COVID-19 Updates

If you are anything like me, March 1 came and went as just another first day of the month. Few of us could have imagined that our day-to-day way of life would soon be upended, and our country would be in the midst of the COVID-19 pandemic. While there is considerable anxiety around protecting our individual health, social distancing and the physical isolation that comes from it have cut off a vital source of support for many of our lesbian, gay, bisexual, transgender, and questioning (or queer) (LGBTQ) youth. Shared experiences with other young people like themselves provide these youth with a sense of community that they may not find in their schools, towns, etc.

LGBTQ youth already face increased rates of anxiety and depression compared with their heterosexual and cisgender peers. According to the 2017 Youth Risk Behavior Survey, 63% of LGB youth nationwide reported feeling sad or hopeless compared with 28% of their heterosexual peers. While quarantined at home, many of these youth now are stuck for many more hours per day with families who may not accept them for who they are. Previous research by Ryan et al. shows that LGB adolescents who have higher rates of family rejection are nearly six times more likely to have higher rates of depression and more than eight times more likely to attempt suicide than their peers who come from families with low or no levels of rejection (Pediatrics. 2009 Jan;123[1]:346-52). Going to school for roughly 8 hours a day allows some of these youth an escape from what is otherwise an unpleasant home situation. In addition, educators and other school staff may be among the only allies that a student has in his/her life, and school cancellations remove students from access to these important people.

AJ_Watt/E+

Due to stay-at-home orders and physical distancing measures, lack of in-person access to medical and psychological care can be distressing for many LGBTQ youth. While many practices have been able to convert to audiovisual telemedicine visits, not all of them have the resources or capability to do so. Consequently, LGBTQ youth may have reduced access to support services that help to bolster their social and emotional health. In addition, many trans youth suffer from physical dysphoria that can make it distressing to see themselves on camera doing teletherapy and so they wish to avoid it for this reason.

This is not to say that everything is bleak. LGBTQ youth can also be resilient in times of stress and worry. “The LGBTQ community has a long history of overcoming adversity and utilizing challenges to build an even stronger sense of community. This pandemic will create yet another opportunity for us to highlight existing health disparities and to support our LGBTQ young people in finding creative responses,” said Heather Newby, LCSW, clinical social worker for the GENECIS (GENder Education and Care Interdisciplinary Support) Program at Children’s Medical Center Dallas. In addition, she reported that many LGBTQ advocacy groups have created excellent online support networks and resources to provide nationwide, regional, and local help. By leveraging these youths’ capability for resilience, we are best able to support them during a time of crisis.

During these challenging times, there are a number of resources that LGBTQ youth can turn to while trying to maintain their connection to their peers. First, many local LGBTQ service organizations have moved their in-person support groups to a virtual or online platform. Check with your local service organization to see what they are offering during these times. National organizations, such as Gender Spectrum, continue to have online groups as well that youth can participate in. Second, many virtual mental health helplines, such as those through the Trevor Project, remain staffed should LGBTQ youth need to access their services (1-866-488-7386, plus text and chat). They can be reached 24/7 to help those whose mental health has been affected during this pandemic. Third, youth can continue to stay connected to their friends through means such as Zoom, FaceTime, or other virtual audiovisual tools. Lastly, some youth have taken to meeting in school parking lots, mall parking lots, etc., and staying at least 6 feet apart so that they can still see their friends in person.

While the current times may be challenging, they will pass and we will be able to return to those activities that bring us joy. Do not hesitate to reach out if you need help. As Rainer Maria Rilke once said, “In the difficult, we must have our joys, our happiness, our dreams: There against the depth of this background, they stand out, there for the first time we see how beautiful they are.”
 

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. He has no relevant financial disclosures. Dr. Cooper is on Twitter @teendocmbc. Email him at pdnews@mdedge.com.

If you are anything like me, March 1 came and went as just another first day of the month. Few of us could have imagined that our day-to-day way of life would soon be upended, and our country would be in the midst of the COVID-19 pandemic. While there is considerable anxiety around protecting our individual health, social distancing and the physical isolation that comes from it have cut off a vital source of support for many of our lesbian, gay, bisexual, transgender, and questioning (or queer) (LGBTQ) youth. Shared experiences with other young people like themselves provide these youth with a sense of community that they may not find in their schools, towns, etc.

LGBTQ youth already face increased rates of anxiety and depression compared with their heterosexual and cisgender peers. According to the 2017 Youth Risk Behavior Survey, 63% of LGB youth nationwide reported feeling sad or hopeless compared with 28% of their heterosexual peers. While quarantined at home, many of these youth now are stuck for many more hours per day with families who may not accept them for who they are. Previous research by Ryan et al. shows that LGB adolescents who have higher rates of family rejection are nearly six times more likely to have higher rates of depression and more than eight times more likely to attempt suicide than their peers who come from families with low or no levels of rejection (Pediatrics. 2009 Jan;123[1]:346-52). Going to school for roughly 8 hours a day allows some of these youth an escape from what is otherwise an unpleasant home situation. In addition, educators and other school staff may be among the only allies that a student has in his/her life, and school cancellations remove students from access to these important people.

AJ_Watt/E+

Due to stay-at-home orders and physical distancing measures, lack of in-person access to medical and psychological care can be distressing for many LGBTQ youth. While many practices have been able to convert to audiovisual telemedicine visits, not all of them have the resources or capability to do so. Consequently, LGBTQ youth may have reduced access to support services that help to bolster their social and emotional health. In addition, many trans youth suffer from physical dysphoria that can make it distressing to see themselves on camera doing teletherapy and so they wish to avoid it for this reason.

This is not to say that everything is bleak. LGBTQ youth can also be resilient in times of stress and worry. “The LGBTQ community has a long history of overcoming adversity and utilizing challenges to build an even stronger sense of community. This pandemic will create yet another opportunity for us to highlight existing health disparities and to support our LGBTQ young people in finding creative responses,” said Heather Newby, LCSW, clinical social worker for the GENECIS (GENder Education and Care Interdisciplinary Support) Program at Children’s Medical Center Dallas. In addition, she reported that many LGBTQ advocacy groups have created excellent online support networks and resources to provide nationwide, regional, and local help. By leveraging these youths’ capability for resilience, we are best able to support them during a time of crisis.

During these challenging times, there are a number of resources that LGBTQ youth can turn to while trying to maintain their connection to their peers. First, many local LGBTQ service organizations have moved their in-person support groups to a virtual or online platform. Check with your local service organization to see what they are offering during these times. National organizations, such as Gender Spectrum, continue to have online groups as well that youth can participate in. Second, many virtual mental health helplines, such as those through the Trevor Project, remain staffed should LGBTQ youth need to access their services (1-866-488-7386, plus text and chat). They can be reached 24/7 to help those whose mental health has been affected during this pandemic. Third, youth can continue to stay connected to their friends through means such as Zoom, FaceTime, or other virtual audiovisual tools. Lastly, some youth have taken to meeting in school parking lots, mall parking lots, etc., and staying at least 6 feet apart so that they can still see their friends in person.

While the current times may be challenging, they will pass and we will be able to return to those activities that bring us joy. Do not hesitate to reach out if you need help. As Rainer Maria Rilke once said, “In the difficult, we must have our joys, our happiness, our dreams: There against the depth of this background, they stand out, there for the first time we see how beautiful they are.”
 

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. He has no relevant financial disclosures. Dr. Cooper is on Twitter @teendocmbc. Email him at pdnews@mdedge.com.

If you are anything like me, March 1 came and went as just another first day of the month. Few of us could have imagined that our day-to-day way of life would soon be upended, and our country would be in the midst of the COVID-19 pandemic. While there is considerable anxiety around protecting our individual health, social distancing and the physical isolation that comes from it have cut off a vital source of support for many of our lesbian, gay, bisexual, transgender, and questioning (or queer) (LGBTQ) youth. Shared experiences with other young people like themselves provide these youth with a sense of community that they may not find in their schools, towns, etc.

LGBTQ youth already face increased rates of anxiety and depression compared with their heterosexual and cisgender peers. According to the 2017 Youth Risk Behavior Survey, 63% of LGB youth nationwide reported feeling sad or hopeless compared with 28% of their heterosexual peers. While quarantined at home, many of these youth now are stuck for many more hours per day with families who may not accept them for who they are. Previous research by Ryan et al. shows that LGB adolescents who have higher rates of family rejection are nearly six times more likely to have higher rates of depression and more than eight times more likely to attempt suicide than their peers who come from families with low or no levels of rejection (Pediatrics. 2009 Jan;123[1]:346-52). Going to school for roughly 8 hours a day allows some of these youth an escape from what is otherwise an unpleasant home situation. In addition, educators and other school staff may be among the only allies that a student has in his/her life, and school cancellations remove students from access to these important people.

AJ_Watt/E+

Due to stay-at-home orders and physical distancing measures, lack of in-person access to medical and psychological care can be distressing for many LGBTQ youth. While many practices have been able to convert to audiovisual telemedicine visits, not all of them have the resources or capability to do so. Consequently, LGBTQ youth may have reduced access to support services that help to bolster their social and emotional health. In addition, many trans youth suffer from physical dysphoria that can make it distressing to see themselves on camera doing teletherapy and so they wish to avoid it for this reason.

This is not to say that everything is bleak. LGBTQ youth can also be resilient in times of stress and worry. “The LGBTQ community has a long history of overcoming adversity and utilizing challenges to build an even stronger sense of community. This pandemic will create yet another opportunity for us to highlight existing health disparities and to support our LGBTQ young people in finding creative responses,” said Heather Newby, LCSW, clinical social worker for the GENECIS (GENder Education and Care Interdisciplinary Support) Program at Children’s Medical Center Dallas. In addition, she reported that many LGBTQ advocacy groups have created excellent online support networks and resources to provide nationwide, regional, and local help. By leveraging these youths’ capability for resilience, we are best able to support them during a time of crisis.

During these challenging times, there are a number of resources that LGBTQ youth can turn to while trying to maintain their connection to their peers. First, many local LGBTQ service organizations have moved their in-person support groups to a virtual or online platform. Check with your local service organization to see what they are offering during these times. National organizations, such as Gender Spectrum, continue to have online groups as well that youth can participate in. Second, many virtual mental health helplines, such as those through the Trevor Project, remain staffed should LGBTQ youth need to access their services (1-866-488-7386, plus text and chat). They can be reached 24/7 to help those whose mental health has been affected during this pandemic. Third, youth can continue to stay connected to their friends through means such as Zoom, FaceTime, or other virtual audiovisual tools. Lastly, some youth have taken to meeting in school parking lots, mall parking lots, etc., and staying at least 6 feet apart so that they can still see their friends in person.

While the current times may be challenging, they will pass and we will be able to return to those activities that bring us joy. Do not hesitate to reach out if you need help. As Rainer Maria Rilke once said, “In the difficult, we must have our joys, our happiness, our dreams: There against the depth of this background, they stand out, there for the first time we see how beautiful they are.”
 

Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas. He has no relevant financial disclosures. Dr. Cooper is on Twitter @teendocmbc. Email him at pdnews@mdedge.com.

As the COVID-19 pandemic forces rationing of ventilators, intensive care beds, and other resources, oncologists need to advocate for their patients and to support informed decision making as to resource allocation, both at the institutional and regional level, according to new recommendations from the American Society for Clinical Oncology (ASCO).

“There was a lot of concern from the oncology community that if a patient had cancer, they would be arbitrarily excluded from consideration for critical care resources,” said Jonathan M. Marron, MD, chair-elect of ASCO’s Ethics Committee and lead author of the recommendations.

“The hope is that we’ll never have to make any of these decisions ... but the primary reason for putting together these recommendations was that if such decisions have to be made, we hope to inform them,” he told Medscape Medical News.

Marron, who is a pediatric hematologist at Boston Children’s Hospital, says ASCO’s main recommendation is that decisions about the allocation of resources must be separated from bedside clinical care, meaning that clinicians who are caring for individual patients should not also be the ones making the allocation decisions.

“Those dueling responsibilities are a conflict of interest and make that physician unable to make an unbiased decision,” he said.

“It’s also just an unbearable burden to try and do those two things simultaneously,” he added. “It’s an incredible burden to do them individually, but it’s multifold worse to try to do them both simultaneously.”

He said the vital role of oncologists who provide treatment is to offer the kind of personalized information that triage committees need in order to make appropriate decisions.

“They should be asked – maybe even must be asked – to provide the most high-quality evidence-based data about their patients’ diagnosis and prognosis,” Marron commented. “Because oncology is evolving so rapidly, and cancer is so many different diseases, it’s impossible for someone making these decisions to know everything they would need to know about why this patient is likely to survive their cancer and this patient is not.”

He says that during the COVID-19 pandemic, concerns regarding public health transcend the well-being of individual patients and that consideration must be given to providing the maximum benefit to the greatest number of people.

“That makes perfect sense and is the appropriate and laudable goal during a public health emergency like this ... but one of the challenges is that there is this belief that a diagnosis of cancer is uniformly fatal,” Marron said.

“It’s certainly conceivable that it would be a better use of resources to give the last ventilator to a young, otherwise healthy patient rather than a patient with multiply recurrent progressive metastatic cancer,” he continued. “However, we want to ensure that there is at least a discussion where that information is made available, rather than just saying, ‘She’s got cancer. She’s a lost cause.’ ”
 

Cancer patients are doing very well

Concerns about cancer misconceptions have been circulating in the oncology community since the start of the pandemic. “It’s really important that people understand that cancer patients are doing very well nowadays, and even with a diagnosis of cancer, they can potentially live for many years,” Anne Chiang, MD, PhD, from the Smilow Cancer Network, New Haven, Connecticut, told Medscape Medical News in a recent interview.

Thus far, even in hard-hit New York City, fears that cancer patients may not be receiving appropriate care have not materialized, according to Mark Robson, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center (MSKCC). “I would emphasize that cancer patients are ABSOLUTELY getting the care they need, including patients with metastatic disease,” he recently tweeted. “NOONE at @sloan_kettering (or anywhere else) is being ‘triaged’ because of advanced cancer. Period.”

Robson told Medscape Medical News that although MSKCC continues to provide oncology care to patients with cancer, “we are [also] treating them if they develop COVID. ... I am trying to help pivot the institution towards care in this setting.”

He said he agrees with Craig Spencer, MD, MPH, director of global health in emergency medicine at the New York–Presbyterian/Columbia University Medical Center, who recently tweeted, “If you need a ventilator, you get a ventilator. Let’s be clear – this isn’t being ‘rationed.’ ”

Marron emphasized that an important safeguard against uninformed decision making is appropriate planning. For hospitalized patients, this means oncologists who provide treatment should offer information even before it is requested. But he said the “duty to plan” begins long before that.

“Clinicians haven’t always been great at talking about death and long-term outcomes with their patients, but this really cranks up the importance of having those conversations, and having them early, even though it’s incredibly hard. If someone has expressed that they would never want to be put on a ventilator, it’s important now even more so that is made clear,” he said.

He said early responses to the ASCO statement suggest that it has calmed some concerns in the oncology community, “but it still remains to be seen whether individual institutions will take this to heart, because this unto itself cannot enforce anything – it is up to individual institutions. I am hopeful this will get to the people it needs to get to.”

This article first appeared on Medscape.com.

As the COVID-19 pandemic forces rationing of ventilators, intensive care beds, and other resources, oncologists need to advocate for their patients and to support informed decision making as to resource allocation, both at the institutional and regional level, according to new recommendations from the American Society for Clinical Oncology (ASCO).

“There was a lot of concern from the oncology community that if a patient had cancer, they would be arbitrarily excluded from consideration for critical care resources,” said Jonathan M. Marron, MD, chair-elect of ASCO’s Ethics Committee and lead author of the recommendations.

“The hope is that we’ll never have to make any of these decisions ... but the primary reason for putting together these recommendations was that if such decisions have to be made, we hope to inform them,” he told Medscape Medical News.

Marron, who is a pediatric hematologist at Boston Children’s Hospital, says ASCO’s main recommendation is that decisions about the allocation of resources must be separated from bedside clinical care, meaning that clinicians who are caring for individual patients should not also be the ones making the allocation decisions.

“Those dueling responsibilities are a conflict of interest and make that physician unable to make an unbiased decision,” he said.

“It’s also just an unbearable burden to try and do those two things simultaneously,” he added. “It’s an incredible burden to do them individually, but it’s multifold worse to try to do them both simultaneously.”

He said the vital role of oncologists who provide treatment is to offer the kind of personalized information that triage committees need in order to make appropriate decisions.

“They should be asked – maybe even must be asked – to provide the most high-quality evidence-based data about their patients’ diagnosis and prognosis,” Marron commented. “Because oncology is evolving so rapidly, and cancer is so many different diseases, it’s impossible for someone making these decisions to know everything they would need to know about why this patient is likely to survive their cancer and this patient is not.”

He says that during the COVID-19 pandemic, concerns regarding public health transcend the well-being of individual patients and that consideration must be given to providing the maximum benefit to the greatest number of people.

“That makes perfect sense and is the appropriate and laudable goal during a public health emergency like this ... but one of the challenges is that there is this belief that a diagnosis of cancer is uniformly fatal,” Marron said.

“It’s certainly conceivable that it would be a better use of resources to give the last ventilator to a young, otherwise healthy patient rather than a patient with multiply recurrent progressive metastatic cancer,” he continued. “However, we want to ensure that there is at least a discussion where that information is made available, rather than just saying, ‘She’s got cancer. She’s a lost cause.’ ”
 

Cancer patients are doing very well

Concerns about cancer misconceptions have been circulating in the oncology community since the start of the pandemic. “It’s really important that people understand that cancer patients are doing very well nowadays, and even with a diagnosis of cancer, they can potentially live for many years,” Anne Chiang, MD, PhD, from the Smilow Cancer Network, New Haven, Connecticut, told Medscape Medical News in a recent interview.

Thus far, even in hard-hit New York City, fears that cancer patients may not be receiving appropriate care have not materialized, according to Mark Robson, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center (MSKCC). “I would emphasize that cancer patients are ABSOLUTELY getting the care they need, including patients with metastatic disease,” he recently tweeted. “NOONE at @sloan_kettering (or anywhere else) is being ‘triaged’ because of advanced cancer. Period.”

