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In the face of the US COVID-19 pandemic, the US Substance Abuse and Mental Health Services Administration (SAMHSA) has announced policy changes to allow some patients in opioid treatment programs (OTP) to take home their medication.

According to the agency, states may request “blanket exceptions” for all stable patients in an OTP to receive a 28-day supply of take-home doses of medications such as methadone and buprenorphine, which are used to treat opioid use disorder (OUD).

States may request up to 14 days of take-home medication for patients who are less stable but who can, in the judgment of OTP clinicians, safely handle this level of take-home medication.

“SAMHSA recognizes the evolving issues surrounding COVID-19 and the emerging needs OTPs continue to face,” the agency writes in its updated guidance.

“SAMHSA affirms its commitment to supporting OTPs in any way possible during this time. As such, we are expanding our previous guidance to provide increased flexibility,” the agency said.
 

A ‘Lifesaving’ Decision

Commenting on the SAMHSA policy change, Richard Saitz, MD, professor and chair of the department of community health sciences, Boston University School of Public Health, said, the policy “is not only a good idea, it is critical and lifesaving.”

“This approach had to be done now. With the reduction in face-to-face visits, patients with opioid use disorder need a way to access treatment. If they cannot get opioid agonists, they would withdraw and return to illicit opioid use and high overdose risk and it would be cruel,” said Saitz.

“It is possible that there will be some diversion and some risk of overdose or misuse, but even for less stable patients the benefit likely far outweighs the risk,” he told Medscape Medical News.

Saitz believes policy changes like this should have been made before a crisis.

“Honestly, this is perhaps a silver lining of the crisis” and could lead to permanent change in how OUD is treated in the US, he said.

“Just like we are learning what can be done without a medical in-person visit, we will learn that it is perfectly fine to treat patients with addiction more like we treat patients with other chronic diseases who take medication that has risks and benefits,” Saitz said.

Earlier this week, the Drug Enforcement Administration also announced relaxed dispensing restrictions for registered narcotic treatment programs in cases when a patient is quarantined because of coronavirus.

Typically, only licensed practitioners can dispense or administer OUD medications to patients, but during the COVID-19 crisis, treatment program staff members, law enforcement officers, and national guard personnel will be allowed to deliver OUD medications to an approved “lockbox” at the patient’s doorstep. The change applies only while the coronavirus public health emergency lasts.

“This is also an excellent idea,” Saitz said.
 

ASAM Also Responds

In addition, the American Society of Addiction Medicine (ASAM) released a focused update to its National Practice Guideline for the Treatment of Opioid Use Disorder (NPG).

The update is “especially critical in the context of the ongoing COVID-19 emergency, which threatens to curtail patient access to evidence-based treatment,” the organization said in a news release. The new document updates the 2015 NPG. It includes 13 new recommendations and major revisions to 35 existing recommendations.

One new recommendation states that comprehensive assessment of a patient is critical for treatment planning, but completing all assessments should not delay or preclude initiating pharmacotherapy for OUD. Another new recommendation states that there is no recommended time limit for pharmacotherapy.

ASAM continues to recommend that patients’ psychosocial needs be assessed and psychosocial treatment offered. However, if patients can’t access psychosocial treatment because they are in isolation or have other risk factors that preclude external interactions, clinicians should not delay initiation of medication for the treatment of addiction.

Expanding the use of telemedicine might also be appropriate for many patients, ASAM announced.

They note that the NPG is the first to address in a single document all medications currently approved by the US Food and Drug Administration to treat OUD and opioid withdrawal, including all available buprenorphine formulations.

“All of the updated recommendations are designed to both improve the quality and consistency of care and reduce barriers to access to care for Americans living with OUD. The updated recommendations aim to support initiation of buprenorphine treatment in the emergency department and other urgent care settings,” the society said in the release.

“In addition, [the recommendations] provide greater flexibility on dosing during the initiation of buprenorphine treatment and for initiation of buprenorphine at home (which is also an important change in the midst of the COVID-19 crisis).”

The full document is available online.
 

This article first appeared on Medscape.com.

In the face of the US COVID-19 pandemic, the US Substance Abuse and Mental Health Services Administration (SAMHSA) has announced policy changes to allow some patients in opioid treatment programs (OTP) to take home their medication.

According to the agency, states may request “blanket exceptions” for all stable patients in an OTP to receive a 28-day supply of take-home doses of medications such as methadone and buprenorphine, which are used to treat opioid use disorder (OUD).

States may request up to 14 days of take-home medication for patients who are less stable but who can, in the judgment of OTP clinicians, safely handle this level of take-home medication.

“SAMHSA recognizes the evolving issues surrounding COVID-19 and the emerging needs OTPs continue to face,” the agency writes in its updated guidance.

“SAMHSA affirms its commitment to supporting OTPs in any way possible during this time. As such, we are expanding our previous guidance to provide increased flexibility,” the agency said.
 

A ‘Lifesaving’ Decision

Commenting on the SAMHSA policy change, Richard Saitz, MD, professor and chair of the department of community health sciences, Boston University School of Public Health, said, the policy “is not only a good idea, it is critical and lifesaving.”

“This approach had to be done now. With the reduction in face-to-face visits, patients with opioid use disorder need a way to access treatment. If they cannot get opioid agonists, they would withdraw and return to illicit opioid use and high overdose risk and it would be cruel,” said Saitz.

“It is possible that there will be some diversion and some risk of overdose or misuse, but even for less stable patients the benefit likely far outweighs the risk,” he told Medscape Medical News.

Saitz believes policy changes like this should have been made before a crisis.

“Honestly, this is perhaps a silver lining of the crisis” and could lead to permanent change in how OUD is treated in the US, he said.

“Just like we are learning what can be done without a medical in-person visit, we will learn that it is perfectly fine to treat patients with addiction more like we treat patients with other chronic diseases who take medication that has risks and benefits,” Saitz said.

Earlier this week, the Drug Enforcement Administration also announced relaxed dispensing restrictions for registered narcotic treatment programs in cases when a patient is quarantined because of coronavirus.

Typically, only licensed practitioners can dispense or administer OUD medications to patients, but during the COVID-19 crisis, treatment program staff members, law enforcement officers, and national guard personnel will be allowed to deliver OUD medications to an approved “lockbox” at the patient’s doorstep. The change applies only while the coronavirus public health emergency lasts.

“This is also an excellent idea,” Saitz said.
 

ASAM Also Responds

In addition, the American Society of Addiction Medicine (ASAM) released a focused update to its National Practice Guideline for the Treatment of Opioid Use Disorder (NPG).

The update is “especially critical in the context of the ongoing COVID-19 emergency, which threatens to curtail patient access to evidence-based treatment,” the organization said in a news release. The new document updates the 2015 NPG. It includes 13 new recommendations and major revisions to 35 existing recommendations.

One new recommendation states that comprehensive assessment of a patient is critical for treatment planning, but completing all assessments should not delay or preclude initiating pharmacotherapy for OUD. Another new recommendation states that there is no recommended time limit for pharmacotherapy.

ASAM continues to recommend that patients’ psychosocial needs be assessed and psychosocial treatment offered. However, if patients can’t access psychosocial treatment because they are in isolation or have other risk factors that preclude external interactions, clinicians should not delay initiation of medication for the treatment of addiction.

Expanding the use of telemedicine might also be appropriate for many patients, ASAM announced.

They note that the NPG is the first to address in a single document all medications currently approved by the US Food and Drug Administration to treat OUD and opioid withdrawal, including all available buprenorphine formulations.

“All of the updated recommendations are designed to both improve the quality and consistency of care and reduce barriers to access to care for Americans living with OUD. The updated recommendations aim to support initiation of buprenorphine treatment in the emergency department and other urgent care settings,” the society said in the release.

“In addition, [the recommendations] provide greater flexibility on dosing during the initiation of buprenorphine treatment and for initiation of buprenorphine at home (which is also an important change in the midst of the COVID-19 crisis).”

The full document is available online.
 

This article first appeared on Medscape.com.

In the face of the US COVID-19 pandemic, the US Substance Abuse and Mental Health Services Administration (SAMHSA) has announced policy changes to allow some patients in opioid treatment programs (OTP) to take home their medication.

According to the agency, states may request “blanket exceptions” for all stable patients in an OTP to receive a 28-day supply of take-home doses of medications such as methadone and buprenorphine, which are used to treat opioid use disorder (OUD).

States may request up to 14 days of take-home medication for patients who are less stable but who can, in the judgment of OTP clinicians, safely handle this level of take-home medication.

“SAMHSA recognizes the evolving issues surrounding COVID-19 and the emerging needs OTPs continue to face,” the agency writes in its updated guidance.

