patients who are on mechanical ventilators, and the patients are getting better,” he said. “I have initiated a study in which we have three cohorts: One is the outpatient setting in which we are trying to treat COVID-19 patients who have hypoxia but have been turned away from overwhelmed EDs and need some therapy. We will be converting one of our infusion centers to conduct this trial. We are also going to be administering this [stem cell-derived therapy] to COVID-19 patients in ICUs, in EDs, and on med-surg floors throughout the city.”

dbrunk@mdedge.com

Count Vikram Sengupta, MD, among the slew of health care workers feeling overwhelmed by the impact that COVID-19 is having on the delivery of health care in Manhattan and its surrounding boroughs.

“Nobody in the country is suffering like New York City,” said Dr. Sengupta, chief medical officer of Thrivewell Infusion, which operates three stand-alone infusion centers in the region: a four-chair center in Crown Heights, a 10-chair center in Borough Park, Brooklyn, and an eight-chair center in Manhasset. “We have 30%-50% of all cases in the country. I’ve been reading the news, and some people think this thing is going away. We’re in great distress here. There need to be new strategies moving forward. The whole world has changed. Our whole approach to ambulatory care has changed.”

In early March 2020, when it became clear that New York hospitals would face a tidal wave of citizens infected with COVID-19, Thrivewell began to receive an influx of referrals originating from concerned patients, providers, payers, and even large integrated health care systems, all in an effort to help prevent infectious exposure through infusion in hospital-based settings. “We are trying to accommodate them as swiftly as possible,” said Dr. Sengupta, who was interviewed for this story on April 9. “There’s been a huge uptick from that standpoint. We’ve made sure that we’ve kept our facilities clean by employing standards that have been released by the CDC, as well as by the major academic centers who are dealing with this firsthand, and also with guidance from the National Infusion Center Association.”

He and his colleagues launched a pop-up infusion center in the Bronx to help offload Montefiore Medical Center, “because they’re so overwhelmed with COVID-19 patients that they need help taking care of the autoimmune patients,” Dr. Sengupta said. “That’s the role we’re playing. We’ve made our resources available to these centers in a very flexible way in order to ensure that we do the best thing we can for everybody.”

Thrivewell is also deploying a mobile infusion unit to recovered COVID-19 patients who require an infusion for their autoimmune disease, in order to minimize the risk of contamination and transmission in their stand-alone centers. The RV-sized unit, about the size of a Bloodmobile, is equipped with infusion chairs and staffed by a physician and nurse practitioner. “The objective is continuant care and reduction of cross-contamination, and also, on a broader health care systems level, to ensure that we as ambulatory infusion center providers can offload an overburdened system,” he said.

Dr. Sengupta, who has assisted on COVID-19 inpatient wards at New York University as a volunteer, is also leading a trial of a stem cell-derived therapy developed by Israel-based Pluristem Therapeutics, to treat New York–area patients severely ill from COVID-19 infection. “There are reports from Wuhan, China, in which clinicians are delivering IV mesenchymal stem cells to patients who are on mechanical ventilators, and the patients are getting better,” he said. “I have initiated a study in which we have three cohorts: One is the outpatient setting in which we are trying to treat COVID-19 patients who have hypoxia but have been turned away from overwhelmed EDs and need some therapy. We will be converting one of our infusion centers to conduct this trial. We are also going to be administering this [stem cell-derived therapy] to COVID-19 patients in ICUs, in EDs, and on med-surg floors throughout the city.”

dbrunk@mdedge.com