Robson told Medscape Medical News that although MSKCC continues to provide oncology care to patients with cancer, “we are [also] treating them if they develop COVID. ... I am trying to help pivot the institution towards care in this setting.”

He said he agrees with Craig Spencer, MD, MPH, director of global health in emergency medicine at the New York–Presbyterian/Columbia University Medical Center, who recently tweeted, “If you need a ventilator, you get a ventilator. Let’s be clear – this isn’t being ‘rationed.’ ”

Marron emphasized that an important safeguard against uninformed decision making is appropriate planning. For hospitalized patients, this means oncologists who provide treatment should offer information even before it is requested. But he said the “duty to plan” begins long before that.

“Clinicians haven’t always been great at talking about death and long-term outcomes with their patients, but this really cranks up the importance of having those conversations, and having them early, even though it’s incredibly hard. If someone has expressed that they would never want to be put on a ventilator, it’s important now even more so that is made clear,” he said.

He said early responses to the ASCO statement suggest that it has calmed some concerns in the oncology community, “but it still remains to be seen whether individual institutions will take this to heart, because this unto itself cannot enforce anything – it is up to individual institutions. I am hopeful this will get to the people it needs to get to.”

This article first appeared on Medscape.com.

As the COVID-19 pandemic forces rationing of ventilators, intensive care beds, and other resources, oncologists need to advocate for their patients and to support informed decision making as to resource allocation, both at the institutional and regional level, according to new recommendations from the American Society for Clinical Oncology (ASCO).

“There was a lot of concern from the oncology community that if a patient had cancer, they would be arbitrarily excluded from consideration for critical care resources,” said Jonathan M. Marron, MD, chair-elect of ASCO’s Ethics Committee and lead author of the recommendations.

“The hope is that we’ll never have to make any of these decisions ... but the primary reason for putting together these recommendations was that if such decisions have to be made, we hope to inform them,” he told Medscape Medical News.

Marron, who is a pediatric hematologist at Boston Children’s Hospital, says ASCO’s main recommendation is that decisions about the allocation of resources must be separated from bedside clinical care, meaning that clinicians who are caring for individual patients should not also be the ones making the allocation decisions.

“Those dueling responsibilities are a conflict of interest and make that physician unable to make an unbiased decision,” he said.

“It’s also just an unbearable burden to try and do those two things simultaneously,” he added. “It’s an incredible burden to do them individually, but it’s multifold worse to try to do them both simultaneously.”

He said the vital role of oncologists who provide treatment is to offer the kind of personalized information that triage committees need in order to make appropriate decisions.

“They should be asked – maybe even must be asked – to provide the most high-quality evidence-based data about their patients’ diagnosis and prognosis,” Marron commented. “Because oncology is evolving so rapidly, and cancer is so many different diseases, it’s impossible for someone making these decisions to know everything they would need to know about why this patient is likely to survive their cancer and this patient is not.”

He says that during the COVID-19 pandemic, concerns regarding public health transcend the well-being of individual patients and that consideration must be given to providing the maximum benefit to the greatest number of people.

“That makes perfect sense and is the appropriate and laudable goal during a public health emergency like this ... but one of the challenges is that there is this belief that a diagnosis of cancer is uniformly fatal,” Marron said.

“It’s certainly conceivable that it would be a better use of resources to give the last ventilator to a young, otherwise healthy patient rather than a patient with multiply recurrent progressive metastatic cancer,” he continued. “However, we want to ensure that there is at least a discussion where that information is made available, rather than just saying, ‘She’s got cancer. She’s a lost cause.’ ”
 

Cancer patients are doing very well

Concerns about cancer misconceptions have been circulating in the oncology community since the start of the pandemic. “It’s really important that people understand that cancer patients are doing very well nowadays, and even with a diagnosis of cancer, they can potentially live for many years,” Anne Chiang, MD, PhD, from the Smilow Cancer Network, New Haven, Connecticut, told Medscape Medical News in a recent interview.

Thus far, even in hard-hit New York City, fears that cancer patients may not be receiving appropriate care have not materialized, according to Mark Robson, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center (MSKCC). “I would emphasize that cancer patients are ABSOLUTELY getting the care they need, including patients with metastatic disease,” he recently tweeted. “NOONE at @sloan_kettering (or anywhere else) is being ‘triaged’ because of advanced cancer. Period.”

Robson told Medscape Medical News that although MSKCC continues to provide oncology care to patients with cancer, “we are [also] treating them if they develop COVID. ... I am trying to help pivot the institution towards care in this setting.”

He said he agrees with Craig Spencer, MD, MPH, director of global health in emergency medicine at the New York–Presbyterian/Columbia University Medical Center, who recently tweeted, “If you need a ventilator, you get a ventilator. Let’s be clear – this isn’t being ‘rationed.’ ”

Marron emphasized that an important safeguard against uninformed decision making is appropriate planning. For hospitalized patients, this means oncologists who provide treatment should offer information even before it is requested. But he said the “duty to plan” begins long before that.

“Clinicians haven’t always been great at talking about death and long-term outcomes with their patients, but this really cranks up the importance of having those conversations, and having them early, even though it’s incredibly hard. If someone has expressed that they would never want to be put on a ventilator, it’s important now even more so that is made clear,” he said.

He said early responses to the ASCO statement suggest that it has calmed some concerns in the oncology community, “but it still remains to be seen whether individual institutions will take this to heart, because this unto itself cannot enforce anything – it is up to individual institutions. I am hopeful this will get to the people it needs to get to.”

This article first appeared on Medscape.com.

As the coronavirus pandemic has swept across America, so have advisories for social distancing. As of April 2, stay-at-home orders had been given in 38 states and parts of 7 more, affecting about 300 million people. Most of these people have been asked to maintain 6 feet of separation to anyone outside their immediate family and to avoid all avoidable contacts.

Typical hospital medicine patients at an academic hospital, however, traditionally receive visits from their hospitalist, an intern, a resident, and sometimes several medical students, pharmacists, and case managers. At University of California, San Diego, Health, many of these visits would occur during Focused Interdisciplinary Team rounds, with providers moving together in close proximity.

Asymptomatic and presymptomatic spread of coronavirus have been documented, which means distancing is a good idea for everyone. The risks of traditional patient visits during the coronavirus pandemic include spread to both patients (at high risk of complications) and staff (taken out of the workforce during surge times). Even if coronavirus were not a risk, visits to isolation rooms consume PPE, which is in short supply.

In response to the pandemic, UCSD Hospital Medicine drafted guidelines for the reduction of patient contacts. Our slide presentations and written guidelines were then distributed to physicians, nurses, pharmacists, and other staff by our pandemic response command center. Key points include the following:

• Target one in-person MD visit per day for stable patients. This means that attending reexaminations of patients seen by residents, nurse practitioners, physician assistants, and so on would not be done for billing or teaching purposes, only when clinically necessary.
• Use phone or video conferencing for follow-up discussions unless direct patient contact is needed.
• Consider skipping daily exams on patients who do not require them, such as patients awaiting placement or stably receiving long courses of antibiotics. Interview them remotely or from the door instead.
• Conduct team rounds, patient discussions, and handoffs with all members 6 feet apart or by telephone or video. Avoid shared work rooms. Substitute video conferences for in-person meetings. Use EMR embedded messaging to reduce face-to-face discussions.
• Check if a patient is ready for a visit before donning PPE to avoid waste.
• Explain to patients that distancing is being conducted to protect them. In our experience, when patients are asked about distancing, they welcome the changes.

We have also considered that most patient visits are generated by nurses and assistants. To increase distancing and reduce PPE waste, we have encouraged nurses and pharmacists to maximize their use of remote communication with patients and to suggest changes to care plans and come up with creative solutions to reduce traffic. We specifically suggested the following changes to routine care:

• Reduce frequency of taking vital signs, such as just daily or as needed, in stable patients (for example, those awaiting placement).
• Reduce checks for alcohol withdrawal and neurologic status as soon as possible, and stop fingersticks in patients with well-controlled diabetes not receiving insulin.
• Substitute less frequently administered medications where appropriate if doing so would reduce room traffic (such as enoxaparin for heparin, ceftriaxone for cefazolin, naproxen for ibuprofen, or patient-controlled analgesia for as needed morphine).
• Place intravenous pumps in halls if needed – luckily, our situation has not required these measures in San Diego.
• Explore the possibility of increased patient self-management (self-dosed insulin or inhalers) where medically appropriate.
• Eliminate food service and janitorial trips to isolation rooms unless requested by registered nurse.

There are clear downsides to medical distancing for hospital medicine patients. Patients might have delayed diagnosis of new conditions or inadequate management of conditions requiring frequent assessment, such as alcohol withdrawal. Opportunities for miscommunication (either patient-provider or provider-provider) may be increased with distancing. Isolation also comes with emotional costs such as stress and feelings of isolation or abandonment. Given the dynamic nature of the pandemic response, we are continually reevaluating our distancing guidelines to administer the safest and most effective hospital care possible as we approach California’s expected peak coronavirus infection period.

Dr. Jenkins is professor and chair of the Patient Safety Committee in the Division of Hospital Medicine at UCSD. Dr. Seymann is clinical professor and vice chief for academic affairs, UCSD division of hospital medicine. Dr. Horman and Dr. Bell are hospitalists and associate professors of medicine at UC San Diego Health.

As the coronavirus pandemic has swept across America, so have advisories for social distancing. As of April 2, stay-at-home orders had been given in 38 states and parts of 7 more, affecting about 300 million people. Most of these people have been asked to maintain 6 feet of separation to anyone outside their immediate family and to avoid all avoidable contacts.

Typical hospital medicine patients at an academic hospital, however, traditionally receive visits from their hospitalist, an intern, a resident, and sometimes several medical students, pharmacists, and case managers. At University of California, San Diego, Health, many of these visits would occur during Focused Interdisciplinary Team rounds, with providers moving together in close proximity.

Asymptomatic and presymptomatic spread of coronavirus have been documented, which means distancing is a good idea for everyone. The risks of traditional patient visits during the coronavirus pandemic include spread to both patients (at high risk of complications) and staff (taken out of the workforce during surge times). Even if coronavirus were not a risk, visits to isolation rooms consume PPE, which is in short supply.

In response to the pandemic, UCSD Hospital Medicine drafted guidelines for the reduction of patient contacts. Our slide presentations and written guidelines were then distributed to physicians, nurses, pharmacists, and other staff by our pandemic response command center. Key points include the following:

• Target one in-person MD visit per day for stable patients. This means that attending reexaminations of patients seen by residents, nurse practitioners, physician assistants, and so on would not be done for billing or teaching purposes, only when clinically necessary.
• Use phone or video conferencing for follow-up discussions unless direct patient contact is needed.
• Consider skipping daily exams on patients who do not require them, such as patients awaiting placement or stably receiving long courses of antibiotics. Interview them remotely or from the door instead.
• Conduct team rounds, patient discussions, and handoffs with all members 6 feet apart or by telephone or video. Avoid shared work rooms. Substitute video conferences for in-person meetings. Use EMR embedded messaging to reduce face-to-face discussions.
• Check if a patient is ready for a visit before donning PPE to avoid waste.
• Explain to patients that distancing is being conducted to protect them. In our experience, when patients are asked about distancing, they welcome the changes.

We have also considered that most patient visits are generated by nurses and assistants. To increase distancing and reduce PPE waste, we have encouraged nurses and pharmacists to maximize their use of remote communication with patients and to suggest changes to care plans and come up with creative solutions to reduce traffic. We specifically suggested the following changes to routine care:

• Reduce frequency of taking vital signs, such as just daily or as needed, in stable patients (for example, those awaiting placement).
• Reduce checks for alcohol withdrawal and neurologic status as soon as possible, and stop fingersticks in patients with well-controlled diabetes not receiving insulin.
• Substitute less frequently administered medications where appropriate if doing so would reduce room traffic (such as enoxaparin for heparin, ceftriaxone for cefazolin, naproxen for ibuprofen, or patient-controlled analgesia for as needed morphine).
• Place intravenous pumps in halls if needed – luckily, our situation has not required these measures in San Diego.
• Explore the possibility of increased patient self-management (self-dosed insulin or inhalers) where medically appropriate.
• Eliminate food service and janitorial trips to isolation rooms unless requested by registered nurse.

There are clear downsides to medical distancing for hospital medicine patients. Patients might have delayed diagnosis of new conditions or inadequate management of conditions requiring frequent assessment, such as alcohol withdrawal. Opportunities for miscommunication (either patient-provider or provider-provider) may be increased with distancing. Isolation also comes with emotional costs such as stress and feelings of isolation or abandonment. Given the dynamic nature of the pandemic response, we are continually reevaluating our distancing guidelines to administer the safest and most effective hospital care possible as we approach California’s expected peak coronavirus infection period.

Dr. Jenkins is professor and chair of the Patient Safety Committee in the Division of Hospital Medicine at UCSD. Dr. Seymann is clinical professor and vice chief for academic affairs, UCSD division of hospital medicine. Dr. Horman and Dr. Bell are hospitalists and associate professors of medicine at UC San Diego Health.

As the coronavirus pandemic has swept across America, so have advisories for social distancing. As of April 2, stay-at-home orders had been given in 38 states and parts of 7 more, affecting about 300 million people. Most of these people have been asked to maintain 6 feet of separation to anyone outside their immediate family and to avoid all avoidable contacts.

Typical hospital medicine patients at an academic hospital, however, traditionally receive visits from their hospitalist, an intern, a resident, and sometimes several medical students, pharmacists, and case managers. At University of California, San Diego, Health, many of these visits would occur during Focused Interdisciplinary Team rounds, with providers moving together in close proximity.

Asymptomatic and presymptomatic spread of coronavirus have been documented, which means distancing is a good idea for everyone. The risks of traditional patient visits during the coronavirus pandemic include spread to both patients (at high risk of complications) and staff (taken out of the workforce during surge times). Even if coronavirus were not a risk, visits to isolation rooms consume PPE, which is in short supply.

In response to the pandemic, UCSD Hospital Medicine drafted guidelines for the reduction of patient contacts. Our slide presentations and written guidelines were then distributed to physicians, nurses, pharmacists, and other staff by our pandemic response command center. Key points include the following:

• Target one in-person MD visit per day for stable patients. This means that attending reexaminations of patients seen by residents, nurse practitioners, physician assistants, and so on would not be done for billing or teaching purposes, only when clinically necessary.
• Use phone or video conferencing for follow-up discussions unless direct patient contact is needed.
• Consider skipping daily exams on patients who do not require them, such as patients awaiting placement or stably receiving long courses of antibiotics. Interview them remotely or from the door instead.
• Conduct team rounds, patient discussions, and handoffs with all members 6 feet apart or by telephone or video. Avoid shared work rooms. Substitute video conferences for in-person meetings. Use EMR embedded messaging to reduce face-to-face discussions.
• Check if a patient is ready for a visit before donning PPE to avoid waste.
• Explain to patients that distancing is being conducted to protect them. In our experience, when patients are asked about distancing, they welcome the changes.

We have also considered that most patient visits are generated by nurses and assistants. To increase distancing and reduce PPE waste, we have encouraged nurses and pharmacists to maximize their use of remote communication with patients and to suggest changes to care plans and come up with creative solutions to reduce traffic. We specifically suggested the following changes to routine care:

• Reduce frequency of taking vital signs, such as just daily or as needed, in stable patients (for example, those awaiting placement).
• Reduce checks for alcohol withdrawal and neurologic status as soon as possible, and stop fingersticks in patients with well-controlled diabetes not receiving insulin.
• Substitute less frequently administered medications where appropriate if doing so would reduce room traffic (such as enoxaparin for heparin, ceftriaxone for cefazolin, naproxen for ibuprofen, or patient-controlled analgesia for as needed morphine).
• Place intravenous pumps in halls if needed – luckily, our situation has not required these measures in San Diego.
• Explore the possibility of increased patient self-management (self-dosed insulin or inhalers) where medically appropriate.
• Eliminate food service and janitorial trips to isolation rooms unless requested by registered nurse.

There are clear downsides to medical distancing for hospital medicine patients. Patients might have delayed diagnosis of new conditions or inadequate management of conditions requiring frequent assessment, such as alcohol withdrawal. Opportunities for miscommunication (either patient-provider or provider-provider) may be increased with distancing. Isolation also comes with emotional costs such as stress and feelings of isolation or abandonment. Given the dynamic nature of the pandemic response, we are continually reevaluating our distancing guidelines to administer the safest and most effective hospital care possible as we approach California’s expected peak coronavirus infection period.

Dr. Jenkins is professor and chair of the Patient Safety Committee in the Division of Hospital Medicine at UCSD. Dr. Seymann is clinical professor and vice chief for academic affairs, UCSD division of hospital medicine. Dr. Horman and Dr. Bell are hospitalists and associate professors of medicine at UC San Diego Health.

COVID-19 infection in patients with type 2 diabetes is associated with a greater increase in inflammatory and coagulation markers, compared with COVID-19 patients without diabetes, according to preliminary findings from a retrospective analysis of COVID-19 patients in Wuhan, China.

The results, though preliminary, could help explain why patients with diabetes and COVID-19 are at greater risk for more severe disease and death.

The results also suggest that more severe disease in patients with diabetes may be the result of a cytokine storm, in which the patient’s immune system overreacts to the virus and inflicts collateral damage on its own organs, according to Herbert I. Rettinger, MD, a clinical endocrinologist in Orange County, Calif., and member of the editorial advisory board for Clinical Endocrinology News. “Understanding the mechanism might help us understand the best way to treat,” COVID-19 in patients with diabetes, he said in an interview.

Dr. Rettinger, who was not involved in the research, noted that the study included only 24 patients with diabetes. Nevertheless, the finding of heightened inflammatory and coagulation markers was “fascinating.”

“This is the first paper I’ve seen [suggesting] that. I don’t know if we can extrapolate [the findings] to other populations, but if biomarkers are elevated in patients with COVID-19 and diabetes, then it’s something worth looking into, and to be aware of and cautious of. We need to pay attention to this,” he commented.