“SAMHSA affirms its commitment to supporting OTPs in any way possible during this time. As such, we are expanding our previous guidance to provide increased flexibility,” the agency said.
 

A ‘Lifesaving’ Decision

Commenting on the SAMHSA policy change, Richard Saitz, MD, professor and chair of the department of community health sciences, Boston University School of Public Health, said, the policy “is not only a good idea, it is critical and lifesaving.”

“This approach had to be done now. With the reduction in face-to-face visits, patients with opioid use disorder need a way to access treatment. If they cannot get opioid agonists, they would withdraw and return to illicit opioid use and high overdose risk and it would be cruel,” said Saitz.

“It is possible that there will be some diversion and some risk of overdose or misuse, but even for less stable patients the benefit likely far outweighs the risk,” he told Medscape Medical News.

Saitz believes policy changes like this should have been made before a crisis.

“Honestly, this is perhaps a silver lining of the crisis” and could lead to permanent change in how OUD is treated in the US, he said.

“Just like we are learning what can be done without a medical in-person visit, we will learn that it is perfectly fine to treat patients with addiction more like we treat patients with other chronic diseases who take medication that has risks and benefits,” Saitz said.

Earlier this week, the Drug Enforcement Administration also announced relaxed dispensing restrictions for registered narcotic treatment programs in cases when a patient is quarantined because of coronavirus.

Typically, only licensed practitioners can dispense or administer OUD medications to patients, but during the COVID-19 crisis, treatment program staff members, law enforcement officers, and national guard personnel will be allowed to deliver OUD medications to an approved “lockbox” at the patient’s doorstep. The change applies only while the coronavirus public health emergency lasts.

“This is also an excellent idea,” Saitz said.
 

ASAM Also Responds

In addition, the American Society of Addiction Medicine (ASAM) released a focused update to its National Practice Guideline for the Treatment of Opioid Use Disorder (NPG).

The update is “especially critical in the context of the ongoing COVID-19 emergency, which threatens to curtail patient access to evidence-based treatment,” the organization said in a news release. The new document updates the 2015 NPG. It includes 13 new recommendations and major revisions to 35 existing recommendations.

One new recommendation states that comprehensive assessment of a patient is critical for treatment planning, but completing all assessments should not delay or preclude initiating pharmacotherapy for OUD. Another new recommendation states that there is no recommended time limit for pharmacotherapy.

ASAM continues to recommend that patients’ psychosocial needs be assessed and psychosocial treatment offered. However, if patients can’t access psychosocial treatment because they are in isolation or have other risk factors that preclude external interactions, clinicians should not delay initiation of medication for the treatment of addiction.

Expanding the use of telemedicine might also be appropriate for many patients, ASAM announced.

They note that the NPG is the first to address in a single document all medications currently approved by the US Food and Drug Administration to treat OUD and opioid withdrawal, including all available buprenorphine formulations.

“All of the updated recommendations are designed to both improve the quality and consistency of care and reduce barriers to access to care for Americans living with OUD. The updated recommendations aim to support initiation of buprenorphine treatment in the emergency department and other urgent care settings,” the society said in the release.

“In addition, [the recommendations] provide greater flexibility on dosing during the initiation of buprenorphine treatment and for initiation of buprenorphine at home (which is also an important change in the midst of the COVID-19 crisis).”

The full document is available online.
 

This article first appeared on Medscape.com.

Cystic fibrosis transmembrane conductance regulator modulators are bringing new hope to many patients with CF. But what do physicians and patients need to know about the latest CFTR modulator therapies?

Susan M. Millard, MD, is a pediatric pulmonologist at Helen DeVos Children's Hospital in Grand Rapids, Mich. In an audio interview, Dr. Millard discusses the new Food and Drug Administration-approved combination therapy of elexacaftor, tezacaftor, and ivacaftor (Trikafta). It's a trio that could make a significant difference for the roughly 90% of patients with at least one F508del mutation.

Dr. Millard outlines which patients are candidates for the combination therapy,  what physicians and patients can expect with Trikafta use, and how the drug affects patients' use of other CF therapies. She also explains the steps physicians should take before starting patients on the therapy, and what side effects to watch for during treatment.

Dr. Millard is the local principal investigator for CF research at Helen DeVos Children’s Hospital, including Mylan, Therapeutic Development Network, and Vertex clinical studies.

Cystic fibrosis transmembrane conductance regulator modulators are bringing new hope to many patients with CF. But what do physicians and patients need to know about the latest CFTR modulator therapies?

Susan M. Millard, MD, is a pediatric pulmonologist at Helen DeVos Children's Hospital in Grand Rapids, Mich. In an audio interview, Dr. Millard discusses the new Food and Drug Administration-approved combination therapy of elexacaftor, tezacaftor, and ivacaftor (Trikafta). It's a trio that could make a significant difference for the roughly 90% of patients with at least one F508del mutation.

Dr. Millard outlines which patients are candidates for the combination therapy,  what physicians and patients can expect with Trikafta use, and how the drug affects patients' use of other CF therapies. She also explains the steps physicians should take before starting patients on the therapy, and what side effects to watch for during treatment.

Dr. Millard is the local principal investigator for CF research at Helen DeVos Children’s Hospital, including Mylan, Therapeutic Development Network, and Vertex clinical studies.

Cystic fibrosis transmembrane conductance regulator modulators are bringing new hope to many patients with CF. But what do physicians and patients need to know about the latest CFTR modulator therapies?

Susan M. Millard, MD, is a pediatric pulmonologist at Helen DeVos Children's Hospital in Grand Rapids, Mich. In an audio interview, Dr. Millard discusses the new Food and Drug Administration-approved combination therapy of elexacaftor, tezacaftor, and ivacaftor (Trikafta). It's a trio that could make a significant difference for the roughly 90% of patients with at least one F508del mutation.

Dr. Millard outlines which patients are candidates for the combination therapy,  what physicians and patients can expect with Trikafta use, and how the drug affects patients' use of other CF therapies. She also explains the steps physicians should take before starting patients on the therapy, and what side effects to watch for during treatment.

Dr. Millard is the local principal investigator for CF research at Helen DeVos Children’s Hospital, including Mylan, Therapeutic Development Network, and Vertex clinical studies.

Therapeutics could be available in the near term to help treat COVID-19 patients, according to President Donald Trump.

Courtesy CDC

During a March 19 press briefing, the president highlighted two drugs that could be put into play in the battle against the virus.

The first product is hydroxychloroquine (Plaquenil), a drug used to treat malaria and severe arthritis, is showing promise as a possible treatment for COVID-19.

“The nice part is it’s been around for a long time, so we know that if things go as planned, it’s not going to kill anybody,” President Trump said. “When you go with a brand-new drug, you don’t know that that’s going to happen,” adding that it has shown “very, very encouraging” results as a potential treatment for COVID-19.

He said this drug will be made available “almost immediately.” During the press conference, Food and Drug Administration Commissioner Stephen M. Hahn, MD, suggested the drug would be made available in the context of a large pragmatic clinical trial, enabling the FDA to collect data on it and make a long-term decision on its viability to treat COVID-19.

Dr. Hahn also pointed to the Gilead drug remdesivir – a drug originally developed to fight Ebola and currently undergoing clinical trials – as another possible candidate for a near-term therapeutic to help treat patients while vaccine development occurs.

Dr. Hahn noted that, while the agency is striving to provide regulatory flexibility, safety is paramount. “Let me make one thing clear: FDA’s responsibility to the American people is to ensure that products are safe and effective and that we are continuing to do that.”

He noted that if these and other experimental drugs show promise, physicians can request them under “compassionate use” provisions.

“We have criteria for that, and very speedy approval for that,” Dr. Hahn said. “The important thing about compassionate use ... this is even beyond ‘right to try.’ [We] get to collect the information about that.”

He noted that the FDA is looking at other drugs that are approved for other indications. The examinations of existing therapies are meant to be a bridge as companies work to develop new therapeutics as well as vaccines.

Dr. Hahn also highlighted a cross-agency effort on convalescent plasma, which uses the plasma from a patient who has recovered from COVID-19 infection to help patients fight the virus. “This is a possible treatment; this is not a proven treatment, “ Dr. Hahn said.

Takeda is working on an immunoglobulin treatment based on its intravenous immunoglobulin product Gammagard Liquid.

Julie Kim, president of plasma-derived therapies at Takeda, said the company should be able to go straight into testing efficacy of this approach, given the known safety profile of the treatment. She made the comments during a March 18 press briefing hosted by Pharmaceutical Research and Manufacturers of America (PhRMA). Ms. Kim did caution that this would not be a mass market kind of treatment, as supply would depend on plasma donations from individuals who have fully recovered from a COVID-19 infection. She estimated that the treatment could be available to a targeted group of high-risk patients in 9-18 months.