The study was led by Weina Guo and Desheng Hu at Huazhong University of Science and Technology in Wuhan, China, and published in Diabetes/Metabolism Research and Reviews.

The sample included 174 patients with COVID-19, who were treated consecutively during Feb. 10-29, 2020, at a single center. The researchers first assigned the patients to one of two groups – those with comorbid diabetes and those without. They further excluded all other comorbidities, focusing only on 26 patients with no comorbidities and 24 with only diabetes as a comorbidity, to remove all other comorbidities as possible confounding factors. Patients in the diabetes group were significantly older than those without diabetes (61 vs. 41 years, P < .01). The mortality rate was 16.5% in patients with diabetes and 0% in those without (P = .03).

COVID-19 patients with diabetes alone as a comorbidity had a greater risk for severe pneumonia, as evidenced by a higher mean CT score, compared with those without diabetes and no other comorbidities (P = .04). Patients with diabetes also had higher measures of release of tissue injury–related enzymes and were at higher risk of uncontrolled inflammation and hypercoagulable state. In particular, they had higher levels of interleukin-6 (13.7 vs. 4.1 pg/mL, respectively; P < .01), C-reactive protein (76.4 vs. 7.43 mg/L; P < .01), serum ferritin (764.8 vs. 128.9 ng/mL; P < .01), and D-dimer (1.16 vs. 0.25 mcg/mL; P < .01).

“It’s noteworthy that, for diseases that can induce a cytokine storm, IL-6 is a very good predictor of disease severity and prognosis, and its expression time is longer than other cytokines ([tumor necrosis factor] and IL-1). In addition, a significant rise in serum ferritin indicates the activation of the monocyte-macrophage system, which is a crucial part of inflammatory storm. These results indicate that patients with diabetes are susceptible to form an inflammatory storm, which eventually lead to rapid deterioration of COVID-19,” the authors wrote.

They also cited previous findings suggesting that coronavirus might exacerbate, or even cause, diabetes by seriously damaging islets (Acta Diabetol. 2010;47[3]:193-9). “Since viral infection may cause sharp fluctuation of the blood glucose levels of diabetes patients, which adversely affect the recovery of patients, there is reason to suspect that diabetes combined with SARS-CoV-2 pneumonia may form a vicious circle,” they wrote.

That’s one more reason to carefully monitor diabetes patients, said Dr. Rettinger. “Those patients who are able to make insulin might not be able to do so with the infection, and that may last a while, and they may require insulin. You want to keep a watch on things, and if oral agents are not working well, you want to go to insulin as quickly as you can. Probably diabetics should be way more careful and maybe visit the emergency department at earlier than a nondiabetic would.”

Raghavendra Mirmira, MD, PhD, who conducts translational research on diabetes and insulin production, said that the finding was not a complete surprise to him. “With a lot of diseases, having diabetes as a comorbidity can mean worse outcomes, and that’s certainly true of influenza. It was true for the other COVID-like illnesses, such as SARS and MERS,” Dr. Mirmira, who was not involved in the research, said in an interview.

If the findings hold up in larger numbers of patients and across multiple centers, they have the potential to inform patient management, said Dr. Mirmira, director of the Translational Research Center in the department of medicine at the University of Chicago. That will be especially true as data from long-term follow-up of become available. Elevated values in some biomarkers might dictate a patient be sent straight to the ICU or dictate admission to the hospital rather than being sent home, or it could assist patient selection for some of the new therapies that physicians hope will become available.

“The more information we get [about] total outcome, the more informed we’d be about who would benefit from some of the therapies that are in clinical trials now,” he said. Still, it will be a challenge to prove causation, because patients with diabetes have unique clinical characteristics that could also be the source of the difference.

Dr. Mirmira noted that patients with diabetes only were 20 years older on average than those with no comorbidities. “It’s really hard to know if what you’re looking at for the worse outcomes for people with diabetes is because they were older, and we know that older people tend to do much worse with COVID than younger people.” Ideally, patients would also be matched by age, but there are not enough data to do that yet.

The study was funded by the China National Natural Science Foundation. The authors reported no conflicts of interest. Dr. Rettinger has no relevant financial disclosures. Dr. Mirmira is on scientific advisory boards for Veralox Therapeutics, Sigilon Therapeutics, the Indiana Biosciences Research Institute, and the Juvenile Diabetes Research Foundation.
 

SOURCE: Guo W et al. Diabetes Metab Res Rev. 2020 Mar 31. doi: 10.1002/dmrr.3319.

COVID-19 infection in patients with type 2 diabetes is associated with a greater increase in inflammatory and coagulation markers, compared with COVID-19 patients without diabetes, according to preliminary findings from a retrospective analysis of COVID-19 patients in Wuhan, China.

The results, though preliminary, could help explain why patients with diabetes and COVID-19 are at greater risk for more severe disease and death.

The results also suggest that more severe disease in patients with diabetes may be the result of a cytokine storm, in which the patient’s immune system overreacts to the virus and inflicts collateral damage on its own organs, according to Herbert I. Rettinger, MD, a clinical endocrinologist in Orange County, Calif., and member of the editorial advisory board for Clinical Endocrinology News. “Understanding the mechanism might help us understand the best way to treat,” COVID-19 in patients with diabetes, he said in an interview.

Dr. Rettinger, who was not involved in the research, noted that the study included only 24 patients with diabetes. Nevertheless, the finding of heightened inflammatory and coagulation markers was “fascinating.”

“This is the first paper I’ve seen [suggesting] that. I don’t know if we can extrapolate [the findings] to other populations, but if biomarkers are elevated in patients with COVID-19 and diabetes, then it’s something worth looking into, and to be aware of and cautious of. We need to pay attention to this,” he commented.

The study was led by Weina Guo and Desheng Hu at Huazhong University of Science and Technology in Wuhan, China, and published in Diabetes/Metabolism Research and Reviews.

The sample included 174 patients with COVID-19, who were treated consecutively during Feb. 10-29, 2020, at a single center. The researchers first assigned the patients to one of two groups – those with comorbid diabetes and those without. They further excluded all other comorbidities, focusing only on 26 patients with no comorbidities and 24 with only diabetes as a comorbidity, to remove all other comorbidities as possible confounding factors. Patients in the diabetes group were significantly older than those without diabetes (61 vs. 41 years, P < .01). The mortality rate was 16.5% in patients with diabetes and 0% in those without (P = .03).

COVID-19 patients with diabetes alone as a comorbidity had a greater risk for severe pneumonia, as evidenced by a higher mean CT score, compared with those without diabetes and no other comorbidities (P = .04). Patients with diabetes also had higher measures of release of tissue injury–related enzymes and were at higher risk of uncontrolled inflammation and hypercoagulable state. In particular, they had higher levels of interleukin-6 (13.7 vs. 4.1 pg/mL, respectively; P < .01), C-reactive protein (76.4 vs. 7.43 mg/L; P < .01), serum ferritin (764.8 vs. 128.9 ng/mL; P < .01), and D-dimer (1.16 vs. 0.25 mcg/mL; P < .01).

“It’s noteworthy that, for diseases that can induce a cytokine storm, IL-6 is a very good predictor of disease severity and prognosis, and its expression time is longer than other cytokines ([tumor necrosis factor] and IL-1). In addition, a significant rise in serum ferritin indicates the activation of the monocyte-macrophage system, which is a crucial part of inflammatory storm. These results indicate that patients with diabetes are susceptible to form an inflammatory storm, which eventually lead to rapid deterioration of COVID-19,” the authors wrote.

They also cited previous findings suggesting that coronavirus might exacerbate, or even cause, diabetes by seriously damaging islets (Acta Diabetol. 2010;47[3]:193-9). “Since viral infection may cause sharp fluctuation of the blood glucose levels of diabetes patients, which adversely affect the recovery of patients, there is reason to suspect that diabetes combined with SARS-CoV-2 pneumonia may form a vicious circle,” they wrote.

That’s one more reason to carefully monitor diabetes patients, said Dr. Rettinger. “Those patients who are able to make insulin might not be able to do so with the infection, and that may last a while, and they may require insulin. You want to keep a watch on things, and if oral agents are not working well, you want to go to insulin as quickly as you can. Probably diabetics should be way more careful and maybe visit the emergency department at earlier than a nondiabetic would.”

Raghavendra Mirmira, MD, PhD, who conducts translational research on diabetes and insulin production, said that the finding was not a complete surprise to him. “With a lot of diseases, having diabetes as a comorbidity can mean worse outcomes, and that’s certainly true of influenza. It was true for the other COVID-like illnesses, such as SARS and MERS,” Dr. Mirmira, who was not involved in the research, said in an interview.

If the findings hold up in larger numbers of patients and across multiple centers, they have the potential to inform patient management, said Dr. Mirmira, director of the Translational Research Center in the department of medicine at the University of Chicago. That will be especially true as data from long-term follow-up of become available. Elevated values in some biomarkers might dictate a patient be sent straight to the ICU or dictate admission to the hospital rather than being sent home, or it could assist patient selection for some of the new therapies that physicians hope will become available.

“The more information we get [about] total outcome, the more informed we’d be about who would benefit from some of the therapies that are in clinical trials now,” he said. Still, it will be a challenge to prove causation, because patients with diabetes have unique clinical characteristics that could also be the source of the difference.

Dr. Mirmira noted that patients with diabetes only were 20 years older on average than those with no comorbidities. “It’s really hard to know if what you’re looking at for the worse outcomes for people with diabetes is because they were older, and we know that older people tend to do much worse with COVID than younger people.” Ideally, patients would also be matched by age, but there are not enough data to do that yet.

The study was funded by the China National Natural Science Foundation. The authors reported no conflicts of interest. Dr. Rettinger has no relevant financial disclosures. Dr. Mirmira is on scientific advisory boards for Veralox Therapeutics, Sigilon Therapeutics, the Indiana Biosciences Research Institute, and the Juvenile Diabetes Research Foundation.
 

SOURCE: Guo W et al. Diabetes Metab Res Rev. 2020 Mar 31. doi: 10.1002/dmrr.3319.

COVID-19 infection in patients with type 2 diabetes is associated with a greater increase in inflammatory and coagulation markers, compared with COVID-19 patients without diabetes, according to preliminary findings from a retrospective analysis of COVID-19 patients in Wuhan, China.

The results, though preliminary, could help explain why patients with diabetes and COVID-19 are at greater risk for more severe disease and death.

The results also suggest that more severe disease in patients with diabetes may be the result of a cytokine storm, in which the patient’s immune system overreacts to the virus and inflicts collateral damage on its own organs, according to Herbert I. Rettinger, MD, a clinical endocrinologist in Orange County, Calif., and member of the editorial advisory board for Clinical Endocrinology News. “Understanding the mechanism might help us understand the best way to treat,” COVID-19 in patients with diabetes, he said in an interview.

Dr. Rettinger, who was not involved in the research, noted that the study included only 24 patients with diabetes. Nevertheless, the finding of heightened inflammatory and coagulation markers was “fascinating.”

“This is the first paper I’ve seen [suggesting] that. I don’t know if we can extrapolate [the findings] to other populations, but if biomarkers are elevated in patients with COVID-19 and diabetes, then it’s something worth looking into, and to be aware of and cautious of. We need to pay attention to this,” he commented.

The study was led by Weina Guo and Desheng Hu at Huazhong University of Science and Technology in Wuhan, China, and published in Diabetes/Metabolism Research and Reviews.

The sample included 174 patients with COVID-19, who were treated consecutively during Feb. 10-29, 2020, at a single center. The researchers first assigned the patients to one of two groups – those with comorbid diabetes and those without. They further excluded all other comorbidities, focusing only on 26 patients with no comorbidities and 24 with only diabetes as a comorbidity, to remove all other comorbidities as possible confounding factors. Patients in the diabetes group were significantly older than those without diabetes (61 vs. 41 years, P < .01). The mortality rate was 16.5% in patients with diabetes and 0% in those without (P = .03).

COVID-19 patients with diabetes alone as a comorbidity had a greater risk for severe pneumonia, as evidenced by a higher mean CT score, compared with those without diabetes and no other comorbidities (P = .04). Patients with diabetes also had higher measures of release of tissue injury–related enzymes and were at higher risk of uncontrolled inflammation and hypercoagulable state. In particular, they had higher levels of interleukin-6 (13.7 vs. 4.1 pg/mL, respectively; P < .01), C-reactive protein (76.4 vs. 7.43 mg/L; P < .01), serum ferritin (764.8 vs. 128.9 ng/mL; P < .01), and D-dimer (1.16 vs. 0.25 mcg/mL; P < .01).

“It’s noteworthy that, for diseases that can induce a cytokine storm, IL-6 is a very good predictor of disease severity and prognosis, and its expression time is longer than other cytokines ([tumor necrosis factor] and IL-1). In addition, a significant rise in serum ferritin indicates the activation of the monocyte-macrophage system, which is a crucial part of inflammatory storm. These results indicate that patients with diabetes are susceptible to form an inflammatory storm, which eventually lead to rapid deterioration of COVID-19,” the authors wrote.

They also cited previous findings suggesting that coronavirus might exacerbate, or even cause, diabetes by seriously damaging islets (Acta Diabetol. 2010;47[3]:193-9). “Since viral infection may cause sharp fluctuation of the blood glucose levels of diabetes patients, which adversely affect the recovery of patients, there is reason to suspect that diabetes combined with SARS-CoV-2 pneumonia may form a vicious circle,” they wrote.

That’s one more reason to carefully monitor diabetes patients, said Dr. Rettinger. “Those patients who are able to make insulin might not be able to do so with the infection, and that may last a while, and they may require insulin. You want to keep a watch on things, and if oral agents are not working well, you want to go to insulin as quickly as you can. Probably diabetics should be way more careful and maybe visit the emergency department at earlier than a nondiabetic would.”

Raghavendra Mirmira, MD, PhD, who conducts translational research on diabetes and insulin production, said that the finding was not a complete surprise to him. “With a lot of diseases, having diabetes as a comorbidity can mean worse outcomes, and that’s certainly true of influenza. It was true for the other COVID-like illnesses, such as SARS and MERS,” Dr. Mirmira, who was not involved in the research, said in an interview.

If the findings hold up in larger numbers of patients and across multiple centers, they have the potential to inform patient management, said Dr. Mirmira, director of the Translational Research Center in the department of medicine at the University of Chicago. That will be especially true as data from long-term follow-up of become available. Elevated values in some biomarkers might dictate a patient be sent straight to the ICU or dictate admission to the hospital rather than being sent home, or it could assist patient selection for some of the new therapies that physicians hope will become available.

“The more information we get [about] total outcome, the more informed we’d be about who would benefit from some of the therapies that are in clinical trials now,” he said. Still, it will be a challenge to prove causation, because patients with diabetes have unique clinical characteristics that could also be the source of the difference.

Dr. Mirmira noted that patients with diabetes only were 20 years older on average than those with no comorbidities. “It’s really hard to know if what you’re looking at for the worse outcomes for people with diabetes is because they were older, and we know that older people tend to do much worse with COVID than younger people.” Ideally, patients would also be matched by age, but there are not enough data to do that yet.

The study was funded by the China National Natural Science Foundation. The authors reported no conflicts of interest. Dr. Rettinger has no relevant financial disclosures. Dr. Mirmira is on scientific advisory boards for Veralox Therapeutics, Sigilon Therapeutics, the Indiana Biosciences Research Institute, and the Juvenile Diabetes Research Foundation.
 

SOURCE: Guo W et al. Diabetes Metab Res Rev. 2020 Mar 31. doi: 10.1002/dmrr.3319.

Hydroxychloroquine, which has been touted without definitive scientific support as a treatment for COVID-19 infection, has special significance for the millions of US military service members and veterans who served in Southwest Asia and other countries with endemic malaria: It’s a critical antimalarial drugs. It’s also needed for US Department of Veterans Affairs (VA) patients with rheumatoid arthritis.

On March 24, the VA Inspector General (IG) surveyed VA medical facilities to determine shortages in equipment as well as “antibiotics, sedatives, pain, and antiviral medications,” although there no known effective treatments for COVID-19. The OIG reported that 12 facilities indicated that they anticipated a shortage of medications, including hydroxychloroquine, lopinavir/ritonavir, IV immunoglobulin, and nebulizer products in the next 14 to 28 days. Facilities in West Haven, CT; Martinsburg, WV; Baltimore, MD; Washington, DC; Durham, NC; Columbia, SC; Tampa, FL; Detroit, MI; Temple, TX; Oklahoma City, OK; Aurora, CO; Seattle, WA; and Phoenix, AZ, all indicated anticipated shortages. At least one facility explicitly worried about access to medications and supplies produced in China and concern about disrupted supply chains may have concerned other facilities as well.

Nevertheless, hydroxychloroquine was at the top of mind both OIG inspectors as well as Veterans Health Administration (VHA) officials. In a formal response to the OIG survey, the VHA asserted: “We object to OIG’s assertions that a 14-day supply of chloroquine or hydroxychloroquine would have any merit. This is both inaccurate and irresponsible. There are active investigations into these drugs and many others, as discussed by Dr. Anthony Fauci. Yet no conclusions have been made on their effectiveness. To insist that a 14 days’ supply of these drugs is appropriate or not appropriate displays this dangerous lack of expertise on COVID-19 and Pandemic response.”

Hydroxychloroquine has been associated with serious adverse effects, such as cardiac arrhythmias and hypoglycemia, and its use against COVID-19 is based, so far, on thin evidence. It has shown promise in a laboratory setting against SARS-CoV-2, the virus that causes COVID-19, and in small studies with patients. Nonetheless, the Food and Drug Administration (FDA) has granted limited emergency authorization for certain uses of chloroquine and hydroxychloroquine against COVID-19. The rapid approval came apparently at the behest of the White House.

Former FDA leaders say the authorization has jeopardized research to learn the drugs’ real value in pandemic patients. They also charge that the decision undermines FDA’s scientific authority because it appears to be reacting to political advocacy. 

Despite the concerns, a run on chloroquine and hydroxychloroquine has been underway. According to a March 20 blog post by Premier, a hospital purchasing organization, orders for chloroquine and hydroxychloroquine jumped “dramatically” between March 1 and March 17, by 3,000% and 260%, respectively. Fortunately, these are older, relatively inexpensive oral drugs, Premier says, which means their manufacturing is “far less complicated” than for other drugs. To offer immediate help, Premier notes, drug makers such as Teva and Bayer have announced they will donate millions of tablets of the drugs to hospitals or the federal government for further testing.

Owing to “extraordinary public interest” in the off-label use of these drugs, numerous state boards of pharmacy have enacted emergency restrictions on the inappropriate dispensing of chloroquine and hydroxychloroquine, says the Quinism Foundation, a nonprofit organization that supports education and research on medical conditions caused by chloroquine and related drugs. And because of the very real potential for substitution of more dangerous quinolines (such as mefloquine) in place of chloroquine and hydroxychloroquine, the foundation recently called on state boards of pharmacy to enact uniform restrictions on the dispensing of all quinoline antimalarial drugs, with the understanding that any emergency use of any of these medications for public health purposes as attempted pandemic countermeasures would be best coordinated nationally through distribution from the Strategic National Stockpile.

In the meantime, research into hydroxychloroquine’s effectiveness is ongoing. “Coming at it from every angle”—that’s how Terry Welch, spokesman for the Walter Reed Army Institute of Research told Task & Purpose the Army is “leveraging specific competencies” to attack the COVID-19 problem. Among other things, WRAIR’s Emerging Infectious Diseases Branch (EIDB) is working to develop a vaccine against COVID-19 infection, including several versions of a novel vaccine candidate that has been tested in humans. WRAIR has also been conducting research into novel treatments, such as drug candidates similar to those successfully developed to treat malaria, and monoclonal antibodies.

WRAI was able to start its anti-COVID-19 research in early January—directly on the heels of the first reported cases of infection—because of the Institute’s history of researching related viruses. “If we hadn’t done that, we’d be weeks behind,” said Dr. Kayvon Modjarrad, director of EIDB.

The National Institutes of Health (NIH) has also begun a clinical trial, the Outcomes Related to COVID-19 treated with hydroxychloroquine among in-patients with symptomatic Diseases (ORCHID) study. The study will enroll more than 500 adults who are hospitalized with COVID-19 or in an emergency department awaiting hospitalization. All patients will continue to receive clinical care; some will be randomly assigned to also receive hydroxychloroquine. The first participants have been enrolled at Vanderbilt University Medical Center, in Nashville, one of the centers in the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network.

In the “urgent race to find effective therapies,” NIH also launched the first clinical trial in the US to evaluate remdesivir, a broad-spectrum antiviral, as a potential treatment for COVID-19.  The trial, which started March 6 at the University of Nebraska Medical Center, is expected to conclude in May. Clinical trials of remdesivir have been ongoing in China, where the virus originated. The NIH study “takes into account” those trial designs. 

Many US hospitals are already using hydroxychloroquine as first-line therapy for COVID-19 patients, despite the lack of supportive clinical evidence. Wesley Self, MD, MPH, lead investigator in the ORCHID trial, says “[D]ata on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”

Not only research is needed, but clear expression of the facts about the drugs. In March, shortly after the president began lauding hydroxychloroquine, a Phoenix man died of cardiac arrest and his wife ended up in critical care after they misguidedly ingested chloroquine phosphate, a chemical used to clean fish tanks.  “[W]e understand that people are trying to find new ways to prevent or treat this virus,” said Dr. Daniel Brooks, medical director of the Banner Poison and Drug Information Center in Phoenix, “but self-medicating is not the way to do so.”

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and one of the main spokespersons for science in the hydroxychloroquine debate, has continued to try to make his concerns clear: “I think we’ve got to be careful that we don’t make that majestic leap to assume this is a knockout drug,” he said in late March. “We still need to do the kinds of studies that definitively prove whether any intervention—not just this one, any intervention—is truly safe and effective.”

Hydroxychloroquine, which has been touted without definitive scientific support as a treatment for COVID-19 infection, has special significance for the millions of US military service members and veterans who served in Southwest Asia and other countries with endemic malaria: It’s a critical antimalarial drugs. It’s also needed for US Department of Veterans Affairs (VA) patients with rheumatoid arthritis.

On March 24, the VA Inspector General (IG) surveyed VA medical facilities to determine shortages in equipment as well as “antibiotics, sedatives, pain, and antiviral medications,” although there no known effective treatments for COVID-19. The OIG reported that 12 facilities indicated that they anticipated a shortage of medications, including hydroxychloroquine, lopinavir/ritonavir, IV immunoglobulin, and nebulizer products in the next 14 to 28 days. Facilities in West Haven, CT; Martinsburg, WV; Baltimore, MD; Washington, DC; Durham, NC; Columbia, SC; Tampa, FL; Detroit, MI; Temple, TX; Oklahoma City, OK; Aurora, CO; Seattle, WA; and Phoenix, AZ, all indicated anticipated shortages. At least one facility explicitly worried about access to medications and supplies produced in China and concern about disrupted supply chains may have concerned other facilities as well.

Nevertheless, hydroxychloroquine was at the top of mind both OIG inspectors as well as Veterans Health Administration (VHA) officials. In a formal response to the OIG survey, the VHA asserted: “We object to OIG’s assertions that a 14-day supply of chloroquine or hydroxychloroquine would have any merit. This is both inaccurate and irresponsible. There are active investigations into these drugs and many others, as discussed by Dr. Anthony Fauci. Yet no conclusions have been made on their effectiveness. To insist that a 14 days’ supply of these drugs is appropriate or not appropriate displays this dangerous lack of expertise on COVID-19 and Pandemic response.”

Hydroxychloroquine has been associated with serious adverse effects, such as cardiac arrhythmias and hypoglycemia, and its use against COVID-19 is based, so far, on thin evidence. It has shown promise in a laboratory setting against SARS-CoV-2, the virus that causes COVID-19, and in small studies with patients. Nonetheless, the Food and Drug Administration (FDA) has granted limited emergency authorization for certain uses of chloroquine and hydroxychloroquine against COVID-19. The rapid approval came apparently at the behest of the White House.

Former FDA leaders say the authorization has jeopardized research to learn the drugs’ real value in pandemic patients. They also charge that the decision undermines FDA’s scientific authority because it appears to be reacting to political advocacy. 

Despite the concerns, a run on chloroquine and hydroxychloroquine has been underway. According to a March 20 blog post by Premier, a hospital purchasing organization, orders for chloroquine and hydroxychloroquine jumped “dramatically” between March 1 and March 17, by 3,000% and 260%, respectively. Fortunately, these are older, relatively inexpensive oral drugs, Premier says, which means their manufacturing is “far less complicated” than for other drugs. To offer immediate help, Premier notes, drug makers such as Teva and Bayer have announced they will donate millions of tablets of the drugs to hospitals or the federal government for further testing.

Owing to “extraordinary public interest” in the off-label use of these drugs, numerous state boards of pharmacy have enacted emergency restrictions on the inappropriate dispensing of chloroquine and hydroxychloroquine, says the Quinism Foundation, a nonprofit organization that supports education and research on medical conditions caused by chloroquine and related drugs. And because of the very real potential for substitution of more dangerous quinolines (such as mefloquine) in place of chloroquine and hydroxychloroquine, the foundation recently called on state boards of pharmacy to enact uniform restrictions on the dispensing of all quinoline antimalarial drugs, with the understanding that any emergency use of any of these medications for public health purposes as attempted pandemic countermeasures would be best coordinated nationally through distribution from the Strategic National Stockpile.

In the meantime, research into hydroxychloroquine’s effectiveness is ongoing. “Coming at it from every angle”—that’s how Terry Welch, spokesman for the Walter Reed Army Institute of Research told Task & Purpose the Army is “leveraging specific competencies” to attack the COVID-19 problem. Among other things, WRAIR’s Emerging Infectious Diseases Branch (EIDB) is working to develop a vaccine against COVID-19 infection, including several versions of a novel vaccine candidate that has been tested in humans. WRAIR has also been conducting research into novel treatments, such as drug candidates similar to those successfully developed to treat malaria, and monoclonal antibodies.

WRAI was able to start its anti-COVID-19 research in early January—directly on the heels of the first reported cases of infection—because of the Institute’s history of researching related viruses. “If we hadn’t done that, we’d be weeks behind,” said Dr. Kayvon Modjarrad, director of EIDB.

The National Institutes of Health (NIH) has also begun a clinical trial, the Outcomes Related to COVID-19 treated with hydroxychloroquine among in-patients with symptomatic Diseases (ORCHID) study. The study will enroll more than 500 adults who are hospitalized with COVID-19 or in an emergency department awaiting hospitalization. All patients will continue to receive clinical care; some will be randomly assigned to also receive hydroxychloroquine. The first participants have been enrolled at Vanderbilt University Medical Center, in Nashville, one of the centers in the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network.

In the “urgent race to find effective therapies,” NIH also launched the first clinical trial in the US to evaluate remdesivir, a broad-spectrum antiviral, as a potential treatment for COVID-19.  The trial, which started March 6 at the University of Nebraska Medical Center, is expected to conclude in May. Clinical trials of remdesivir have been ongoing in China, where the virus originated. The NIH study “takes into account” those trial designs. 

Many US hospitals are already using hydroxychloroquine as first-line therapy for COVID-19 patients, despite the lack of supportive clinical evidence. Wesley Self, MD, MPH, lead investigator in the ORCHID trial, says “[D]ata on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”

Not only research is needed, but clear expression of the facts about the drugs. In March, shortly after the president began lauding hydroxychloroquine, a Phoenix man died of cardiac arrest and his wife ended up in critical care after they misguidedly ingested chloroquine phosphate, a chemical used to clean fish tanks.  “[W]e understand that people are trying to find new ways to prevent or treat this virus,” said Dr. Daniel Brooks, medical director of the Banner Poison and Drug Information Center in Phoenix, “but self-medicating is not the way to do so.”

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and one of the main spokespersons for science in the hydroxychloroquine debate, has continued to try to make his concerns clear: “I think we’ve got to be careful that we don’t make that majestic leap to assume this is a knockout drug,” he said in late March. “We still need to do the kinds of studies that definitively prove whether any intervention—not just this one, any intervention—is truly safe and effective.”

Hydroxychloroquine, which has been touted without definitive scientific support as a treatment for COVID-19 infection, has special significance for the millions of US military service members and veterans who served in Southwest Asia and other countries with endemic malaria: It’s a critical antimalarial drugs. It’s also needed for US Department of Veterans Affairs (VA) patients with rheumatoid arthritis.

On March 24, the VA Inspector General (IG) surveyed VA medical facilities to determine shortages in equipment as well as “antibiotics, sedatives, pain, and antiviral medications,” although there no known effective treatments for COVID-19. The OIG reported that 12 facilities indicated that they anticipated a shortage of medications, including hydroxychloroquine, lopinavir/ritonavir, IV immunoglobulin, and nebulizer products in the next 14 to 28 days. Facilities in West Haven, CT; Martinsburg, WV; Baltimore, MD; Washington, DC; Durham, NC; Columbia, SC; Tampa, FL; Detroit, MI; Temple, TX; Oklahoma City, OK; Aurora, CO; Seattle, WA; and Phoenix, AZ, all indicated anticipated shortages. At least one facility explicitly worried about access to medications and supplies produced in China and concern about disrupted supply chains may have concerned other facilities as well.

Nevertheless, hydroxychloroquine was at the top of mind both OIG inspectors as well as Veterans Health Administration (VHA) officials. In a formal response to the OIG survey, the VHA asserted: “We object to OIG’s assertions that a 14-day supply of chloroquine or hydroxychloroquine would have any merit. This is both inaccurate and irresponsible. There are active investigations into these drugs and many others, as discussed by Dr. Anthony Fauci. Yet no conclusions have been made on their effectiveness. To insist that a 14 days’ supply of these drugs is appropriate or not appropriate displays this dangerous lack of expertise on COVID-19 and Pandemic response.”

Hydroxychloroquine has been associated with serious adverse effects, such as cardiac arrhythmias and hypoglycemia, and its use against COVID-19 is based, so far, on thin evidence. It has shown promise in a laboratory setting against SARS-CoV-2, the virus that causes COVID-19, and in small studies with patients. Nonetheless, the Food and Drug Administration (FDA) has granted limited emergency authorization for certain uses of chloroquine and hydroxychloroquine against COVID-19. The rapid approval came apparently at the behest of the White House.

Former FDA leaders say the authorization has jeopardized research to learn the drugs’ real value in pandemic patients. They also charge that the decision undermines FDA’s scientific authority because it appears to be reacting to political advocacy. 

Despite the concerns, a run on chloroquine and hydroxychloroquine has been underway. According to a March 20 blog post by Premier, a hospital purchasing organization, orders for chloroquine and hydroxychloroquine jumped “dramatically” between March 1 and March 17, by 3,000% and 260%, respectively. Fortunately, these are older, relatively inexpensive oral drugs, Premier says, which means their manufacturing is “far less complicated” than for other drugs. To offer immediate help, Premier notes, drug makers such as Teva and Bayer have announced they will donate millions of tablets of the drugs to hospitals or the federal government for further testing.

Owing to “extraordinary public interest” in the off-label use of these drugs, numerous state boards of pharmacy have enacted emergency restrictions on the inappropriate dispensing of chloroquine and hydroxychloroquine, says the Quinism Foundation, a nonprofit organization that supports education and research on medical conditions caused by chloroquine and related drugs. And because of the very real potential for substitution of more dangerous quinolines (such as mefloquine) in place of chloroquine and hydroxychloroquine, the foundation recently called on state boards of pharmacy to enact uniform restrictions on the dispensing of all quinoline antimalarial drugs, with the understanding that any emergency use of any of these medications for public health purposes as attempted pandemic countermeasures would be best coordinated nationally through distribution from the Strategic National Stockpile.

In the meantime, research into hydroxychloroquine’s effectiveness is ongoing. “Coming at it from every angle”—that’s how Terry Welch, spokesman for the Walter Reed Army Institute of Research told Task & Purpose the Army is “leveraging specific competencies” to attack the COVID-19 problem. Among other things, WRAIR’s Emerging Infectious Diseases Branch (EIDB) is working to develop a vaccine against COVID-19 infection, including several versions of a novel vaccine candidate that has been tested in humans. WRAIR has also been conducting research into novel treatments, such as drug candidates similar to those successfully developed to treat malaria, and monoclonal antibodies.

WRAI was able to start its anti-COVID-19 research in early January—directly on the heels of the first reported cases of infection—because of the Institute’s history of researching related viruses. “If we hadn’t done that, we’d be weeks behind,” said Dr. Kayvon Modjarrad, director of EIDB.

The National Institutes of Health (NIH) has also begun a clinical trial, the Outcomes Related to COVID-19 treated with hydroxychloroquine among in-patients with symptomatic Diseases (ORCHID) study. The study will enroll more than 500 adults who are hospitalized with COVID-19 or in an emergency department awaiting hospitalization. All patients will continue to receive clinical care; some will be randomly assigned to also receive hydroxychloroquine. The first participants have been enrolled at Vanderbilt University Medical Center, in Nashville, one of the centers in the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network.

In the “urgent race to find effective therapies,” NIH also launched the first clinical trial in the US to evaluate remdesivir, a broad-spectrum antiviral, as a potential treatment for COVID-19.  The trial, which started March 6 at the University of Nebraska Medical Center, is expected to conclude in May. Clinical trials of remdesivir have been ongoing in China, where the virus originated. The NIH study “takes into account” those trial designs. 

Many US hospitals are already using hydroxychloroquine as first-line therapy for COVID-19 patients, despite the lack of supportive clinical evidence. Wesley Self, MD, MPH, lead investigator in the ORCHID trial, says “[D]ata on hydroxychloroquine for the treatment of COVID-19 are urgently needed to inform clinical practice.”

Not only research is needed, but clear expression of the facts about the drugs. In March, shortly after the president began lauding hydroxychloroquine, a Phoenix man died of cardiac arrest and his wife ended up in critical care after they misguidedly ingested chloroquine phosphate, a chemical used to clean fish tanks.  “[W]e understand that people are trying to find new ways to prevent or treat this virus,” said Dr. Daniel Brooks, medical director of the Banner Poison and Drug Information Center in Phoenix, “but self-medicating is not the way to do so.”

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and one of the main spokespersons for science in the hydroxychloroquine debate, has continued to try to make his concerns clear: “I think we’ve got to be careful that we don’t make that majestic leap to assume this is a knockout drug,” he said in late March. “We still need to do the kinds of studies that definitively prove whether any intervention—not just this one, any intervention—is truly safe and effective.”

The American Medical Association (AMA) along with scores of specialty and state medical societies are asking the Trump administration to help the nation’s clinicians out with an immediate cash infusion that they say they need to sustain their practices, many of which have been crippled by the COVID-19 crisis.

In an April 7 letter to Secretary of US Department of Health and Human Services (HHS) Alex Azar, the AMA, backed by 137 medical groups, made the case for “immediate financial assistance” from the government for all US physicians and nurse practitioners and physician assistants enrolled in Medicare or Medicaid. These payments would be equal to roughly 1 month’s worth of prepandemic revenue from all payers.

Under the methodology laid out in the letter, HHS would use an individual clinician’s average monthly Medicare payment from October to December 2019 to determine their precrisis monthly revenue.

Because Medicare business generates an average of 35% of practice revenue in most specialties, the letter suggests that HHS triple the monthly Medicare payment to calculate the amount of emergency funding it should provide to each clinician.

The letter acknowledges that this approach wouldn’t work for certain specialties, such as psychiatry, allergy/immunology, obstetrics/gynecology, and pediatrics, which derive far less revenue from Medicare than other specialties do. These physicians’ payouts “should be adjusted upward accordingly,” the letter states.

“Physicians are continuing to put their patients’ needs first to combat this unprecedented public health emergency,” the AMA writes. “We urge you to support them against financial peril while they put their lives and businesses at risk.”