PhRMA president and CEO Stephen Ubl said the industry is “literally working around the clock” on four key areas: development of new diagnostics, identification of potential existing treatments to make available through trials and compassionate use, development of novel therapies, and development of a vaccine.

There are more than 80 clinical trials underway on existing treatments that could have approval to treat COVID-19 in a matter of months, he said.

Mikael Dolsten, MD, PhD, chief scientific officer at Pfizer, said that the company is working with Germany-based BioNTech SE to develop an mRNA-based vaccine for COVID-19, with testing expected to begin in Germany, China, and the United States by the end of April. The company also is screening antiviral compounds that were previously in development against other coronavirus diseases.

Clement Lewin, PhD, associate vice president of R&D strategy for vaccines at Sanofi, said the company has partnered with Regeneron to launch a trial of sarilumab (Kevzara), a drug approved to treat moderate to severe rheumatoid arthritis, to help treat COVID-19.

Meanwhile, Lilly Chief Scientific Officer Daniel Skovronsky, MD, PhD, noted that his company is collaborating with AbCellera to develop therapeutics using monoclonal antibodies isolated from one of the first U.S. patients who recovered from COVID-19. He said the goal is to begin testing within the next 4 months.

Separately, World Health Organization Director General Tedros Adhanom Ghebreyesus announced during a March 18 press conference that it is spearheading a large international study examining a number of different treatments in what has been dubbed the SOLIDARITY trial. Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland, and Thailand have signed on to be a part of the trial, with more countries expected to participate.

“I continue to be inspired by the many demonstrations of solidarity from all over the world,” he said. “These and other efforts give me hope that together, we can and will prevail. This virus is presenting us with an unprecedented threat. But it’s also an unprecedented opportunity to come together as one against a common enemy, an enemy against humanity.”

[email protected]

Therapeutics could be available in the near term to help treat COVID-19 patients, according to President Donald Trump.

Courtesy CDC

During a March 19 press briefing, the president highlighted two drugs that could be put into play in the battle against the virus.

The first product is hydroxychloroquine (Plaquenil), a drug used to treat malaria and severe arthritis, is showing promise as a possible treatment for COVID-19.

“The nice part is it’s been around for a long time, so we know that if things go as planned, it’s not going to kill anybody,” President Trump said. “When you go with a brand-new drug, you don’t know that that’s going to happen,” adding that it has shown “very, very encouraging” results as a potential treatment for COVID-19.

He said this drug will be made available “almost immediately.” During the press conference, Food and Drug Administration Commissioner Stephen M. Hahn, MD, suggested the drug would be made available in the context of a large pragmatic clinical trial, enabling the FDA to collect data on it and make a long-term decision on its viability to treat COVID-19.

Dr. Hahn also pointed to the Gilead drug remdesivir – a drug originally developed to fight Ebola and currently undergoing clinical trials – as another possible candidate for a near-term therapeutic to help treat patients while vaccine development occurs.

Dr. Hahn noted that, while the agency is striving to provide regulatory flexibility, safety is paramount. “Let me make one thing clear: FDA’s responsibility to the American people is to ensure that products are safe and effective and that we are continuing to do that.”

He noted that if these and other experimental drugs show promise, physicians can request them under “compassionate use” provisions.

“We have criteria for that, and very speedy approval for that,” Dr. Hahn said. “The important thing about compassionate use ... this is even beyond ‘right to try.’ [We] get to collect the information about that.”

He noted that the FDA is looking at other drugs that are approved for other indications. The examinations of existing therapies are meant to be a bridge as companies work to develop new therapeutics as well as vaccines.

Dr. Hahn also highlighted a cross-agency effort on convalescent plasma, which uses the plasma from a patient who has recovered from COVID-19 infection to help patients fight the virus. “This is a possible treatment; this is not a proven treatment, “ Dr. Hahn said.

Takeda is working on an immunoglobulin treatment based on its intravenous immunoglobulin product Gammagard Liquid.

Julie Kim, president of plasma-derived therapies at Takeda, said the company should be able to go straight into testing efficacy of this approach, given the known safety profile of the treatment. She made the comments during a March 18 press briefing hosted by Pharmaceutical Research and Manufacturers of America (PhRMA). Ms. Kim did caution that this would not be a mass market kind of treatment, as supply would depend on plasma donations from individuals who have fully recovered from a COVID-19 infection. She estimated that the treatment could be available to a targeted group of high-risk patients in 9-18 months.

PhRMA president and CEO Stephen Ubl said the industry is “literally working around the clock” on four key areas: development of new diagnostics, identification of potential existing treatments to make available through trials and compassionate use, development of novel therapies, and development of a vaccine.

There are more than 80 clinical trials underway on existing treatments that could have approval to treat COVID-19 in a matter of months, he said.

Mikael Dolsten, MD, PhD, chief scientific officer at Pfizer, said that the company is working with Germany-based BioNTech SE to develop an mRNA-based vaccine for COVID-19, with testing expected to begin in Germany, China, and the United States by the end of April. The company also is screening antiviral compounds that were previously in development against other coronavirus diseases.

Clement Lewin, PhD, associate vice president of R&D strategy for vaccines at Sanofi, said the company has partnered with Regeneron to launch a trial of sarilumab (Kevzara), a drug approved to treat moderate to severe rheumatoid arthritis, to help treat COVID-19.

Meanwhile, Lilly Chief Scientific Officer Daniel Skovronsky, MD, PhD, noted that his company is collaborating with AbCellera to develop therapeutics using monoclonal antibodies isolated from one of the first U.S. patients who recovered from COVID-19. He said the goal is to begin testing within the next 4 months.

Separately, World Health Organization Director General Tedros Adhanom Ghebreyesus announced during a March 18 press conference that it is spearheading a large international study examining a number of different treatments in what has been dubbed the SOLIDARITY trial. Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland, and Thailand have signed on to be a part of the trial, with more countries expected to participate.

“I continue to be inspired by the many demonstrations of solidarity from all over the world,” he said. “These and other efforts give me hope that together, we can and will prevail. This virus is presenting us with an unprecedented threat. But it’s also an unprecedented opportunity to come together as one against a common enemy, an enemy against humanity.”

[email protected]

Therapeutics could be available in the near term to help treat COVID-19 patients, according to President Donald Trump.

Courtesy CDC

During a March 19 press briefing, the president highlighted two drugs that could be put into play in the battle against the virus.

The first product is hydroxychloroquine (Plaquenil), a drug used to treat malaria and severe arthritis, is showing promise as a possible treatment for COVID-19.

“The nice part is it’s been around for a long time, so we know that if things go as planned, it’s not going to kill anybody,” President Trump said. “When you go with a brand-new drug, you don’t know that that’s going to happen,” adding that it has shown “very, very encouraging” results as a potential treatment for COVID-19.

He said this drug will be made available “almost immediately.” During the press conference, Food and Drug Administration Commissioner Stephen M. Hahn, MD, suggested the drug would be made available in the context of a large pragmatic clinical trial, enabling the FDA to collect data on it and make a long-term decision on its viability to treat COVID-19.

Dr. Hahn also pointed to the Gilead drug remdesivir – a drug originally developed to fight Ebola and currently undergoing clinical trials – as another possible candidate for a near-term therapeutic to help treat patients while vaccine development occurs.

Dr. Hahn noted that, while the agency is striving to provide regulatory flexibility, safety is paramount. “Let me make one thing clear: FDA’s responsibility to the American people is to ensure that products are safe and effective and that we are continuing to do that.”

He noted that if these and other experimental drugs show promise, physicians can request them under “compassionate use” provisions.

“We have criteria for that, and very speedy approval for that,” Dr. Hahn said. “The important thing about compassionate use ... this is even beyond ‘right to try.’ [We] get to collect the information about that.”

He noted that the FDA is looking at other drugs that are approved for other indications. The examinations of existing therapies are meant to be a bridge as companies work to develop new therapeutics as well as vaccines.

Dr. Hahn also highlighted a cross-agency effort on convalescent plasma, which uses the plasma from a patient who has recovered from COVID-19 infection to help patients fight the virus. “This is a possible treatment; this is not a proven treatment, “ Dr. Hahn said.

Takeda is working on an immunoglobulin treatment based on its intravenous immunoglobulin product Gammagard Liquid.