Other Emergency Funding Programs

These disbursements would be separate from the $30 billion in direct provider payments announced on April 7 by Seema Verma, the administrator of the Centers for Medicare and Medicaid Services (CMS). Because these payments are based on Medicare volume, the vast majority of this money is expected to go to hospitals.

The government is also providing financial support to hospitals, physicians, and other clinicians affected by the pandemic through CMS’s accelerated/advance payment program, as reported by Medscape Medical News. Physician practices can apply to receive upfront payments equal to 3 months’ worth of their historical Medicare payments, but they must pay back these loans, starting at 120 days after receiving them.

In addition, providers with less than 500 employees can apply for Small Business Administration (SBA) loans that were authorized by the CURES Act. If they use at least 75% of this money to cover payroll costs, the loans will be forgiven.

Medical leaders defended their request for direct physician relief in excess of what these three government programs are offering.

“From the very beginning, the AMA has been advocating for [financial] support for physician practices,” AMA President Patrice Harris, MD, told Medscape Medical News. “It’s not an either/or, it’s not a choice between hospitals or physician practices, it’s both.”

She made it clear that this applied not only to the direct payments that the CURES Act allocated to healthcare providers, but also to the SBA loans.

“We’ve been pleased to see support through the Small Business Administration, and we know that many practices have applied for loans,” Harris said. “We’ll review this, because physician practices have to be included.”

Thus far, she added, “I haven’t heard of anyone [in a medical practice] who has actually received a loan. We’ll be monitoring that, because that will be key.”

Likewise, Robert Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians (ACP), said he hadn’t heard of any practices receiving SBA loans, although many have applied.

What he has heard is that “people couldn’t even get through the SBA process and the website was freezing up. They also have to find a lender, submit documentation and get approved by the lender. And they’re competing with all the other small businesses” for a finite amount of money.

Doherty said it was unclear how many practices have received advance payments from CMS so far. CMS said it disbursed $34 billion in these payments in the first week of the program. These went to over 17,000 of the more than 25,000 applicants, CMS noted.

The ACP – which joined the AMA in its request to HHS – supports the advanced-payment program, Doherty added, but “a loan is a loan. You have to repay it. It brings in cash now, but it means you don’t have cash a few months from now. That’s different from what we’re recommending, which is an infusion of cash to practices that wouldn’t have to be repaid.”

Another advantage of the AMA-led proposal, he said, is its simplicity. It’s based on data that CMS already has, and it doesn’t require physicians to fill out forms or provide documents.

In contrast, he said, “We don’t think HHS would have the ability to process applications from thousands and thousands of physicians [for direct payments]. To create a situation where they’d have to review applications from physicians for funding out of that [CARES Act] emergency fund is probably almost impossible for HHS to administer effectively.”

Most Practices Need Help

While the medical societies’ letter makes a strong pitch for supporting physicians who are combating COVID-19, Harris and Doherty noted that physicians in all kinds of practice situations desperately need this help.

“We’ve heard from many physician practices that they have trouble making payroll,” Doherty said. “Many of them are not seeking any money out of the practices for themselves right now. They’re just trying to keep their staff employed. And some will shut their doors, unless there’s a significant and immediate infusion of money to them. From a healthcare capacity viewpoint, it’s not going to be to anyone’s benefit to see a substantial number of practices laying off staff or closing up entirely because they don’t have the money coming in to keep the doors open,” he said.

Harris agreed. “We’re hearing from practices large and small all over the country, including solo practices. Even the larger practices are losing revenue,” she pointed out. “They appropriately shut down their offices or reduced their hours. They didn’t want to contribute to the further spread of COVID-19.”

Rural practices and those launched by young physicians are facing especially difficult challenges, Harris added, and some may not make it.

It’s also important for policy makers to look ahead to what lies after the pandemic, she said. “We will come out of this, but when we come out of it there will be a lot of pent-up or unmet need where folks delayed necessary visits. Physicians and practices will have to be ready to go. If practices have to furlough some staff, it’s going to take time to ramp that up. So we’re glad to see support of physician practices so the infrastructure is strong when we start again.”

What happens if HHS turns down the medical societies’ request? “We’re hopeful that the [HHS] secretary will agree to what we’re asking,” Doherty said. While it’s always possible to ask Congress to intervene in the next stimulus bill, he said, that wouldn’t happen fast enough to get the money to physicians when they really need it.

This article first appeared on Medscape.com.

The American Medical Association (AMA) along with scores of specialty and state medical societies are asking the Trump administration to help the nation’s clinicians out with an immediate cash infusion that they say they need to sustain their practices, many of which have been crippled by the COVID-19 crisis.

In an April 7 letter to Secretary of US Department of Health and Human Services (HHS) Alex Azar, the AMA, backed by 137 medical groups, made the case for “immediate financial assistance” from the government for all US physicians and nurse practitioners and physician assistants enrolled in Medicare or Medicaid. These payments would be equal to roughly 1 month’s worth of prepandemic revenue from all payers.

Under the methodology laid out in the letter, HHS would use an individual clinician’s average monthly Medicare payment from October to December 2019 to determine their precrisis monthly revenue.

Because Medicare business generates an average of 35% of practice revenue in most specialties, the letter suggests that HHS triple the monthly Medicare payment to calculate the amount of emergency funding it should provide to each clinician.

The letter acknowledges that this approach wouldn’t work for certain specialties, such as psychiatry, allergy/immunology, obstetrics/gynecology, and pediatrics, which derive far less revenue from Medicare than other specialties do. These physicians’ payouts “should be adjusted upward accordingly,” the letter states.

“Physicians are continuing to put their patients’ needs first to combat this unprecedented public health emergency,” the AMA writes. “We urge you to support them against financial peril while they put their lives and businesses at risk.”

Other Emergency Funding Programs

These disbursements would be separate from the $30 billion in direct provider payments announced on April 7 by Seema Verma, the administrator of the Centers for Medicare and Medicaid Services (CMS). Because these payments are based on Medicare volume, the vast majority of this money is expected to go to hospitals.

The government is also providing financial support to hospitals, physicians, and other clinicians affected by the pandemic through CMS’s accelerated/advance payment program, as reported by Medscape Medical News. Physician practices can apply to receive upfront payments equal to 3 months’ worth of their historical Medicare payments, but they must pay back these loans, starting at 120 days after receiving them.

In addition, providers with less than 500 employees can apply for Small Business Administration (SBA) loans that were authorized by the CURES Act. If they use at least 75% of this money to cover payroll costs, the loans will be forgiven.

Medical leaders defended their request for direct physician relief in excess of what these three government programs are offering.

“From the very beginning, the AMA has been advocating for [financial] support for physician practices,” AMA President Patrice Harris, MD, told Medscape Medical News. “It’s not an either/or, it’s not a choice between hospitals or physician practices, it’s both.”

She made it clear that this applied not only to the direct payments that the CURES Act allocated to healthcare providers, but also to the SBA loans.

“We’ve been pleased to see support through the Small Business Administration, and we know that many practices have applied for loans,” Harris said. “We’ll review this, because physician practices have to be included.”

Thus far, she added, “I haven’t heard of anyone [in a medical practice] who has actually received a loan. We’ll be monitoring that, because that will be key.”

Likewise, Robert Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians (ACP), said he hadn’t heard of any practices receiving SBA loans, although many have applied.

What he has heard is that “people couldn’t even get through the SBA process and the website was freezing up. They also have to find a lender, submit documentation and get approved by the lender. And they’re competing with all the other small businesses” for a finite amount of money.

Doherty said it was unclear how many practices have received advance payments from CMS so far. CMS said it disbursed $34 billion in these payments in the first week of the program. These went to over 17,000 of the more than 25,000 applicants, CMS noted.

The ACP – which joined the AMA in its request to HHS – supports the advanced-payment program, Doherty added, but “a loan is a loan. You have to repay it. It brings in cash now, but it means you don’t have cash a few months from now. That’s different from what we’re recommending, which is an infusion of cash to practices that wouldn’t have to be repaid.”

Another advantage of the AMA-led proposal, he said, is its simplicity. It’s based on data that CMS already has, and it doesn’t require physicians to fill out forms or provide documents.

In contrast, he said, “We don’t think HHS would have the ability to process applications from thousands and thousands of physicians [for direct payments]. To create a situation where they’d have to review applications from physicians for funding out of that [CARES Act] emergency fund is probably almost impossible for HHS to administer effectively.”

Most Practices Need Help

While the medical societies’ letter makes a strong pitch for supporting physicians who are combating COVID-19, Harris and Doherty noted that physicians in all kinds of practice situations desperately need this help.

“We’ve heard from many physician practices that they have trouble making payroll,” Doherty said. “Many of them are not seeking any money out of the practices for themselves right now. They’re just trying to keep their staff employed. And some will shut their doors, unless there’s a significant and immediate infusion of money to them. From a healthcare capacity viewpoint, it’s not going to be to anyone’s benefit to see a substantial number of practices laying off staff or closing up entirely because they don’t have the money coming in to keep the doors open,” he said.

Harris agreed. “We’re hearing from practices large and small all over the country, including solo practices. Even the larger practices are losing revenue,” she pointed out. “They appropriately shut down their offices or reduced their hours. They didn’t want to contribute to the further spread of COVID-19.”

Rural practices and those launched by young physicians are facing especially difficult challenges, Harris added, and some may not make it.

It’s also important for policy makers to look ahead to what lies after the pandemic, she said. “We will come out of this, but when we come out of it there will be a lot of pent-up or unmet need where folks delayed necessary visits. Physicians and practices will have to be ready to go. If practices have to furlough some staff, it’s going to take time to ramp that up. So we’re glad to see support of physician practices so the infrastructure is strong when we start again.”

What happens if HHS turns down the medical societies’ request? “We’re hopeful that the [HHS] secretary will agree to what we’re asking,” Doherty said. While it’s always possible to ask Congress to intervene in the next stimulus bill, he said, that wouldn’t happen fast enough to get the money to physicians when they really need it.

This article first appeared on Medscape.com.

The American Medical Association (AMA) along with scores of specialty and state medical societies are asking the Trump administration to help the nation’s clinicians out with an immediate cash infusion that they say they need to sustain their practices, many of which have been crippled by the COVID-19 crisis.

In an April 7 letter to Secretary of US Department of Health and Human Services (HHS) Alex Azar, the AMA, backed by 137 medical groups, made the case for “immediate financial assistance” from the government for all US physicians and nurse practitioners and physician assistants enrolled in Medicare or Medicaid. These payments would be equal to roughly 1 month’s worth of prepandemic revenue from all payers.

Under the methodology laid out in the letter, HHS would use an individual clinician’s average monthly Medicare payment from October to December 2019 to determine their precrisis monthly revenue.

Because Medicare business generates an average of 35% of practice revenue in most specialties, the letter suggests that HHS triple the monthly Medicare payment to calculate the amount of emergency funding it should provide to each clinician.

The letter acknowledges that this approach wouldn’t work for certain specialties, such as psychiatry, allergy/immunology, obstetrics/gynecology, and pediatrics, which derive far less revenue from Medicare than other specialties do. These physicians’ payouts “should be adjusted upward accordingly,” the letter states.

“Physicians are continuing to put their patients’ needs first to combat this unprecedented public health emergency,” the AMA writes. “We urge you to support them against financial peril while they put their lives and businesses at risk.”

Other Emergency Funding Programs

These disbursements would be separate from the $30 billion in direct provider payments announced on April 7 by Seema Verma, the administrator of the Centers for Medicare and Medicaid Services (CMS). Because these payments are based on Medicare volume, the vast majority of this money is expected to go to hospitals.

The government is also providing financial support to hospitals, physicians, and other clinicians affected by the pandemic through CMS’s accelerated/advance payment program, as reported by Medscape Medical News. Physician practices can apply to receive upfront payments equal to 3 months’ worth of their historical Medicare payments, but they must pay back these loans, starting at 120 days after receiving them.

In addition, providers with less than 500 employees can apply for Small Business Administration (SBA) loans that were authorized by the CURES Act. If they use at least 75% of this money to cover payroll costs, the loans will be forgiven.

Medical leaders defended their request for direct physician relief in excess of what these three government programs are offering.

“From the very beginning, the AMA has been advocating for [financial] support for physician practices,” AMA President Patrice Harris, MD, told Medscape Medical News. “It’s not an either/or, it’s not a choice between hospitals or physician practices, it’s both.”

She made it clear that this applied not only to the direct payments that the CURES Act allocated to healthcare providers, but also to the SBA loans.

“We’ve been pleased to see support through the Small Business Administration, and we know that many practices have applied for loans,” Harris said. “We’ll review this, because physician practices have to be included.”

Thus far, she added, “I haven’t heard of anyone [in a medical practice] who has actually received a loan. We’ll be monitoring that, because that will be key.”

Likewise, Robert Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians (ACP), said he hadn’t heard of any practices receiving SBA loans, although many have applied.

What he has heard is that “people couldn’t even get through the SBA process and the website was freezing up. They also have to find a lender, submit documentation and get approved by the lender. And they’re competing with all the other small businesses” for a finite amount of money.

Doherty said it was unclear how many practices have received advance payments from CMS so far. CMS said it disbursed $34 billion in these payments in the first week of the program. These went to over 17,000 of the more than 25,000 applicants, CMS noted.

The ACP – which joined the AMA in its request to HHS – supports the advanced-payment program, Doherty added, but “a loan is a loan. You have to repay it. It brings in cash now, but it means you don’t have cash a few months from now. That’s different from what we’re recommending, which is an infusion of cash to practices that wouldn’t have to be repaid.”

Another advantage of the AMA-led proposal, he said, is its simplicity. It’s based on data that CMS already has, and it doesn’t require physicians to fill out forms or provide documents.

In contrast, he said, “We don’t think HHS would have the ability to process applications from thousands and thousands of physicians [for direct payments]. To create a situation where they’d have to review applications from physicians for funding out of that [CARES Act] emergency fund is probably almost impossible for HHS to administer effectively.”

Most Practices Need Help

While the medical societies’ letter makes a strong pitch for supporting physicians who are combating COVID-19, Harris and Doherty noted that physicians in all kinds of practice situations desperately need this help.

“We’ve heard from many physician practices that they have trouble making payroll,” Doherty said. “Many of them are not seeking any money out of the practices for themselves right now. They’re just trying to keep their staff employed. And some will shut their doors, unless there’s a significant and immediate infusion of money to them. From a healthcare capacity viewpoint, it’s not going to be to anyone’s benefit to see a substantial number of practices laying off staff or closing up entirely because they don’t have the money coming in to keep the doors open,” he said.

Harris agreed. “We’re hearing from practices large and small all over the country, including solo practices. Even the larger practices are losing revenue,” she pointed out. “They appropriately shut down their offices or reduced their hours. They didn’t want to contribute to the further spread of COVID-19.”

Rural practices and those launched by young physicians are facing especially difficult challenges, Harris added, and some may not make it.

It’s also important for policy makers to look ahead to what lies after the pandemic, she said. “We will come out of this, but when we come out of it there will be a lot of pent-up or unmet need where folks delayed necessary visits. Physicians and practices will have to be ready to go. If practices have to furlough some staff, it’s going to take time to ramp that up. So we’re glad to see support of physician practices so the infrastructure is strong when we start again.”

What happens if HHS turns down the medical societies’ request? “We’re hopeful that the [HHS] secretary will agree to what we’re asking,” Doherty said. While it’s always possible to ask Congress to intervene in the next stimulus bill, he said, that wouldn’t happen fast enough to get the money to physicians when they really need it.

This article first appeared on Medscape.com.

Although conflicting, the available data indicate that SARS-CoV-2 could continue to spread in warmer spring and summer months in the US, according to a new report from the National Academies of Science, Engineering, and Medicine (NAS).

Current data suggest that the novel coronavirus may be transmitted less efficiently in higher temperatures and humidity, but the studies are not conclusive because of poor data quality, confounding factors, and the relatively short existence of the pandemic, which makes it difficult to determine its true course, writes David A. Relman, MD, a member of the NAS’ Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, in a rapid expert consultation letter to the White House Office of Science and Technology Policy on April 7.

A number of factors could influence whether SARS-CoV-2 follows the same seasonal pattern as the influenza virus and other seasonal coronaviruses, which wane during warmer months, writes Relman, a professor of microbiology and immunology at Stanford University in California.

But he pointed out that previous coronavirus strains that have caused serious illness – SARS-CoV and MERS-CoV – “have not demonstrated any evidence of seasonality following their emergence.”

Relman cites an example from the current outbreak: “Given that countries currently in ‘summer’ climates, such as Australia and Iran, are experiencing rapid virus spread, a decrease in cases with increases in humidity and temperature elsewhere should not be assumed…Additional studies as the pandemic unfolds could shed more light on the effects of climate on transmission,” he writes.

And even if SARS-CoV-2 turns out to be less infectious in warmer months, “given the lack of host immunity globally, this reduction in transmission efficiency may not lead to a significant reduction in disease spread without the concomitant adoption of major public health interventions,” writes Relman.

Conflicting Data

Relman cites a handful of studies indicating that, on the one hand, SARS-CoV-2 has declined with increasing humidity and temperatures, but that conversely, infectivity has increased in warmer, more humid climates.

A recent study in China, published on the repository and international journal site SSRN, found that while increased temperatures and humidity decreased the infectivity, “the average R0 (R naught) was still close to 2 at maximum temperatures and humidity in their data set, suggesting that the virus will still spread exponentially at higher temperatures and humidity,” said Relman.

Several other studies found higher growth rates in temperate regions. One study, still in preprint on MedRxiv, looked at 310 geographic regions across 116 countries, and shows an inverse relationship between temperature and humidity and the incidence of COVID-19.

All the available studies so far have significant limitations, including limitation in time and location, confounding factors having to do with geography, access to and the quality of public health and health care systems, human behavior, and the availability of testing, said Relman.

However, he said, “it is useful to note that pandemic influenza strains have not exhibited the typical seasonal pattern of endemic/epidemic strains,” and, regardless of whether they started in a warmer or a cooler month, “all had a peak second wave approximately six months after the emergence in the human population.”

Worrisome Persistence on Masks

Seasonality can also be potentially gauged in the laboratory. Most of the studies on environmental persistence of SARS-CoV-2 have been conducted using virus grown in tissue culture. But that, too, is an imperfect method.