Julie Kim, president of plasma-derived therapies at Takeda, said the company should be able to go straight into testing efficacy of this approach, given the known safety profile of the treatment. She made the comments during a March 18 press briefing hosted by Pharmaceutical Research and Manufacturers of America (PhRMA). Ms. Kim did caution that this would not be a mass market kind of treatment, as supply would depend on plasma donations from individuals who have fully recovered from a COVID-19 infection. She estimated that the treatment could be available to a targeted group of high-risk patients in 9-18 months.

PhRMA president and CEO Stephen Ubl said the industry is “literally working around the clock” on four key areas: development of new diagnostics, identification of potential existing treatments to make available through trials and compassionate use, development of novel therapies, and development of a vaccine.

There are more than 80 clinical trials underway on existing treatments that could have approval to treat COVID-19 in a matter of months, he said.

Mikael Dolsten, MD, PhD, chief scientific officer at Pfizer, said that the company is working with Germany-based BioNTech SE to develop an mRNA-based vaccine for COVID-19, with testing expected to begin in Germany, China, and the United States by the end of April. The company also is screening antiviral compounds that were previously in development against other coronavirus diseases.

Clement Lewin, PhD, associate vice president of R&D strategy for vaccines at Sanofi, said the company has partnered with Regeneron to launch a trial of sarilumab (Kevzara), a drug approved to treat moderate to severe rheumatoid arthritis, to help treat COVID-19.

Meanwhile, Lilly Chief Scientific Officer Daniel Skovronsky, MD, PhD, noted that his company is collaborating with AbCellera to develop therapeutics using monoclonal antibodies isolated from one of the first U.S. patients who recovered from COVID-19. He said the goal is to begin testing within the next 4 months.

Separately, World Health Organization Director General Tedros Adhanom Ghebreyesus announced during a March 18 press conference that it is spearheading a large international study examining a number of different treatments in what has been dubbed the SOLIDARITY trial. Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland, and Thailand have signed on to be a part of the trial, with more countries expected to participate.

“I continue to be inspired by the many demonstrations of solidarity from all over the world,” he said. “These and other efforts give me hope that together, we can and will prevail. This virus is presenting us with an unprecedented threat. But it’s also an unprecedented opportunity to come together as one against a common enemy, an enemy against humanity.”

[email protected]

*Correction, 3/20/2020: An earlier version of this story misstated the age range for COVID-19 deaths. The headline of this story was corrected to read "20%  of COVID-19 deaths were aged 20-64 years" and the text was adjusted to reflect the correct age range.

A review of more than 4,000 U.S. patients who were diagnosed with novel coronavirus infection (COVID-19) shows that an unexpected 20% of deaths occurred among adults aged 20-64 years, and 20% of those hospitalized were aged 20-44 years. 

Courtesy NIAID-RML

The expectation has been that people over 65 are most vulnerable to COVID-19 infection, but this study indicates that, at least in the United States, a significant number of patients under 45 can land in the hospital and can even die of the disease. 

To assess rates of hospitalization, admission to an ICU, and death among patients with COVID-19 by age group, the Centers for Disease Control and Prevention analyzed 4,226 COVID-19 cases in the United States that were reported between Feb. 12 and March 16.

Overall, older patients in this group were the most likely to be hospitalized, to be admitted to ICU, and to die of COVID-19. A total of 31% of the cases, 45% of hospitalizations, 53% of ICU admissions, and 80% of deaths occurred in patients aged 65 years and older. “Similar to reports from other countries, this finding suggests that the risk for serious disease and death from COVID-19 is higher in older age groups,” said the investigators. “In contrast, persons aged [19 years and younger] appear to have milder COVID-19 illness, with almost no hospitalizations or deaths reported to date in the United States in this age group.”

But compared with the under-19 group, patients aged 20-44 years appeared to be at higher risk for hospitalization and ICU admission, according to the data published March 18 in Morbidity and Mortality Weekly Report. 

The researchers excluded from their analysis patients who repatriated to the United States from Wuhan, China, and from Japan, including patients repatriated from cruise ships. Data on serious underlying health conditions were not available, and many cases were missing key data, they noted.
Among 508 patients known to have been hospitalized, 9% were aged 85 years or older, 36% were aged 65-84 years, 17% were aged 55-64 years, 18% were 45-54 years, and 20% were aged 20-44 years.

Among 121 patients admitted to an ICU, 7% were aged 85 years or older, 46% were aged 65-84 years, 36% were aged 45-64 years, and 12% were aged 20-44 years. Between 11% and 31% of patients with COVID-19 aged 75-84 years were admitted to an ICU.

Of 44 deaths, more than a third occurred among adults aged 85 years and older, and 46% occurred among adults aged 65-84 years, and 20% occurred among adults aged 20-64 years.

More follow-up time is needed to determine outcomes among active cases, the researchers said. These results also might overestimate the prevalence of severe disease because the initial approach to testing for COVID-19 focused on people with more severe disease. “These preliminary data also demonstrate that severe illness leading to hospitalization, including ICU admission and death, can occur in adults of any age with COVID-19,” according to the CDC.

[email protected]

SOURCE: CDC COVID-19 Response Team. MMWR Morb Mortal Wkly Rep. 2020 Mar 18. doi: 10.15585/mmwr.mm6912e2.

*Correction, 3/20/2020: An earlier version of this story misstated the age range for COVID-19 deaths. The headline of this story was corrected to read "20%  of COVID-19 deaths were aged 20-64 years" and the text was adjusted to reflect the correct age range.

A review of more than 4,000 U.S. patients who were diagnosed with novel coronavirus infection (COVID-19) shows that an unexpected 20% of deaths occurred among adults aged 20-64 years, and 20% of those hospitalized were aged 20-44 years. 

Courtesy NIAID-RML

The expectation has been that people over 65 are most vulnerable to COVID-19 infection, but this study indicates that, at least in the United States, a significant number of patients under 45 can land in the hospital and can even die of the disease. 

To assess rates of hospitalization, admission to an ICU, and death among patients with COVID-19 by age group, the Centers for Disease Control and Prevention analyzed 4,226 COVID-19 cases in the United States that were reported between Feb. 12 and March 16.

Overall, older patients in this group were the most likely to be hospitalized, to be admitted to ICU, and to die of COVID-19. A total of 31% of the cases, 45% of hospitalizations, 53% of ICU admissions, and 80% of deaths occurred in patients aged 65 years and older. “Similar to reports from other countries, this finding suggests that the risk for serious disease and death from COVID-19 is higher in older age groups,” said the investigators. “In contrast, persons aged [19 years and younger] appear to have milder COVID-19 illness, with almost no hospitalizations or deaths reported to date in the United States in this age group.”

But compared with the under-19 group, patients aged 20-44 years appeared to be at higher risk for hospitalization and ICU admission, according to the data published March 18 in Morbidity and Mortality Weekly Report. 

The researchers excluded from their analysis patients who repatriated to the United States from Wuhan, China, and from Japan, including patients repatriated from cruise ships. Data on serious underlying health conditions were not available, and many cases were missing key data, they noted.
Among 508 patients known to have been hospitalized, 9% were aged 85 years or older, 36% were aged 65-84 years, 17% were aged 55-64 years, 18% were 45-54 years, and 20% were aged 20-44 years.

Among 121 patients admitted to an ICU, 7% were aged 85 years or older, 46% were aged 65-84 years, 36% were aged 45-64 years, and 12% were aged 20-44 years. Between 11% and 31% of patients with COVID-19 aged 75-84 years were admitted to an ICU.

Of 44 deaths, more than a third occurred among adults aged 85 years and older, and 46% occurred among adults aged 65-84 years, and 20% occurred among adults aged 20-64 years.

More follow-up time is needed to determine outcomes among active cases, the researchers said. These results also might overestimate the prevalence of severe disease because the initial approach to testing for COVID-19 focused on people with more severe disease. “These preliminary data also demonstrate that severe illness leading to hospitalization, including ICU admission and death, can occur in adults of any age with COVID-19,” according to the CDC.

[email protected]

SOURCE: CDC COVID-19 Response Team. MMWR Morb Mortal Wkly Rep. 2020 Mar 18. doi: 10.15585/mmwr.mm6912e2.

*Correction, 3/20/2020: An earlier version of this story misstated the age range for COVID-19 deaths. The headline of this story was corrected to read "20%  of COVID-19 deaths were aged 20-64 years" and the text was adjusted to reflect the correct age range.

A review of more than 4,000 U.S. patients who were diagnosed with novel coronavirus infection (COVID-19) shows that an unexpected 20% of deaths occurred among adults aged 20-64 years, and 20% of those hospitalized were aged 20-44 years. 

Courtesy NIAID-RML

The expectation has been that people over 65 are most vulnerable to COVID-19 infection, but this study indicates that, at least in the United States, a significant number of patients under 45 can land in the hospital and can even die of the disease. 

To assess rates of hospitalization, admission to an ICU, and death among patients with COVID-19 by age group, the Centers for Disease Control and Prevention analyzed 4,226 COVID-19 cases in the United States that were reported between Feb. 12 and March 16.

Overall, older patients in this group were the most likely to be hospitalized, to be admitted to ICU, and to die of COVID-19. A total of 31% of the cases, 45% of hospitalizations, 53% of ICU admissions, and 80% of deaths occurred in patients aged 65 years and older. “Similar to reports from other countries, this finding suggests that the risk for serious disease and death from COVID-19 is higher in older age groups,” said the investigators. “In contrast, persons aged [19 years and younger] appear to have milder COVID-19 illness, with almost no hospitalizations or deaths reported to date in the United States in this age group.”

But compared with the under-19 group, patients aged 20-44 years appeared to be at higher risk for hospitalization and ICU admission, according to the data published March 18 in Morbidity and Mortality Weekly Report. 

The researchers excluded from their analysis patients who repatriated to the United States from Wuhan, China, and from Japan, including patients repatriated from cruise ships. Data on serious underlying health conditions were not available, and many cases were missing key data, they noted.
Among 508 patients known to have been hospitalized, 9% were aged 85 years or older, 36% were aged 65-84 years, 17% were aged 55-64 years, 18% were 45-54 years, and 20% were aged 20-44 years.

Among 121 patients admitted to an ICU, 7% were aged 85 years or older, 46% were aged 65-84 years, 36% were aged 45-64 years, and 12% were aged 20-44 years. Between 11% and 31% of patients with COVID-19 aged 75-84 years were admitted to an ICU.

Of 44 deaths, more than a third occurred among adults aged 85 years and older, and 46% occurred among adults aged 65-84 years, and 20% occurred among adults aged 20-64 years.

More follow-up time is needed to determine outcomes among active cases, the researchers said. These results also might overestimate the prevalence of severe disease because the initial approach to testing for COVID-19 focused on people with more severe disease. “These preliminary data also demonstrate that severe illness leading to hospitalization, including ICU admission and death, can occur in adults of any age with COVID-19,” according to the CDC.

[email protected]

SOURCE: CDC COVID-19 Response Team. MMWR Morb Mortal Wkly Rep. 2020 Mar 18. doi: 10.15585/mmwr.mm6912e2.

Rheumatologists the world over are joining forces to create a COVID-19 rheumatology registry designed to help both patients and providers learn from each other regarding management of rheumatologic diseases and risk of infection among patients who are commonly on chronic immunosuppressive medications.

The COVID-19 Global Rheumatology Alliance, a consortium supported by more than 50 major clinical societies and foundations, quickly grew from messages on social media platforms to a multinational group focused on the common goal of helping to “guide rheumatology clinicians in assessing and treating patients with rheumatologic disease and in evaluating the risk of infection in patients on immunosuppression.”

As of this writing, the rheumatology registry is still being assembled, and organizers are currently seeking approvals from various authorities. As of March 17, 2020, the Institutional Review Board (IRB) at the University of California, San Francisco, has determined that the registry is exempt from IRB approval requirements, a finding that should apply elsewhere in the United States, according to the registry website.

When it is fully up and running, clinicians will be able to report to the secure website on any and all cases of patients with rheumatologic disorders who present with COVID-19 of any severity, including patients with mild disease or asymptomatic patients who test positive.

“We are aiming for 5 to 10 minutes to input the data. We don’t want to drag them away from their clinical duties too much, but if clinicians are able to spare a few minutes to put in details about a patient, then that’s going to help build our knowledge and it’s going to help them with other patients,” said Philip Robinson, MBChB, associate professor of medicine at the University of Queensland in Brisbane, Australia, and the chief architect of the registry.

The data will be deindentified, with no protected health care information required or included, and made available to the global rheumatology community, but the registry will not offer clinical advice, Dr. Robinson said in an interview.

“This is observational data, it’s not randomized, but our approach is that some data is better than no data,” he said.

He also cautioned that the data will need careful interpretation, because information about patients with mild symptoms may offer false reassurances about the severity or extent of infection.

“For example, the patients with severe cases may be in the ICU, and can’t tell their doctors that they’re on methotrexate, so you can see how we need to be really careful about the messages from that data and not misinterpret it,” he said.

The COVID-19 rheumatology registry was inspired by a similar effort in the gastroenterology community, the Surveillance Epidemiology of Coronavirus Under Research Exclusion (SECURE-IBD) registry. Patients with inflammatory bowel disease are often treated with immunosuppressive biologic agents familiar to the rheumatology community, such as infliximab (Remicade and biosimilars) and adalimumab (Humira and biosimilars), and methotrexate.

Rheumatologists the world over are joining forces to create a COVID-19 rheumatology registry designed to help both patients and providers learn from each other regarding management of rheumatologic diseases and risk of infection among patients who are commonly on chronic immunosuppressive medications.

The COVID-19 Global Rheumatology Alliance, a consortium supported by more than 50 major clinical societies and foundations, quickly grew from messages on social media platforms to a multinational group focused on the common goal of helping to “guide rheumatology clinicians in assessing and treating patients with rheumatologic disease and in evaluating the risk of infection in patients on immunosuppression.”

As of this writing, the rheumatology registry is still being assembled, and organizers are currently seeking approvals from various authorities. As of March 17, 2020, the Institutional Review Board (IRB) at the University of California, San Francisco, has determined that the registry is exempt from IRB approval requirements, a finding that should apply elsewhere in the United States, according to the registry website.

When it is fully up and running, clinicians will be able to report to the secure website on any and all cases of patients with rheumatologic disorders who present with COVID-19 of any severity, including patients with mild disease or asymptomatic patients who test positive.

“We are aiming for 5 to 10 minutes to input the data. We don’t want to drag them away from their clinical duties too much, but if clinicians are able to spare a few minutes to put in details about a patient, then that’s going to help build our knowledge and it’s going to help them with other patients,” said Philip Robinson, MBChB, associate professor of medicine at the University of Queensland in Brisbane, Australia, and the chief architect of the registry.

The data will be deindentified, with no protected health care information required or included, and made available to the global rheumatology community, but the registry will not offer clinical advice, Dr. Robinson said in an interview.

“This is observational data, it’s not randomized, but our approach is that some data is better than no data,” he said.

He also cautioned that the data will need careful interpretation, because information about patients with mild symptoms may offer false reassurances about the severity or extent of infection.

“For example, the patients with severe cases may be in the ICU, and can’t tell their doctors that they’re on methotrexate, so you can see how we need to be really careful about the messages from that data and not misinterpret it,” he said.

The COVID-19 rheumatology registry was inspired by a similar effort in the gastroenterology community, the Surveillance Epidemiology of Coronavirus Under Research Exclusion (SECURE-IBD) registry. Patients with inflammatory bowel disease are often treated with immunosuppressive biologic agents familiar to the rheumatology community, such as infliximab (Remicade and biosimilars) and adalimumab (Humira and biosimilars), and methotrexate.

Rheumatologists the world over are joining forces to create a COVID-19 rheumatology registry designed to help both patients and providers learn from each other regarding management of rheumatologic diseases and risk of infection among patients who are commonly on chronic immunosuppressive medications.

The COVID-19 Global Rheumatology Alliance, a consortium supported by more than 50 major clinical societies and foundations, quickly grew from messages on social media platforms to a multinational group focused on the common goal of helping to “guide rheumatology clinicians in assessing and treating patients with rheumatologic disease and in evaluating the risk of infection in patients on immunosuppression.”

As of this writing, the rheumatology registry is still being assembled, and organizers are currently seeking approvals from various authorities. As of March 17, 2020, the Institutional Review Board (IRB) at the University of California, San Francisco, has determined that the registry is exempt from IRB approval requirements, a finding that should apply elsewhere in the United States, according to the registry website.

When it is fully up and running, clinicians will be able to report to the secure website on any and all cases of patients with rheumatologic disorders who present with COVID-19 of any severity, including patients with mild disease or asymptomatic patients who test positive.

“We are aiming for 5 to 10 minutes to input the data. We don’t want to drag them away from their clinical duties too much, but if clinicians are able to spare a few minutes to put in details about a patient, then that’s going to help build our knowledge and it’s going to help them with other patients,” said Philip Robinson, MBChB, associate professor of medicine at the University of Queensland in Brisbane, Australia, and the chief architect of the registry.

The data will be deindentified, with no protected health care information required or included, and made available to the global rheumatology community, but the registry will not offer clinical advice, Dr. Robinson said in an interview.

“This is observational data, it’s not randomized, but our approach is that some data is better than no data,” he said.