Virus disseminated into the environment from naturally infected humans likely has different survival properties than virus grown in culture, said Relman.

In addition, many labs cannot, or fail to, control and vary relative humidity, the committee letter noted. The aerosol studies so far have used humidity levels of 50% to 65%, which is more favorable to decay, while respiratory fluid is more likely to protect against infectivity, and the 20%-to-40% wintertime indoor humidity in temperate regions is more favorable for virus survival.

Even with these caveats, the committee cited worrisome studies on SARS-CoV-2 survival.

In a study published April 2 online in The Lancet, Hong Kong researchers reported significant reductions in virus in culture starting with temperatures at 37°C (98.6°F) or above.

On surfaces at a room temperature of 22°C (71.6°F) with a relative humidity of 65%, there was no infectious virus on printing paper or tissue papers after just 3 hours. It took 4 days for an infectious level to break down on glass and money, and 7 days for stainless steel and plastic. But after 7 days, investigators found 0.1% of the original inoculum on the outside of a surgical mask.

“The persistence of infectious virus on PPE is concerning,” writes Relman, noting that more studies are needed to guide healthcare workers, especially on what might be used to disinfect personal protective equipment “when they cannot be discarded after single use.”

Chad Roy, PhD, a researcher from Tulane University National Primate Research Center in New Orleans, Louisiana, told Relman by phone that in experiments where the virus was suspended as an aerosol at a temperature of 23°C (73.4° F) and about 50% humidity, SARS-CoV-2 had a longer half-life than the influenza virus, SARS-CoV-1, monkeypox virus, and Mycobacterium tuberculosis.

“This result is also concerning, but quite preliminary,” writes Relman.

This article first appeared on Medscape.com.

Although conflicting, the available data indicate that SARS-CoV-2 could continue to spread in warmer spring and summer months in the US, according to a new report from the National Academies of Science, Engineering, and Medicine (NAS).

Current data suggest that the novel coronavirus may be transmitted less efficiently in higher temperatures and humidity, but the studies are not conclusive because of poor data quality, confounding factors, and the relatively short existence of the pandemic, which makes it difficult to determine its true course, writes David A. Relman, MD, a member of the NAS’ Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, in a rapid expert consultation letter to the White House Office of Science and Technology Policy on April 7.

A number of factors could influence whether SARS-CoV-2 follows the same seasonal pattern as the influenza virus and other seasonal coronaviruses, which wane during warmer months, writes Relman, a professor of microbiology and immunology at Stanford University in California.

But he pointed out that previous coronavirus strains that have caused serious illness – SARS-CoV and MERS-CoV – “have not demonstrated any evidence of seasonality following their emergence.”

Relman cites an example from the current outbreak: “Given that countries currently in ‘summer’ climates, such as Australia and Iran, are experiencing rapid virus spread, a decrease in cases with increases in humidity and temperature elsewhere should not be assumed…Additional studies as the pandemic unfolds could shed more light on the effects of climate on transmission,” he writes.

And even if SARS-CoV-2 turns out to be less infectious in warmer months, “given the lack of host immunity globally, this reduction in transmission efficiency may not lead to a significant reduction in disease spread without the concomitant adoption of major public health interventions,” writes Relman.

Conflicting Data

Relman cites a handful of studies indicating that, on the one hand, SARS-CoV-2 has declined with increasing humidity and temperatures, but that conversely, infectivity has increased in warmer, more humid climates.

A recent study in China, published on the repository and international journal site SSRN, found that while increased temperatures and humidity decreased the infectivity, “the average R0 (R naught) was still close to 2 at maximum temperatures and humidity in their data set, suggesting that the virus will still spread exponentially at higher temperatures and humidity,” said Relman.

Several other studies found higher growth rates in temperate regions. One study, still in preprint on MedRxiv, looked at 310 geographic regions across 116 countries, and shows an inverse relationship between temperature and humidity and the incidence of COVID-19.

All the available studies so far have significant limitations, including limitation in time and location, confounding factors having to do with geography, access to and the quality of public health and health care systems, human behavior, and the availability of testing, said Relman.

However, he said, “it is useful to note that pandemic influenza strains have not exhibited the typical seasonal pattern of endemic/epidemic strains,” and, regardless of whether they started in a warmer or a cooler month, “all had a peak second wave approximately six months after the emergence in the human population.”

Worrisome Persistence on Masks

Seasonality can also be potentially gauged in the laboratory. Most of the studies on environmental persistence of SARS-CoV-2 have been conducted using virus grown in tissue culture. But that, too, is an imperfect method.

Virus disseminated into the environment from naturally infected humans likely has different survival properties than virus grown in culture, said Relman.

In addition, many labs cannot, or fail to, control and vary relative humidity, the committee letter noted. The aerosol studies so far have used humidity levels of 50% to 65%, which is more favorable to decay, while respiratory fluid is more likely to protect against infectivity, and the 20%-to-40% wintertime indoor humidity in temperate regions is more favorable for virus survival.

Even with these caveats, the committee cited worrisome studies on SARS-CoV-2 survival.

In a study published April 2 online in The Lancet, Hong Kong researchers reported significant reductions in virus in culture starting with temperatures at 37°C (98.6°F) or above.

On surfaces at a room temperature of 22°C (71.6°F) with a relative humidity of 65%, there was no infectious virus on printing paper or tissue papers after just 3 hours. It took 4 days for an infectious level to break down on glass and money, and 7 days for stainless steel and plastic. But after 7 days, investigators found 0.1% of the original inoculum on the outside of a surgical mask.

“The persistence of infectious virus on PPE is concerning,” writes Relman, noting that more studies are needed to guide healthcare workers, especially on what might be used to disinfect personal protective equipment “when they cannot be discarded after single use.”

Chad Roy, PhD, a researcher from Tulane University National Primate Research Center in New Orleans, Louisiana, told Relman by phone that in experiments where the virus was suspended as an aerosol at a temperature of 23°C (73.4° F) and about 50% humidity, SARS-CoV-2 had a longer half-life than the influenza virus, SARS-CoV-1, monkeypox virus, and Mycobacterium tuberculosis.

“This result is also concerning, but quite preliminary,” writes Relman.

This article first appeared on Medscape.com.

Although conflicting, the available data indicate that SARS-CoV-2 could continue to spread in warmer spring and summer months in the US, according to a new report from the National Academies of Science, Engineering, and Medicine (NAS).

Current data suggest that the novel coronavirus may be transmitted less efficiently in higher temperatures and humidity, but the studies are not conclusive because of poor data quality, confounding factors, and the relatively short existence of the pandemic, which makes it difficult to determine its true course, writes David A. Relman, MD, a member of the NAS’ Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, in a rapid expert consultation letter to the White House Office of Science and Technology Policy on April 7.

A number of factors could influence whether SARS-CoV-2 follows the same seasonal pattern as the influenza virus and other seasonal coronaviruses, which wane during warmer months, writes Relman, a professor of microbiology and immunology at Stanford University in California.

But he pointed out that previous coronavirus strains that have caused serious illness – SARS-CoV and MERS-CoV – “have not demonstrated any evidence of seasonality following their emergence.”

Relman cites an example from the current outbreak: “Given that countries currently in ‘summer’ climates, such as Australia and Iran, are experiencing rapid virus spread, a decrease in cases with increases in humidity and temperature elsewhere should not be assumed…Additional studies as the pandemic unfolds could shed more light on the effects of climate on transmission,” he writes.

And even if SARS-CoV-2 turns out to be less infectious in warmer months, “given the lack of host immunity globally, this reduction in transmission efficiency may not lead to a significant reduction in disease spread without the concomitant adoption of major public health interventions,” writes Relman.

Conflicting Data

Relman cites a handful of studies indicating that, on the one hand, SARS-CoV-2 has declined with increasing humidity and temperatures, but that conversely, infectivity has increased in warmer, more humid climates.

A recent study in China, published on the repository and international journal site SSRN, found that while increased temperatures and humidity decreased the infectivity, “the average R0 (R naught) was still close to 2 at maximum temperatures and humidity in their data set, suggesting that the virus will still spread exponentially at higher temperatures and humidity,” said Relman.

Several other studies found higher growth rates in temperate regions. One study, still in preprint on MedRxiv, looked at 310 geographic regions across 116 countries, and shows an inverse relationship between temperature and humidity and the incidence of COVID-19.

All the available studies so far have significant limitations, including limitation in time and location, confounding factors having to do with geography, access to and the quality of public health and health care systems, human behavior, and the availability of testing, said Relman.

However, he said, “it is useful to note that pandemic influenza strains have not exhibited the typical seasonal pattern of endemic/epidemic strains,” and, regardless of whether they started in a warmer or a cooler month, “all had a peak second wave approximately six months after the emergence in the human population.”

Worrisome Persistence on Masks

Seasonality can also be potentially gauged in the laboratory. Most of the studies on environmental persistence of SARS-CoV-2 have been conducted using virus grown in tissue culture. But that, too, is an imperfect method.

Virus disseminated into the environment from naturally infected humans likely has different survival properties than virus grown in culture, said Relman.

In addition, many labs cannot, or fail to, control and vary relative humidity, the committee letter noted. The aerosol studies so far have used humidity levels of 50% to 65%, which is more favorable to decay, while respiratory fluid is more likely to protect against infectivity, and the 20%-to-40% wintertime indoor humidity in temperate regions is more favorable for virus survival.

Even with these caveats, the committee cited worrisome studies on SARS-CoV-2 survival.

In a study published April 2 online in The Lancet, Hong Kong researchers reported significant reductions in virus in culture starting with temperatures at 37°C (98.6°F) or above.

On surfaces at a room temperature of 22°C (71.6°F) with a relative humidity of 65%, there was no infectious virus on printing paper or tissue papers after just 3 hours. It took 4 days for an infectious level to break down on glass and money, and 7 days for stainless steel and plastic. But after 7 days, investigators found 0.1% of the original inoculum on the outside of a surgical mask.

“The persistence of infectious virus on PPE is concerning,” writes Relman, noting that more studies are needed to guide healthcare workers, especially on what might be used to disinfect personal protective equipment “when they cannot be discarded after single use.”

Chad Roy, PhD, a researcher from Tulane University National Primate Research Center in New Orleans, Louisiana, told Relman by phone that in experiments where the virus was suspended as an aerosol at a temperature of 23°C (73.4° F) and about 50% humidity, SARS-CoV-2 had a longer half-life than the influenza virus, SARS-CoV-1, monkeypox virus, and Mycobacterium tuberculosis.

“This result is also concerning, but quite preliminary,” writes Relman.

This article first appeared on Medscape.com.

To boost the capacity of frontline clinicians and facilities to fight COVID-19, the Centers for Medicare & Medicaid Services (CMS) on Thursday announced it is temporarily suspending rules to allow physicians to provide telehealth services across state lines, and will permit midlevel practitioners to provide as much care as their state licenses allow.

Physicians can now care for patients at rural hospitals across state lines via phone, radio, or online communications without having to be physically present.

“Remotely located physicians, coordinating with nurse practitioners at rural hospitals, will provide staffs at such facilities additional flexibility to meet the needs of their patients,” a CMS news release said.

At skilled nursing facilities, nurse practitioners will now be able to perform some medical exams that doctors normally conduct on Medicare patients, whether they are COVID-19-related or not, CMS said.

Occupational therapists from home health agencies can now perform initial assessments on certain homebound patients, allowing home health services to start sooner and freeing home health nurses to do more direct patient care.

In addition, hospice nurses will be relieved of hospice aide in-service training tasks so they can spend more time with patients.

“It’s all hands on deck during this crisis,” said CMS Administrator Seema Verma in the press release. “All frontline medical professionals need to be able to work at the highest level they were trained for. CMS is making sure there are no regulatory obstacles to increasing the medical workforce to handle the patient surge during the COVID-19 pandemic.”

The announcement did not directly address the question of whether CMS’ new telemedicine and scope-of-practice policies override state laws. The agency said, “CMS sets and enforces essential quality and safety standards that supplement state scope-of-practice and licensure laws for healthcare workers. CMS has continuously examined its regulations to identify areas where federal requirements may be more stringent than state laws and requirements.”

On March 20, Vice President Pence announced that physicians would be allowed to practice across state lines during the COVID-19 crisis, as reported by Medscape Medical News. Until now, however, CMS had not changed its regulations to allow doctors to conduct telehealth consultations in states other than the ones in which they are licensed.

Other Changes

As part of other rule changes to support the healthcare workforce, CMS said on March 30 that it will pay for more than 80 additional services when furnished via telehealth.

These include emergency department visits, initial skilled nursing facility and discharge visits, and home visits. In addition, the agency said it would cover phone visits with Medicare beneficiaries.

Moreover, while virtual “check-in” visits had previously been limited to established patients, CMS said that doctors would be able to provide these services to both new and established patients.

Among its other regulatory changes in recent weeks, CMS has also temporarily:

• Permitted physicians whose privileges will expire to continue practicing at a hospital, and allowed new physicians to begin working prior to full hospital medical staff/governing body review and approval
• Lifted regulatory requirements regarding hospital personnel qualified to perform specific respiratory care procedures, allowing these professionals to operate to the fullest extent of their licensure
• Waived federal minimum personnel qualifications for clinical nurse specialists, nurse practitioners, and physician assistants so they can work at rural hospitals as long as they meet state licensure requirements
• Allowed physicians and nonphysician practitioners to use telehealth to care for patients at long-term care facilities, rather than having to treat patients at those facilities in person

This article first appeared on Medscape.com.

To boost the capacity of frontline clinicians and facilities to fight COVID-19, the Centers for Medicare & Medicaid Services (CMS) on Thursday announced it is temporarily suspending rules to allow physicians to provide telehealth services across state lines, and will permit midlevel practitioners to provide as much care as their state licenses allow.

Physicians can now care for patients at rural hospitals across state lines via phone, radio, or online communications without having to be physically present.

“Remotely located physicians, coordinating with nurse practitioners at rural hospitals, will provide staffs at such facilities additional flexibility to meet the needs of their patients,” a CMS news release said.

At skilled nursing facilities, nurse practitioners will now be able to perform some medical exams that doctors normally conduct on Medicare patients, whether they are COVID-19-related or not, CMS said.

Occupational therapists from home health agencies can now perform initial assessments on certain homebound patients, allowing home health services to start sooner and freeing home health nurses to do more direct patient care.

In addition, hospice nurses will be relieved of hospice aide in-service training tasks so they can spend more time with patients.

“It’s all hands on deck during this crisis,” said CMS Administrator Seema Verma in the press release. “All frontline medical professionals need to be able to work at the highest level they were trained for. CMS is making sure there are no regulatory obstacles to increasing the medical workforce to handle the patient surge during the COVID-19 pandemic.”

The announcement did not directly address the question of whether CMS’ new telemedicine and scope-of-practice policies override state laws. The agency said, “CMS sets and enforces essential quality and safety standards that supplement state scope-of-practice and licensure laws for healthcare workers. CMS has continuously examined its regulations to identify areas where federal requirements may be more stringent than state laws and requirements.”

On March 20, Vice President Pence announced that physicians would be allowed to practice across state lines during the COVID-19 crisis, as reported by Medscape Medical News. Until now, however, CMS had not changed its regulations to allow doctors to conduct telehealth consultations in states other than the ones in which they are licensed.

Other Changes

As part of other rule changes to support the healthcare workforce, CMS said on March 30 that it will pay for more than 80 additional services when furnished via telehealth.

These include emergency department visits, initial skilled nursing facility and discharge visits, and home visits. In addition, the agency said it would cover phone visits with Medicare beneficiaries.

Moreover, while virtual “check-in” visits had previously been limited to established patients, CMS said that doctors would be able to provide these services to both new and established patients.

Among its other regulatory changes in recent weeks, CMS has also temporarily:

• Permitted physicians whose privileges will expire to continue practicing at a hospital, and allowed new physicians to begin working prior to full hospital medical staff/governing body review and approval
• Lifted regulatory requirements regarding hospital personnel qualified to perform specific respiratory care procedures, allowing these professionals to operate to the fullest extent of their licensure
• Waived federal minimum personnel qualifications for clinical nurse specialists, nurse practitioners, and physician assistants so they can work at rural hospitals as long as they meet state licensure requirements
• Allowed physicians and nonphysician practitioners to use telehealth to care for patients at long-term care facilities, rather than having to treat patients at those facilities in person

This article first appeared on Medscape.com.

To boost the capacity of frontline clinicians and facilities to fight COVID-19, the Centers for Medicare & Medicaid Services (CMS) on Thursday announced it is temporarily suspending rules to allow physicians to provide telehealth services across state lines, and will permit midlevel practitioners to provide as much care as their state licenses allow.

Physicians can now care for patients at rural hospitals across state lines via phone, radio, or online communications without having to be physically present.

“Remotely located physicians, coordinating with nurse practitioners at rural hospitals, will provide staffs at such facilities additional flexibility to meet the needs of their patients,” a CMS news release said.

At skilled nursing facilities, nurse practitioners will now be able to perform some medical exams that doctors normally conduct on Medicare patients, whether they are COVID-19-related or not, CMS said.

Occupational therapists from home health agencies can now perform initial assessments on certain homebound patients, allowing home health services to start sooner and freeing home health nurses to do more direct patient care.

In addition, hospice nurses will be relieved of hospice aide in-service training tasks so they can spend more time with patients.

“It’s all hands on deck during this crisis,” said CMS Administrator Seema Verma in the press release. “All frontline medical professionals need to be able to work at the highest level they were trained for. CMS is making sure there are no regulatory obstacles to increasing the medical workforce to handle the patient surge during the COVID-19 pandemic.”

The announcement did not directly address the question of whether CMS’ new telemedicine and scope-of-practice policies override state laws. The agency said, “CMS sets and enforces essential quality and safety standards that supplement state scope-of-practice and licensure laws for healthcare workers. CMS has continuously examined its regulations to identify areas where federal requirements may be more stringent than state laws and requirements.”