He also cautioned that the data will need careful interpretation, because information about patients with mild symptoms may offer false reassurances about the severity or extent of infection.

“For example, the patients with severe cases may be in the ICU, and can’t tell their doctors that they’re on methotrexate, so you can see how we need to be really careful about the messages from that data and not misinterpret it,” he said.

The COVID-19 rheumatology registry was inspired by a similar effort in the gastroenterology community, the Surveillance Epidemiology of Coronavirus Under Research Exclusion (SECURE-IBD) registry. Patients with inflammatory bowel disease are often treated with immunosuppressive biologic agents familiar to the rheumatology community, such as infliximab (Remicade and biosimilars) and adalimumab (Humira and biosimilars), and methotrexate.

As of this morning, March 19, 2020, I’m still working.

Granted, there aren’t a lot of people who want to come in. My schedule has dropped to 3-5 follow-ups per day and no new patients.

I can understand people not wanting to expose themselves unnecessarily right now.

But, I’m still a doctor. What drove me to study for the MCAT, apply to med school 2 years in a row, and then survive medical school, internship, residency, and fellowship ... is still there.

Like I said in my 1987 personal statement, I still want to help people. I’d feel remiss if (provided I don’t have COVID-19) I didn’t show up for work each day, ready to care for any who need me. It’s part of who I am, what I do, and what I believe in.

I’m sure my colleagues in family practice, internal medicine, and pulmonology are swamped right now, but neurologists with primarily outpatient practices are taking a back seat except for a handful of patients.

My small office has been set up for my staff to work remotely in a pinch since 2016, so that was easy to enact. The three of us cover the phones the way we always have, and I see patients here.

With the relaxing of telehealth requirements for Medicare that were announced on March 17, I’m setting up to “see” patients remotely.

The whole situation seems bizarre and surreal.

It’s easy for anyone to read too much into anything. A brief tickle in my throat when I wake up, or a sneeze, or a few coughs, suddenly trigger a flurry of “could I have it?” thoughts. Fortunately, they fade when things quickly return to normal, but a few weeks ago I wouldn’t have thought anything of them at all.

Inevitably, I and pretty much everyone else will be exposed to or catch the virus. It’s what virions do. Unless you absolutely isolate yourself on a desert island, it will happen. When it does, you can only hope for the best.

I’m here for my patients today and will be as long as they need me. Unless I have to go into quarantine, of course. And even then, if able, I’ll do the best I can to treat them remotely.

That’s all I could ever want.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

As of this morning, March 19, 2020, I’m still working.

Granted, there aren’t a lot of people who want to come in. My schedule has dropped to 3-5 follow-ups per day and no new patients.

I can understand people not wanting to expose themselves unnecessarily right now.

But, I’m still a doctor. What drove me to study for the MCAT, apply to med school 2 years in a row, and then survive medical school, internship, residency, and fellowship ... is still there.

Like I said in my 1987 personal statement, I still want to help people. I’d feel remiss if (provided I don’t have COVID-19) I didn’t show up for work each day, ready to care for any who need me. It’s part of who I am, what I do, and what I believe in.

I’m sure my colleagues in family practice, internal medicine, and pulmonology are swamped right now, but neurologists with primarily outpatient practices are taking a back seat except for a handful of patients.

My small office has been set up for my staff to work remotely in a pinch since 2016, so that was easy to enact. The three of us cover the phones the way we always have, and I see patients here.

With the relaxing of telehealth requirements for Medicare that were announced on March 17, I’m setting up to “see” patients remotely.

The whole situation seems bizarre and surreal.

It’s easy for anyone to read too much into anything. A brief tickle in my throat when I wake up, or a sneeze, or a few coughs, suddenly trigger a flurry of “could I have it?” thoughts. Fortunately, they fade when things quickly return to normal, but a few weeks ago I wouldn’t have thought anything of them at all.

Inevitably, I and pretty much everyone else will be exposed to or catch the virus. It’s what virions do. Unless you absolutely isolate yourself on a desert island, it will happen. When it does, you can only hope for the best.

I’m here for my patients today and will be as long as they need me. Unless I have to go into quarantine, of course. And even then, if able, I’ll do the best I can to treat them remotely.

That’s all I could ever want.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

As of this morning, March 19, 2020, I’m still working.

Granted, there aren’t a lot of people who want to come in. My schedule has dropped to 3-5 follow-ups per day and no new patients.

I can understand people not wanting to expose themselves unnecessarily right now.

But, I’m still a doctor. What drove me to study for the MCAT, apply to med school 2 years in a row, and then survive medical school, internship, residency, and fellowship ... is still there.

Like I said in my 1987 personal statement, I still want to help people. I’d feel remiss if (provided I don’t have COVID-19) I didn’t show up for work each day, ready to care for any who need me. It’s part of who I am, what I do, and what I believe in.

I’m sure my colleagues in family practice, internal medicine, and pulmonology are swamped right now, but neurologists with primarily outpatient practices are taking a back seat except for a handful of patients.

My small office has been set up for my staff to work remotely in a pinch since 2016, so that was easy to enact. The three of us cover the phones the way we always have, and I see patients here.

With the relaxing of telehealth requirements for Medicare that were announced on March 17, I’m setting up to “see” patients remotely.

The whole situation seems bizarre and surreal.

It’s easy for anyone to read too much into anything. A brief tickle in my throat when I wake up, or a sneeze, or a few coughs, suddenly trigger a flurry of “could I have it?” thoughts. Fortunately, they fade when things quickly return to normal, but a few weeks ago I wouldn’t have thought anything of them at all.

Inevitably, I and pretty much everyone else will be exposed to or catch the virus. It’s what virions do. Unless you absolutely isolate yourself on a desert island, it will happen. When it does, you can only hope for the best.

I’m here for my patients today and will be as long as they need me. Unless I have to go into quarantine, of course. And even then, if able, I’ll do the best I can to treat them remotely.

That’s all I could ever want.
 

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Newly updated guidance on treating patients with the novel coronavirus (COVID-19) has been published by the World Health Organization.

While it can’t replace clinical judgment or specialist consultation, the new guidance may help strengthen the clinical management of patients when COVID-19 is suspected, according to its authors.

The guidance, adapted from an earlier edition focused on the management of suspected Middle East respiratory syndrome coronavirus (MERS-CoV), covers best practices for triage, infection prevention and control, and optimized supportive care for mild, severe, or critical coronavirus disease 2019 (COVID-19).

“This guidance should serve as a foundation for optimized supportive care to ensure the best possible chance for survival,” the authors wrote in the guidance.

Newly updated guidance on treating patients with the novel coronavirus (COVID-19) has been published by the World Health Organization.

While it can’t replace clinical judgment or specialist consultation, the new guidance may help strengthen the clinical management of patients when COVID-19 is suspected, according to its authors.

The guidance, adapted from an earlier edition focused on the management of suspected Middle East respiratory syndrome coronavirus (MERS-CoV), covers best practices for triage, infection prevention and control, and optimized supportive care for mild, severe, or critical coronavirus disease 2019 (COVID-19).

“This guidance should serve as a foundation for optimized supportive care to ensure the best possible chance for survival,” the authors wrote in the guidance.

Newly updated guidance on treating patients with the novel coronavirus (COVID-19) has been published by the World Health Organization.

While it can’t replace clinical judgment or specialist consultation, the new guidance may help strengthen the clinical management of patients when COVID-19 is suspected, according to its authors.

The guidance, adapted from an earlier edition focused on the management of suspected Middle East respiratory syndrome coronavirus (MERS-CoV), covers best practices for triage, infection prevention and control, and optimized supportive care for mild, severe, or critical coronavirus disease 2019 (COVID-19).

“This guidance should serve as a foundation for optimized supportive care to ensure the best possible chance for survival,” the authors wrote in the guidance.

No difference in the primary endpoint of the time to clinical improvement was seen in an open-label trial of the antiretroviral drug lopinavir-ritonavir versus standard of care in adult patients hospitalized with severe COVID-19.

The median time to clinical improvement – defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever was first – was 16 days in both groups (hazard ratio, 1.31; 95% confidence interval 0.95-1.85; P = .09).

Although a numerically lower number of deaths were recorded at 28 days (19.2% vs. 25%) with the antiretroviral treatment versus standard of care, a similar percentage of patients had detectable levels of viral RNA in throat swabs taken at various time points during the study, Chinese researchers reported in the New England Journal of Medicine.

Bai Cao, M.D, from the China-Japan Friendship Hospital and Chinese Academy of Medical Sciences, both in Beijing, and associates, performed a randomized, controlled, trial of 199 adult patients hospitalized at the Jin Yin-Tan Hospital in Wuhan in Hubei Province, China.

For inclusion, patients had to have laboratory confirmed infection with SARS-Cov-2, the virus that causes COVID-19; pneumonia confirmed by chest imaging; and severely reduced oxygen saturation (94% or less while breathing ambient air or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen of less than 300 mm Hg).

Patients were randomized to receive either a combination of lopinavir (400 mg) and ritonavir (100 mg) twice a day on top of standard care (n = 99) or to standard care alone (n = 100) for 14 days. “Because of the emergency nature of the trial, placebos of lopinavir-ritonavir were not prepared,” Dr. Cao et al. explained, noting that standard care consisted of supplemental oxygen, ventilation, antibiotic treatment, vasopressor support, renal-replacement therapy, and extracorporeal membrane oxygenation.

While the trial did not meet its primary endpoint, Dr. Cao et al. reported that patients in the lopinavir-ritonavir group had a shorter stay in the intensive care unit than did those in the standard-care group, at a median of 6 versus 11 days. They also reported that the duration from randomization to hospital discharge was numerically shorter, at a median of 12 versus 14 days. Furthermore, there was a higher percentage of patients with clinical improvement at day 14 in the lopinavir-ritonavir group than in the standard-care group (45.5% vs. 30.0%)

“The trial was initiated in rapid response to the COVID-19 public health emergency, at which time there was very limited information about clinical outcomes in hospitalized patients with COVID-19,” the researchers observed. “The question of whether earlier lopinavir-ritonavir treatment in COVID-19 could have clinical benefit is an important one that requires further study,” they wrote.

Among the trial’s limitations are it was not blinded and the researchers do not have data on the lopinavir exposure levels in the trial participants.

“This was a heroic effort” in a “particularly challenging population,” Lindsey R. Baden, MD, and Eric J. Rubin, MD, stated in an editorial accompanying the article (Baden LR and Rubin EJ. New Engl J Med. March 18, 2020. doi: 10.1056/NEJMe2005477). “Unfortunately, the trial results were disappointing,” they noted.

“The secondary end points provide both reason for hope and reason for discouragement,” wrote Dr. Baden and Dr. Rubin. The lack of effect on viral shedding, however, “strongly [suggests] that it did not have the activity desired” they observed.

Dr. Baden and Dr. Rubin commented that one of the important takeaways from the trial is that “the investigators appropriately prioritized speed, designing a trial that could rapidly produce an answer.” They continued that the investigators had shown that “rapidly initiated, high-quality randomized clinical trials are possible in epidemic conditions” and that results of such trials, whether they are positive or negative, “will be central to clinical care as the dangerous coronavirus outbreak continues.”

As it stands, more than 100 trials are listed in the ClinicalTrials.gov database as testing a wide range of different treatment approaches for COVID-19. These include trials investigating if sarilumab, hydroxychloroquine, fingolimod, bevacizumab, and losartan might have a role to play. There are also trials looking at the potential of other antiviral agents, such as Gilead’s investigational drug remdesivir, which has shown to have in vitro and in vivo activity against many emerging viral pathogens that cause Ebola, Middle Eastern Respiratory Syndrome, and Severe Acute Respiratory Syndrome.

Dr. Cao’s trial was supported by grants from Major Projects of National Science and Technology on New Drug Creation and Development and from the Chinese Academy of Medical Sciences (CAMS) Emergency Project of Covid-19, and a National Science Grant for Distinguished Young Scholars.

All authors had no financial conflicts of interest to disclose.

Dr. Baden is the director of clinical research in the Division of Infectious Diseases at the Brigham and Women’s Hospital and the director of infectious diseases at the Dana-Farber Cancer Institute. He is a deputy editor of the New England Journal of Medicine and chair of the FDA’s Antimicrobial Drug Advisory Committee. He is involved in HIV vaccine clinical trials and has received research grants from the Ragon Institute, the National Institutes of Health/National Institute of Allergy and Infectious Diseases, and the Gates Foundation.

Dr. Rubin is employed by the New England Journal of Medicine as editor-in-chief. He is an associate physician at Brigham and Women’s Hospital and is chair and Irene Heinz Given Professor of Immunology and Infectious Diseases at the Harvard T.H. Chan School of Public Health.

SOURCE: Cao B et al. New Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282.

No difference in the primary endpoint of the time to clinical improvement was seen in an open-label trial of the antiretroviral drug lopinavir-ritonavir versus standard of care in adult patients hospitalized with severe COVID-19.

The median time to clinical improvement – defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever was first – was 16 days in both groups (hazard ratio, 1.31; 95% confidence interval 0.95-1.85; P = .09).

Although a numerically lower number of deaths were recorded at 28 days (19.2% vs. 25%) with the antiretroviral treatment versus standard of care, a similar percentage of patients had detectable levels of viral RNA in throat swabs taken at various time points during the study, Chinese researchers reported in the New England Journal of Medicine.

Bai Cao, M.D, from the China-Japan Friendship Hospital and Chinese Academy of Medical Sciences, both in Beijing, and associates, performed a randomized, controlled, trial of 199 adult patients hospitalized at the Jin Yin-Tan Hospital in Wuhan in Hubei Province, China.

For inclusion, patients had to have laboratory confirmed infection with SARS-Cov-2, the virus that causes COVID-19; pneumonia confirmed by chest imaging; and severely reduced oxygen saturation (94% or less while breathing ambient air or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen of less than 300 mm Hg).

Patients were randomized to receive either a combination of lopinavir (400 mg) and ritonavir (100 mg) twice a day on top of standard care (n = 99) or to standard care alone (n = 100) for 14 days. “Because of the emergency nature of the trial, placebos of lopinavir-ritonavir were not prepared,” Dr. Cao et al. explained, noting that standard care consisted of supplemental oxygen, ventilation, antibiotic treatment, vasopressor support, renal-replacement therapy, and extracorporeal membrane oxygenation.

While the trial did not meet its primary endpoint, Dr. Cao et al. reported that patients in the lopinavir-ritonavir group had a shorter stay in the intensive care unit than did those in the standard-care group, at a median of 6 versus 11 days. They also reported that the duration from randomization to hospital discharge was numerically shorter, at a median of 12 versus 14 days. Furthermore, there was a higher percentage of patients with clinical improvement at day 14 in the lopinavir-ritonavir group than in the standard-care group (45.5% vs. 30.0%)

“The trial was initiated in rapid response to the COVID-19 public health emergency, at which time there was very limited information about clinical outcomes in hospitalized patients with COVID-19,” the researchers observed. “The question of whether earlier lopinavir-ritonavir treatment in COVID-19 could have clinical benefit is an important one that requires further study,” they wrote.

Among the trial’s limitations are it was not blinded and the researchers do not have data on the lopinavir exposure levels in the trial participants.

“This was a heroic effort” in a “particularly challenging population,” Lindsey R. Baden, MD, and Eric J. Rubin, MD, stated in an editorial accompanying the article (Baden LR and Rubin EJ. New Engl J Med. March 18, 2020. doi: 10.1056/NEJMe2005477). “Unfortunately, the trial results were disappointing,” they noted.

“The secondary end points provide both reason for hope and reason for discouragement,” wrote Dr. Baden and Dr. Rubin. The lack of effect on viral shedding, however, “strongly [suggests] that it did not have the activity desired” they observed.

Dr. Baden and Dr. Rubin commented that one of the important takeaways from the trial is that “the investigators appropriately prioritized speed, designing a trial that could rapidly produce an answer.” They continued that the investigators had shown that “rapidly initiated, high-quality randomized clinical trials are possible in epidemic conditions” and that results of such trials, whether they are positive or negative, “will be central to clinical care as the dangerous coronavirus outbreak continues.”

As it stands, more than 100 trials are listed in the ClinicalTrials.gov database as testing a wide range of different treatment approaches for COVID-19. These include trials investigating if sarilumab, hydroxychloroquine, fingolimod, bevacizumab, and losartan might have a role to play. There are also trials looking at the potential of other antiviral agents, such as Gilead’s investigational drug remdesivir, which has shown to have in vitro and in vivo activity against many emerging viral pathogens that cause Ebola, Middle Eastern Respiratory Syndrome, and Severe Acute Respiratory Syndrome.

Dr. Cao’s trial was supported by grants from Major Projects of National Science and Technology on New Drug Creation and Development and from the Chinese Academy of Medical Sciences (CAMS) Emergency Project of Covid-19, and a National Science Grant for Distinguished Young Scholars.

All authors had no financial conflicts of interest to disclose.