On March 20, Vice President Pence announced that physicians would be allowed to practice across state lines during the COVID-19 crisis, as reported by Medscape Medical News. Until now, however, CMS had not changed its regulations to allow doctors to conduct telehealth consultations in states other than the ones in which they are licensed.

Other Changes

As part of other rule changes to support the healthcare workforce, CMS said on March 30 that it will pay for more than 80 additional services when furnished via telehealth.

These include emergency department visits, initial skilled nursing facility and discharge visits, and home visits. In addition, the agency said it would cover phone visits with Medicare beneficiaries.

Moreover, while virtual “check-in” visits had previously been limited to established patients, CMS said that doctors would be able to provide these services to both new and established patients.

Among its other regulatory changes in recent weeks, CMS has also temporarily:

• Permitted physicians whose privileges will expire to continue practicing at a hospital, and allowed new physicians to begin working prior to full hospital medical staff/governing body review and approval
• Lifted regulatory requirements regarding hospital personnel qualified to perform specific respiratory care procedures, allowing these professionals to operate to the fullest extent of their licensure
• Waived federal minimum personnel qualifications for clinical nurse specialists, nurse practitioners, and physician assistants so they can work at rural hospitals as long as they meet state licensure requirements
• Allowed physicians and nonphysician practitioners to use telehealth to care for patients at long-term care facilities, rather than having to treat patients at those facilities in person

This article first appeared on Medscape.com.

New data on the investigational antiviral drug remdesivir (Gilead) suggest clinical improvement in 36 of 53 patients (68%) hospitalized for severe COVID-19, according to a new study published online April 10 in the New England Journal of Medicine.

Courtesy NIAID-RML

But experts are warning that these data come from compassionate use in a wide variety of patients, with no randomization and no control group.

“It is impossible to know the outcome for this relatively small group of patients had they not received remdesivir,” commented Stephen Griffin, PhD, associate professor at the University of Leeds School of Medicine, United Kingdom, who was not involved with the study.

“As the authors point out, a randomized clinical trial is necessary to determine the true effectiveness of this drug,” Griffin added in comments he provided to the Science Media Centre in London. Such trials are underway.

“The data from this paper are almost uninterpretable,” said Stephen Evans, MSc, FRCP, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who provided comments to the Science Media Centre.

Evans notes that the authors describe multiple caveats that limit interpretation of the results, including the small sample size, the relatively short follow-up, missing data, no follow-up on eight patients, and lack of a randomized control group.

Meanwhile, Josh Farkas, MD, who writes the PulmCrit blog, details his criticisms in a piece entitled, “Eleven reasons the NEJM paper on remdesivir reveals nothing.” Beyond the issues the authors list, he points out several more, including cherry picking of patients. “Remdesivir was aggressively sought-after by thousands of patients with COVID-19,” he writes. “Of these patients, 61 ended up receiving the drug. Why did these patients receive medication, out of scores of patients applying to receive it?”

Also, there are no follow-up data for 8 of the 61 patients who received an initial dose of the drug, leaving 53 for the published analysis, continues Farkas, who is an assistant professor of pulmonary and critical care medicine at the University of Vermont in Burlington.

“What happened to these patients? Did they die from anaphylaxis? Did they get well, sign out against medical advice, and go party? This is unknown — but I’m worried that these patients actually didn’t fare so well,” Farkas writes.

Farkas, like Evans and Griffin, concludes that the data are largely unusable. “Until [a randomized controlled trial] is performed, further compassionate use of remdesivir probably isn’t justified,” he writes.
 

Data from Compassionate Use Program

The data in the NEJM article come from a compassionate use program set up by Gilead. The company says it has provided emergency access to remdesivir for several hundred patients in the United States, Europe, and Japan.

The authors, led by Jonathan Grein, MD, from Cedars–Sinai Medical Center, Los Angeles, California, report on 61 patients who received remdesivir as part of this program.

The authors, several of whom are employees of Gilead, note that data on 8 patients could not be analyzed (including 7 patients with no posttreatment data and 1 with a dosing error).

Of the 53 patients whose data were included, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan.

These were patients hospitalized with COVID-19 who had confirmed SARS-CoV-2 infection and had an oxygen saturation of 94% or less while they were breathing ambient air, or who were receiving oxygen support.

Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment.

At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation.

During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 (57%) of 30 patients receiving mechanical ventilation who were extubated.

A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation.

While the authors acknowledge limitations of the data they collected, they nevertheless comment that “comparisons with contemporaneous cohorts from the literature, in whom general care is expected to be consistent with that of our cohort, suggest that remdesivir may have clinical benefit in patients with severe COVID-19.”

“Currently there is no proven treatment for COVID-19. We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” said Grein in a Cedars–Sinai press release. “We look forward to the results of controlled clinical trials to potentially validate these findings.”

Experts are not convinced, however.

“The drug was being used in patients who were severely ill, but reporting on 61 out of several hundred makes it clear that generalizations about the efficacy and safety must be treated with great caution,” said Evans. “There is some evidence suggesting efficacy, but we simply do not know what would have happened to these patients had they not been given the drug.”

“I would say it’s impossible to discern whether there is a treatment effect or not,” said Duncan Richards, MA, DM, FRCP, clinical pharmacologist and professor of clinical therapeutics, University of Oxford, UK. “This is in part due to the mixed patient population, ranging from those needing low dose oxygen, who are more likely to survive anyway, to much more severe cases ... [who] show a much more mixed picture.”

“There are ongoing large international randomized controlled trials with remdesivir — we really need to see those data, “ he said in comments to Science Media Centre. “Safe and effective treatments for COVID-19 are critically needed and should be expedited wherever possible, but it’s important not to compromise on the quality of the research.”

Multiple coauthors are employees of Gilead, the company developing remdesivir. Griffin, Evans, and Farkas have disclosed no relevant financial relationships. Richards consults for GlaxoSmithKline in the field of drug safety. GSK does not manufacture any of the products mentioned.

N Engl J Med. 2020 Apr 10. Full text.

This article first appeared on Medscape.com.

New data on the investigational antiviral drug remdesivir (Gilead) suggest clinical improvement in 36 of 53 patients (68%) hospitalized for severe COVID-19, according to a new study published online April 10 in the New England Journal of Medicine.

Courtesy NIAID-RML

But experts are warning that these data come from compassionate use in a wide variety of patients, with no randomization and no control group.

“It is impossible to know the outcome for this relatively small group of patients had they not received remdesivir,” commented Stephen Griffin, PhD, associate professor at the University of Leeds School of Medicine, United Kingdom, who was not involved with the study.

“As the authors point out, a randomized clinical trial is necessary to determine the true effectiveness of this drug,” Griffin added in comments he provided to the Science Media Centre in London. Such trials are underway.

“The data from this paper are almost uninterpretable,” said Stephen Evans, MSc, FRCP, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who provided comments to the Science Media Centre.

Evans notes that the authors describe multiple caveats that limit interpretation of the results, including the small sample size, the relatively short follow-up, missing data, no follow-up on eight patients, and lack of a randomized control group.

Meanwhile, Josh Farkas, MD, who writes the PulmCrit blog, details his criticisms in a piece entitled, “Eleven reasons the NEJM paper on remdesivir reveals nothing.” Beyond the issues the authors list, he points out several more, including cherry picking of patients. “Remdesivir was aggressively sought-after by thousands of patients with COVID-19,” he writes. “Of these patients, 61 ended up receiving the drug. Why did these patients receive medication, out of scores of patients applying to receive it?”

Also, there are no follow-up data for 8 of the 61 patients who received an initial dose of the drug, leaving 53 for the published analysis, continues Farkas, who is an assistant professor of pulmonary and critical care medicine at the University of Vermont in Burlington.

“What happened to these patients? Did they die from anaphylaxis? Did they get well, sign out against medical advice, and go party? This is unknown — but I’m worried that these patients actually didn’t fare so well,” Farkas writes.

Farkas, like Evans and Griffin, concludes that the data are largely unusable. “Until [a randomized controlled trial] is performed, further compassionate use of remdesivir probably isn’t justified,” he writes.
 

Data from Compassionate Use Program

The data in the NEJM article come from a compassionate use program set up by Gilead. The company says it has provided emergency access to remdesivir for several hundred patients in the United States, Europe, and Japan.

The authors, led by Jonathan Grein, MD, from Cedars–Sinai Medical Center, Los Angeles, California, report on 61 patients who received remdesivir as part of this program.

The authors, several of whom are employees of Gilead, note that data on 8 patients could not be analyzed (including 7 patients with no posttreatment data and 1 with a dosing error).

Of the 53 patients whose data were included, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan.

These were patients hospitalized with COVID-19 who had confirmed SARS-CoV-2 infection and had an oxygen saturation of 94% or less while they were breathing ambient air, or who were receiving oxygen support.

Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment.

At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation.

During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 (57%) of 30 patients receiving mechanical ventilation who were extubated.

A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation.

While the authors acknowledge limitations of the data they collected, they nevertheless comment that “comparisons with contemporaneous cohorts from the literature, in whom general care is expected to be consistent with that of our cohort, suggest that remdesivir may have clinical benefit in patients with severe COVID-19.”

“Currently there is no proven treatment for COVID-19. We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” said Grein in a Cedars–Sinai press release. “We look forward to the results of controlled clinical trials to potentially validate these findings.”

Experts are not convinced, however.

“The drug was being used in patients who were severely ill, but reporting on 61 out of several hundred makes it clear that generalizations about the efficacy and safety must be treated with great caution,” said Evans. “There is some evidence suggesting efficacy, but we simply do not know what would have happened to these patients had they not been given the drug.”

“I would say it’s impossible to discern whether there is a treatment effect or not,” said Duncan Richards, MA, DM, FRCP, clinical pharmacologist and professor of clinical therapeutics, University of Oxford, UK. “This is in part due to the mixed patient population, ranging from those needing low dose oxygen, who are more likely to survive anyway, to much more severe cases ... [who] show a much more mixed picture.”

“There are ongoing large international randomized controlled trials with remdesivir — we really need to see those data, “ he said in comments to Science Media Centre. “Safe and effective treatments for COVID-19 are critically needed and should be expedited wherever possible, but it’s important not to compromise on the quality of the research.”

Multiple coauthors are employees of Gilead, the company developing remdesivir. Griffin, Evans, and Farkas have disclosed no relevant financial relationships. Richards consults for GlaxoSmithKline in the field of drug safety. GSK does not manufacture any of the products mentioned.

N Engl J Med. 2020 Apr 10. Full text.

This article first appeared on Medscape.com.

New data on the investigational antiviral drug remdesivir (Gilead) suggest clinical improvement in 36 of 53 patients (68%) hospitalized for severe COVID-19, according to a new study published online April 10 in the New England Journal of Medicine.

Courtesy NIAID-RML

But experts are warning that these data come from compassionate use in a wide variety of patients, with no randomization and no control group.

“It is impossible to know the outcome for this relatively small group of patients had they not received remdesivir,” commented Stephen Griffin, PhD, associate professor at the University of Leeds School of Medicine, United Kingdom, who was not involved with the study.

“As the authors point out, a randomized clinical trial is necessary to determine the true effectiveness of this drug,” Griffin added in comments he provided to the Science Media Centre in London. Such trials are underway.

“The data from this paper are almost uninterpretable,” said Stephen Evans, MSc, FRCP, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who provided comments to the Science Media Centre.

Evans notes that the authors describe multiple caveats that limit interpretation of the results, including the small sample size, the relatively short follow-up, missing data, no follow-up on eight patients, and lack of a randomized control group.

Meanwhile, Josh Farkas, MD, who writes the PulmCrit blog, details his criticisms in a piece entitled, “Eleven reasons the NEJM paper on remdesivir reveals nothing.” Beyond the issues the authors list, he points out several more, including cherry picking of patients. “Remdesivir was aggressively sought-after by thousands of patients with COVID-19,” he writes. “Of these patients, 61 ended up receiving the drug. Why did these patients receive medication, out of scores of patients applying to receive it?”

Also, there are no follow-up data for 8 of the 61 patients who received an initial dose of the drug, leaving 53 for the published analysis, continues Farkas, who is an assistant professor of pulmonary and critical care medicine at the University of Vermont in Burlington.

“What happened to these patients? Did they die from anaphylaxis? Did they get well, sign out against medical advice, and go party? This is unknown — but I’m worried that these patients actually didn’t fare so well,” Farkas writes.

Farkas, like Evans and Griffin, concludes that the data are largely unusable. “Until [a randomized controlled trial] is performed, further compassionate use of remdesivir probably isn’t justified,” he writes.
 

Data from Compassionate Use Program

The data in the NEJM article come from a compassionate use program set up by Gilead. The company says it has provided emergency access to remdesivir for several hundred patients in the United States, Europe, and Japan.

The authors, led by Jonathan Grein, MD, from Cedars–Sinai Medical Center, Los Angeles, California, report on 61 patients who received remdesivir as part of this program.

The authors, several of whom are employees of Gilead, note that data on 8 patients could not be analyzed (including 7 patients with no posttreatment data and 1 with a dosing error).

Of the 53 patients whose data were included, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan.

These were patients hospitalized with COVID-19 who had confirmed SARS-CoV-2 infection and had an oxygen saturation of 94% or less while they were breathing ambient air, or who were receiving oxygen support.

Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment.

At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation.

During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 (57%) of 30 patients receiving mechanical ventilation who were extubated.

A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation.

While the authors acknowledge limitations of the data they collected, they nevertheless comment that “comparisons with contemporaneous cohorts from the literature, in whom general care is expected to be consistent with that of our cohort, suggest that remdesivir may have clinical benefit in patients with severe COVID-19.”

“Currently there is no proven treatment for COVID-19. We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” said Grein in a Cedars–Sinai press release. “We look forward to the results of controlled clinical trials to potentially validate these findings.”

Experts are not convinced, however.

“The drug was being used in patients who were severely ill, but reporting on 61 out of several hundred makes it clear that generalizations about the efficacy and safety must be treated with great caution,” said Evans. “There is some evidence suggesting efficacy, but we simply do not know what would have happened to these patients had they not been given the drug.”

“I would say it’s impossible to discern whether there is a treatment effect or not,” said Duncan Richards, MA, DM, FRCP, clinical pharmacologist and professor of clinical therapeutics, University of Oxford, UK. “This is in part due to the mixed patient population, ranging from those needing low dose oxygen, who are more likely to survive anyway, to much more severe cases ... [who] show a much more mixed picture.”

“There are ongoing large international randomized controlled trials with remdesivir — we really need to see those data, “ he said in comments to Science Media Centre. “Safe and effective treatments for COVID-19 are critically needed and should be expedited wherever possible, but it’s important not to compromise on the quality of the research.”

Multiple coauthors are employees of Gilead, the company developing remdesivir. Griffin, Evans, and Farkas have disclosed no relevant financial relationships. Richards consults for GlaxoSmithKline in the field of drug safety. GSK does not manufacture any of the products mentioned.

N Engl J Med. 2020 Apr 10. Full text.

This article first appeared on Medscape.com.

While there are still no proven treatments for COVID-19, the antiviral medication remdesivir is currently the most promising therapy under investigation, according to authors of a recent review covering nearly 300 active clinical treatment trials underway for the disease.

Remdesivir, which has potent in vitro activity against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is not approved by the Food and Drug Administration and is currently being tested in randomized trials, according to the review authors, led by James M. Sanders, PhD, of the department of pharmacy at University of Texas Southwestern Medical Center in Dallas.

By contrast, oseltamivir has not demonstrated efficacy against the virus, corticosteroids are not recommended, and promising data from a small French hydroxychloroquine study are balanced by “several major limitations” including small sample size and exclusion of early dropouts from the analysis, among others, Dr. Sanders and coauthors said in their report.

“These limitations coupled with concerns of additive cardiotoxicity with combination therapy [i.e., hydroxychloroquine with azithromycin] do not support adoption of this regimen without additional studies,” the researchers wrote. Their report is in JAMA.

Dr. Sanders and colleagues identified 291 COVID-19–specific studies listed in ClinicalTrials.gov through April 2, including 29 placebo-controlled trials.

This might represent just a sliver of the treatments that could combat COVID-19, according to the researchers, who said more than 3,000 small-molecule drug candidates with potential activity against human coronaviruses have been identified.

“This large amount of potential agents will hopefully yield more candidate therapeutics in the race to find effective treatments or preventive strategies against COVID-19,” said Dr. Sanders and coauthors.
 

Remdesivir for COVID-19

Remdesivir, an investigational nucleotide analog, is one promising agent because of its broad-spectrum and potent activity against SARS-CoV-2 and other novel coronaviruses, they said, adding that phase 1 trials demonstrated the drug was well tolerated without observed liver or kidney toxicity.

There have been “successful” case reports of remdesivir use in COVID-19, and at least five ongoing clinical trials are evaluating the drug’s safety and antiviral activity in this disease. Among those studies is a National Institutes of Health–sponsored adaptive, randomized, placebo-controlled trial that will provide data on the use of remdesivir versus supportive care.

“As the results from randomized controlled trials are anticipated, inclusion of this agent for treatment of COVID-19 may be considered,” Dr. Sanders and colleagues wrote in their report. To date, remdesivir remains investigational and needs to be obtained via compassionate use, through expanded access, or by participating in a clinical trial, they added.

Hydroxychloroquine and chloroquine

Among the published hydroxychloroquine studies is a “promising” 36-patient open-label nonrandomized French study, in which the antimalarial agent given every 8 hours improved virologic clearance by day 6 versus controls (70% vs. 12.5%, respectively), the review authors said. Moreover, viral clearance was 100% for 6 patients who received hydroxychloroquine plus azithromycin, compared to 57% (8 of 14) for patients treated with hydroxychloroquine alone. However, that study had several important limitations, including the small sample size, variable viral loads at baseline between groups, and a lack of safety and clinical outcomes reporting, according to the investigators. Moreover, six patients in the hydroxychloroquine group were taken out of the analysis because of early treatment stoppage due to medical intolerance or critical illness, the authors noted.

One prospective study including 30 patients in China demonstrated no difference in virologic outcomes for patients randomized to hydroxychloroquine plus standard of care versus standard of care alone, they added. There is also a case series of more than 100 patients with COVID-19 that reportedly improved viral clearance and reduced disease progression, though they said results haven’t been published or presented beyond a news briefing in China.

Randomized, controlled trials of chloroquine and hydroxychloroquine for COVID-19 treatment are underway, and studies are planned or enrolling to look at chloroquine prophylaxis in health care personnel and hydroxychloroquine for postexposure prophylaxis, authors said.

In results from one of those randomized trials, just reported, a higher dose of chloroquine was associated with a cardiac adverse event and an increased mortality risk, leading to the closure of that study arm. In the parallel, double-blinded, phase IIb clinical trial, patients in Brazil with SARS-CoV-2 infection received low or high doses of chloroquine plus ceftriaxone and azithromycin. According to the preprint publication, a higher rate of heart rate–corrected QT interval (QTc) prolongation and a “trend toward higher lethality” was observed in the high-dose group, leading investigators to “strongly recommend” the higher dose be abandoned.

“No apparent benefit of chloroquine was seen regarding lethality in our patients so far, but we will still enroll patients in the low chloroquine dose group to complete the originally planned sample size,” said investigators of the study, which at the time of the report had enrolled 81 out of an anticipated 440 patients.
 

Other COVID-19 pharmacologic therapies under study

Treatments of note in the review included the following:

• Tocilizumab. This monoclonal antibody IL-6 receptor antagonist, approved by the FDA for treatment of rheumatoid arthritis and for cytokine release syndrome related to chimeric antigen receptor (CAR) T-cell therapy, has yielded success in small series of patients with severe cases of COVID-19, according to authors. In one 21-patient report, 91% had clinical improvement, usually after a single dose. In China, tocilizumab is included in COVID-19 treatment guidelines, and several randomized clinical trials are underway in China including patients with COVID-19 with severe pneumonia.
• Immunoglobulin therapy. Antibodies from recovered COVID-19 patients could help with free virus and infected cell immune clearance, the authors said, adding that further studies are warranted beyond a few small published case series that suggest promise. Furthermore, on March 24 the FDA released guidance for screening donors for COVID-19 convalescent plasma and on emergency investigational new drug applications based on this modality.

• Lopinavir/ritonavir. Despite demonstrated in vitro activity against other novel coronaviruses, there is no published in vitro data for lopinavir/ritonavir in SARS-CoV-2, and likely a “limited role” for this combination anticipated in treating COVID-19, according to the review authors. In an open-label randomized clinical trial published in the New England Journal of Medicine (2020 Mar 18. doi: 10.1056/NEJMoa2001282), there were no differences in clinical improvement, viral clearance, or mortality for antiviral treatment versus standard care. Delayed treatment initiation may explain the ineffectiveness, though a subgroup analysis didn’t show a shorter time to clinical improvement for those who got the treatment earlier.

• Ribavirin. Likewise, this antiviral medication has efficacy and safety data suggesting “limited value” for treatment of COVID-19. Treatment of SARS yielded “inconclusive results” for ribavirin, which was also associated with substantial toxicity that included hemolytic anemia in 60% of SARS patients.
• Oseltamivir. While it may treat influenza, it has no documented activity against SARS-CoV-2 in vitro: “This agent has no role in the management of COVID-19 once influenza has been excluded,” said Dr. Sanders and coauthors.
• Corticosteroids. They could decrease inflammatory responses in the lung, but they could also lead to delays in viral clearance and increases in secondary infection risk. Guidelines for COVID-19 say to avoid corticosteroids, and the authors of the review concur, saying that potential harms and lack of proven benefit mean they usually should not be used outside of a randomized clinical trial setting.
• Vaccines. Clearly, vaccines represent the “most effective long-term strategy” to prevent future COVID-19 outbreaks, though at least 12-18 months would be required until vaccines can be widely deployed, authors said.

Dr. Sanders reported no potential conflicts. Senior author James B. Cutrell, MD, also of the University of Texas Southwestern Medical Center, reported nonfinancial support from Gilead and Regeneron outside of the study. No other authors reported disclosures.

While there are still no proven treatments for COVID-19, the antiviral medication remdesivir is currently the most promising therapy under investigation, according to authors of a recent review covering nearly 300 active clinical treatment trials underway for the disease.

Remdesivir, which has potent in vitro activity against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is not approved by the Food and Drug Administration and is currently being tested in randomized trials, according to the review authors, led by James M. Sanders, PhD, of the department of pharmacy at University of Texas Southwestern Medical Center in Dallas.

By contrast, oseltamivir has not demonstrated efficacy against the virus, corticosteroids are not recommended, and promising data from a small French hydroxychloroquine study are balanced by “several major limitations” including small sample size and exclusion of early dropouts from the analysis, among others, Dr. Sanders and coauthors said in their report.

“These limitations coupled with concerns of additive cardiotoxicity with combination therapy [i.e., hydroxychloroquine with azithromycin] do not support adoption of this regimen without additional studies,” the researchers wrote. Their report is in JAMA.

Dr. Sanders and colleagues identified 291 COVID-19–specific studies listed in ClinicalTrials.gov through April 2, including 29 placebo-controlled trials.

This might represent just a sliver of the treatments that could combat COVID-19, according to the researchers, who said more than 3,000 small-molecule drug candidates with potential activity against human coronaviruses have been identified.

“This large amount of potential agents will hopefully yield more candidate therapeutics in the race to find effective treatments or preventive strategies against COVID-19,” said Dr. Sanders and coauthors.
 

Remdesivir for COVID-19

Remdesivir, an investigational nucleotide analog, is one promising agent because of its broad-spectrum and potent activity against SARS-CoV-2 and other novel coronaviruses, they said, adding that phase 1 trials demonstrated the drug was well tolerated without observed liver or kidney toxicity.

There have been “successful” case reports of remdesivir use in COVID-19, and at least five ongoing clinical trials are evaluating the drug’s safety and antiviral activity in this disease. Among those studies is a National Institutes of Health–sponsored adaptive, randomized, placebo-controlled trial that will provide data on the use of remdesivir versus supportive care.

“As the results from randomized controlled trials are anticipated, inclusion of this agent for treatment of COVID-19 may be considered,” Dr. Sanders and colleagues wrote in their report. To date, remdesivir remains investigational and needs to be obtained via compassionate use, through expanded access, or by participating in a clinical trial, they added.

Hydroxychloroquine and chloroquine

Among the published hydroxychloroquine studies is a “promising” 36-patient open-label nonrandomized French study, in which the antimalarial agent given every 8 hours improved virologic clearance by day 6 versus controls (70% vs. 12.5%, respectively), the review authors said. Moreover, viral clearance was 100% for 6 patients who received hydroxychloroquine plus azithromycin, compared to 57% (8 of 14) for patients treated with hydroxychloroquine alone. However, that study had several important limitations, including the small sample size, variable viral loads at baseline between groups, and a lack of safety and clinical outcomes reporting, according to the investigators. Moreover, six patients in the hydroxychloroquine group were taken out of the analysis because of early treatment stoppage due to medical intolerance or critical illness, the authors noted.

One prospective study including 30 patients in China demonstrated no difference in virologic outcomes for patients randomized to hydroxychloroquine plus standard of care versus standard of care alone, they added. There is also a case series of more than 100 patients with COVID-19 that reportedly improved viral clearance and reduced disease progression, though they said results haven’t been published or presented beyond a news briefing in China.

Randomized, controlled trials of chloroquine and hydroxychloroquine for COVID-19 treatment are underway, and studies are planned or enrolling to look at chloroquine prophylaxis in health care personnel and hydroxychloroquine for postexposure prophylaxis, authors said.

In results from one of those randomized trials, just reported, a higher dose of chloroquine was associated with a cardiac adverse event and an increased mortality risk, leading to the closure of that study arm. In the parallel, double-blinded, phase IIb clinical trial, patients in Brazil with SARS-CoV-2 infection received low or high doses of chloroquine plus ceftriaxone and azithromycin. According to the preprint publication, a higher rate of heart rate–corrected QT interval (QTc) prolongation and a “trend toward higher lethality” was observed in the high-dose group, leading investigators to “strongly recommend” the higher dose be abandoned.

“No apparent benefit of chloroquine was seen regarding lethality in our patients so far, but we will still enroll patients in the low chloroquine dose group to complete the originally planned sample size,” said investigators of the study, which at the time of the report had enrolled 81 out of an anticipated 440 patients.
 

Other COVID-19 pharmacologic therapies under study

Treatments of note in the review included the following:

• Tocilizumab. This monoclonal antibody IL-6 receptor antagonist, approved by the FDA for treatment of rheumatoid arthritis and for cytokine release syndrome related to chimeric antigen receptor (CAR) T-cell therapy, has yielded success in small series of patients with severe cases of COVID-19, according to authors. In one 21-patient report, 91% had clinical improvement, usually after a single dose. In China, tocilizumab is included in COVID-19 treatment guidelines, and several randomized clinical trials are underway in China including patients with COVID-19 with severe pneumonia.
• Immunoglobulin therapy. Antibodies from recovered COVID-19 patients could help with free virus and infected cell immune clearance, the authors said, adding that further studies are warranted beyond a few small published case series that suggest promise. Furthermore, on March 24 the FDA released guidance for screening donors for COVID-19 convalescent plasma and on emergency investigational new drug applications based on this modality.

• Lopinavir/ritonavir. Despite demonstrated in vitro activity against other novel coronaviruses, there is no published in vitro data for lopinavir/ritonavir in SARS-CoV-2, and likely a “limited role” for this combination anticipated in treating COVID-19, according to the review authors. In an open-label randomized clinical trial published in the New England Journal of Medicine (2020 Mar 18. doi: 10.1056/NEJMoa2001282), there were no differences in clinical improvement, viral clearance, or mortality for antiviral treatment versus standard care. Delayed treatment initiation may explain the ineffectiveness, though a subgroup analysis didn’t show a shorter time to clinical improvement for those who got the treatment earlier.

• Ribavirin. Likewise, this antiviral medication has efficacy and safety data suggesting “limited value” for treatment of COVID-19. Treatment of SARS yielded “inconclusive results” for ribavirin, which was also associated with substantial toxicity that included hemolytic anemia in 60% of SARS patients.
• Oseltamivir. While it may treat influenza, it has no documented activity against SARS-CoV-2 in vitro: “This agent has no role in the management of COVID-19 once influenza has been excluded,” said Dr. Sanders and coauthors.
• Corticosteroids. They could decrease inflammatory responses in the lung, but they could also lead to delays in viral clearance and increases in secondary infection risk. Guidelines for COVID-19 say to avoid corticosteroids, and the authors of the review concur, saying that potential harms and lack of proven benefit mean they usually should not be used outside of a randomized clinical trial setting.
• Vaccines. Clearly, vaccines represent the “most effective long-term strategy” to prevent future COVID-19 outbreaks, though at least 12-18 months would be required until vaccines can be widely deployed, authors said.

Dr. Sanders reported no potential conflicts. Senior author James B. Cutrell, MD, also of the University of Texas Southwestern Medical Center, reported nonfinancial support from Gilead and Regeneron outside of the study. No other authors reported disclosures.

While there are still no proven treatments for COVID-19, the antiviral medication remdesivir is currently the most promising therapy under investigation, according to authors of a recent review covering nearly 300 active clinical treatment trials underway for the disease.

Remdesivir, which has potent in vitro activity against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is not approved by the Food and Drug Administration and is currently being tested in randomized trials, according to the review authors, led by James M. Sanders, PhD, of the department of pharmacy at University of Texas Southwestern Medical Center in Dallas.

By contrast, oseltamivir has not demonstrated efficacy against the virus, corticosteroids are not recommended, and promising data from a small French hydroxychloroquine study are balanced by “several major limitations” including small sample size and exclusion of early dropouts from the analysis, among others, Dr. Sanders and coauthors said in their report.

“These limitations coupled with concerns of additive cardiotoxicity with combination therapy [i.e., hydroxychloroquine with azithromycin] do not support adoption of this regimen without additional studies,” the researchers wrote. Their report is in JAMA.

Dr. Sanders and colleagues identified 291 COVID-19–specific studies listed in ClinicalTrials.gov through April 2, including 29 placebo-controlled trials.

This might represent just a sliver of the treatments that could combat COVID-19, according to the researchers, who said more than 3,000 small-molecule drug candidates with potential activity against human coronaviruses have been identified.

“This large amount of potential agents will hopefully yield more candidate therapeutics in the race to find effective treatments or preventive strategies against COVID-19,” said Dr. Sanders and coauthors.
 

Remdesivir for COVID-19

Remdesivir, an investigational nucleotide analog, is one promising agent because of its broad-spectrum and potent activity against SARS-CoV-2 and other novel coronaviruses, they said, adding that phase 1 trials demonstrated the drug was well tolerated without observed liver or kidney toxicity.

There have been “successful” case reports of remdesivir use in COVID-19, and at least five ongoing clinical trials are evaluating the drug’s safety and antiviral activity in this disease. Among those studies is a National Institutes of Health–sponsored adaptive, randomized, placebo-controlled trial that will provide data on the use of remdesivir versus supportive care.

“As the results from randomized controlled trials are anticipated, inclusion of this agent for treatment of COVID-19 may be considered,” Dr. Sanders and colleagues wrote in their report. To date, remdesivir remains investigational and needs to be obtained via compassionate use, through expanded access, or by participating in a clinical trial, they added.

Hydroxychloroquine and chloroquine

Among the published hydroxychloroquine studies is a “promising” 36-patient open-label nonrandomized French study, in which the antimalarial agent given every 8 hours improved virologic clearance by day 6 versus controls (70% vs. 12.5%, respectively), the review authors said. Moreover, viral clearance was 100% for 6 patients who received hydroxychloroquine plus azithromycin, compared to 57% (8 of 14) for patients treated with hydroxychloroquine alone. However, that study had several important limitations, including the small sample size, variable viral loads at baseline between groups, and a lack of safety and clinical outcomes reporting, according to the investigators. Moreover, six patients in the hydroxychloroquine group were taken out of the analysis because of early treatment stoppage due to medical intolerance or critical illness, the authors noted.

One prospective study including 30 patients in China demonstrated no difference in virologic outcomes for patients randomized to hydroxychloroquine plus standard of care versus standard of care alone, they added. There is also a case series of more than 100 patients with COVID-19 that reportedly improved viral clearance and reduced disease progression, though they said results haven’t been published or presented beyond a news briefing in China.

Randomized, controlled trials of chloroquine and hydroxychloroquine for COVID-19 treatment are underway, and studies are planned or enrolling to look at chloroquine prophylaxis in health care personnel and hydroxychloroquine for postexposure prophylaxis, authors said.

In results from one of those randomized trials, just reported, a higher dose of chloroquine was associated with a cardiac adverse event and an increased mortality risk, leading to the closure of that study arm. In the parallel, double-blinded, phase IIb clinical trial, patients in Brazil with SARS-CoV-2 infection received low or high doses of chloroquine plus ceftriaxone and azithromycin. According to the preprint publication, a higher rate of heart rate–corrected QT interval (QTc) prolongation and a “trend toward higher lethality” was observed in the high-dose group, leading investigators to “strongly recommend” the higher dose be abandoned.

“No apparent benefit of chloroquine was seen regarding lethality in our patients so far, but we will still enroll patients in the low chloroquine dose group to complete the originally planned sample size,” said investigators of the study, which at the time of the report had enrolled 81 out of an anticipated 440 patients.
 

Other COVID-19 pharmacologic therapies under study

Treatments of note in the review included the following:

• Tocilizumab. This monoclonal antibody IL-6 receptor antagonist, approved by the FDA for treatment of rheumatoid arthritis and for cytokine release syndrome related to chimeric antigen receptor (CAR) T-cell therapy, has yielded success in small series of patients with severe cases of COVID-19, according to authors. In one 21-patient report, 91% had clinical improvement, usually after a single dose. In China, tocilizumab is included in COVID-19 treatment guidelines, and several randomized clinical trials are underway in China including patients with COVID-19 with severe pneumonia.
• Immunoglobulin therapy. Antibodies from recovered COVID-19 patients could help with free virus and infected cell immune clearance, the authors said, adding that further studies are warranted beyond a few small published case series that suggest promise. Furthermore, on March 24 the FDA released guidance for screening donors for COVID-19 convalescent plasma and on emergency investigational new drug applications based on this modality.

• Lopinavir/ritonavir. Despite demonstrated in vitro activity against other novel coronaviruses, there is no published in vitro data for lopinavir/ritonavir in SARS-CoV-2, and likely a “limited role” for this combination anticipated in treating COVID-19, according to the review authors. In an open-label randomized clinical trial published in the New England Journal of Medicine (2020 Mar 18. doi: 10.1056/NEJMoa2001282), there were no differences in clinical improvement, viral clearance, or mortality for antiviral treatment versus standard care. Delayed treatment initiation may explain the ineffectiveness, though a subgroup analysis didn’t show a shorter time to clinical improvement for those who got the treatment earlier.

• Ribavirin. Likewise, this antiviral medication has efficacy and safety data suggesting “limited value” for treatment of COVID-19. Treatment of SARS yielded “inconclusive results” for ribavirin, which was also associated with substantial toxicity that included hemolytic anemia in 60% of SARS patients.
• Oseltamivir. While it may treat influenza, it has no documented activity against SARS-CoV-2 in vitro: “This agent has no role in the management of COVID-19 once influenza has been excluded,” said Dr. Sanders and coauthors.
• Corticosteroids. They could decrease inflammatory responses in the lung, but they could also lead to delays in viral clearance and increases in secondary infection risk. Guidelines for COVID-19 say to avoid corticosteroids, and the authors of the review concur, saying that potential harms and lack of proven benefit mean they usually should not be used outside of a randomized clinical trial setting.
• Vaccines. Clearly, vaccines represent the “most effective long-term strategy” to prevent future COVID-19 outbreaks, though at least 12-18 months would be required until vaccines can be widely deployed, authors said.

Dr. Sanders reported no potential conflicts. Senior author James B. Cutrell, MD, also of the University of Texas Southwestern Medical Center, reported nonfinancial support from Gilead and Regeneron outside of the study. No other authors reported disclosures.