Dr. Baden is the director of clinical research in the Division of Infectious Diseases at the Brigham and Women’s Hospital and the director of infectious diseases at the Dana-Farber Cancer Institute. He is a deputy editor of the New England Journal of Medicine and chair of the FDA’s Antimicrobial Drug Advisory Committee. He is involved in HIV vaccine clinical trials and has received research grants from the Ragon Institute, the National Institutes of Health/National Institute of Allergy and Infectious Diseases, and the Gates Foundation.

Dr. Rubin is employed by the New England Journal of Medicine as editor-in-chief. He is an associate physician at Brigham and Women’s Hospital and is chair and Irene Heinz Given Professor of Immunology and Infectious Diseases at the Harvard T.H. Chan School of Public Health.

SOURCE: Cao B et al. New Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282.

No difference in the primary endpoint of the time to clinical improvement was seen in an open-label trial of the antiretroviral drug lopinavir-ritonavir versus standard of care in adult patients hospitalized with severe COVID-19.

The median time to clinical improvement – defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever was first – was 16 days in both groups (hazard ratio, 1.31; 95% confidence interval 0.95-1.85; P = .09).

Although a numerically lower number of deaths were recorded at 28 days (19.2% vs. 25%) with the antiretroviral treatment versus standard of care, a similar percentage of patients had detectable levels of viral RNA in throat swabs taken at various time points during the study, Chinese researchers reported in the New England Journal of Medicine.

Bai Cao, M.D, from the China-Japan Friendship Hospital and Chinese Academy of Medical Sciences, both in Beijing, and associates, performed a randomized, controlled, trial of 199 adult patients hospitalized at the Jin Yin-Tan Hospital in Wuhan in Hubei Province, China.

For inclusion, patients had to have laboratory confirmed infection with SARS-Cov-2, the virus that causes COVID-19; pneumonia confirmed by chest imaging; and severely reduced oxygen saturation (94% or less while breathing ambient air or a ratio of the partial pressure of oxygen to the fraction of inspired oxygen of less than 300 mm Hg).

Patients were randomized to receive either a combination of lopinavir (400 mg) and ritonavir (100 mg) twice a day on top of standard care (n = 99) or to standard care alone (n = 100) for 14 days. “Because of the emergency nature of the trial, placebos of lopinavir-ritonavir were not prepared,” Dr. Cao et al. explained, noting that standard care consisted of supplemental oxygen, ventilation, antibiotic treatment, vasopressor support, renal-replacement therapy, and extracorporeal membrane oxygenation.

While the trial did not meet its primary endpoint, Dr. Cao et al. reported that patients in the lopinavir-ritonavir group had a shorter stay in the intensive care unit than did those in the standard-care group, at a median of 6 versus 11 days. They also reported that the duration from randomization to hospital discharge was numerically shorter, at a median of 12 versus 14 days. Furthermore, there was a higher percentage of patients with clinical improvement at day 14 in the lopinavir-ritonavir group than in the standard-care group (45.5% vs. 30.0%)

“The trial was initiated in rapid response to the COVID-19 public health emergency, at which time there was very limited information about clinical outcomes in hospitalized patients with COVID-19,” the researchers observed. “The question of whether earlier lopinavir-ritonavir treatment in COVID-19 could have clinical benefit is an important one that requires further study,” they wrote.

Among the trial’s limitations are it was not blinded and the researchers do not have data on the lopinavir exposure levels in the trial participants.

“This was a heroic effort” in a “particularly challenging population,” Lindsey R. Baden, MD, and Eric J. Rubin, MD, stated in an editorial accompanying the article (Baden LR and Rubin EJ. New Engl J Med. March 18, 2020. doi: 10.1056/NEJMe2005477). “Unfortunately, the trial results were disappointing,” they noted.

“The secondary end points provide both reason for hope and reason for discouragement,” wrote Dr. Baden and Dr. Rubin. The lack of effect on viral shedding, however, “strongly [suggests] that it did not have the activity desired” they observed.

Dr. Baden and Dr. Rubin commented that one of the important takeaways from the trial is that “the investigators appropriately prioritized speed, designing a trial that could rapidly produce an answer.” They continued that the investigators had shown that “rapidly initiated, high-quality randomized clinical trials are possible in epidemic conditions” and that results of such trials, whether they are positive or negative, “will be central to clinical care as the dangerous coronavirus outbreak continues.”

As it stands, more than 100 trials are listed in the ClinicalTrials.gov database as testing a wide range of different treatment approaches for COVID-19. These include trials investigating if sarilumab, hydroxychloroquine, fingolimod, bevacizumab, and losartan might have a role to play. There are also trials looking at the potential of other antiviral agents, such as Gilead’s investigational drug remdesivir, which has shown to have in vitro and in vivo activity against many emerging viral pathogens that cause Ebola, Middle Eastern Respiratory Syndrome, and Severe Acute Respiratory Syndrome.

Dr. Cao’s trial was supported by grants from Major Projects of National Science and Technology on New Drug Creation and Development and from the Chinese Academy of Medical Sciences (CAMS) Emergency Project of Covid-19, and a National Science Grant for Distinguished Young Scholars.

All authors had no financial conflicts of interest to disclose.

Dr. Baden is the director of clinical research in the Division of Infectious Diseases at the Brigham and Women’s Hospital and the director of infectious diseases at the Dana-Farber Cancer Institute. He is a deputy editor of the New England Journal of Medicine and chair of the FDA’s Antimicrobial Drug Advisory Committee. He is involved in HIV vaccine clinical trials and has received research grants from the Ragon Institute, the National Institutes of Health/National Institute of Allergy and Infectious Diseases, and the Gates Foundation.

Dr. Rubin is employed by the New England Journal of Medicine as editor-in-chief. He is an associate physician at Brigham and Women’s Hospital and is chair and Irene Heinz Given Professor of Immunology and Infectious Diseases at the Harvard T.H. Chan School of Public Health.

SOURCE: Cao B et al. New Engl J Med. 2020 Mar 18. doi: 10.1056/NEJMoa2001282.

Patients with COVID-19 may be at risk for liver injury, but mechanisms of damage remain unclear, according to investigators.

Proposed mechanisms include direct virus-induced effects, immune-induced damage due to excessive inflammatory responses, and drug-induced injury, reported lead author Ling Xu of Huazhong University of Science and Technology, Wuhan, China, and colleagues.

“From a clinical perspective, in addition to actively dealing with the primary disease caused by coronavirus infection, attention should also be paid to monitor the occurrence of liver injury, and to the application of drugs which may induce liver damage,” the investigators wrote in Liver International. “Patients with liver damage are advised to be treated with drugs that could both protect liver functions and inhibit inflammatory responses, such as ammonium glycyrrhizinate, which may, in turn, accelerate the process of disease recovery.”

The review of liver injury associated with major pathogenic coronaviruses included severe acute respiratory syndrome coronavirus (SARS-CoV), the Middle East respiratory syndrome coronavirus (MERS-CoV), and the newly emergent SARS-CoV-2, which causes COVID-19.

In cases of COVID-19, reported incidence of liver injury ranges from 15% to 53%, based on elevations of alanine transaminase (ALT) and aspartate aminotransferase (AST), along with slightly elevated bilirubin levels. In severe cases, albumin decreases have also been documented.

Liver injury appears to be significantly more common among those with severe infection. In one cohort of 82 patients who died from COVID-19, the incidence of liver injury was 78%, while another study of 36 nonsurvivors reported a rate of 58%.

According to the investigators, both bile duct epithelial cells and liver cells express angiotensin converting enzyme II (ACE2), which is an entry receptor for SARS-CoV-2; however, expression of ACE2 in bile duct cells is “much higher” than in liver cells, and comparable with alveolar type 2 cells in the lungs.

“Bile duct epithelial cells are known to play important roles in liver regeneration and immune response,” the investigators noted.

Beyond direct- and immune-induced effects of COVID-19, postmortem findings suggest that drug-induced liver injury may also be a possibility, with a number of theoretical culprits, including antibiotics, steroids, and antivirals. Although the investigators emphasized that data are insufficient to pinpoint an exact agent, they highlighted a recent preprint study, which reported a significantly higher rate of lopinavir/ritonavir administration among patients with abnormal liver function, compared with those who had normal liver function (56.1% vs. 25%; P = .009).

“Drug-induced liver injury during the treatment of coronavirus infection should not be ignored and needs to be carefully investigated,” the investigators concluded.

Fundamental Research Funds for the Central Universities supported the work. The investigators reported no conflicts of interest.

SOURCE: Xu L et al. Liver Int. 2020 Mar 14. doi: 10.1111/liv.14435.

Patients with COVID-19 may be at risk for liver injury, but mechanisms of damage remain unclear, according to investigators.

Proposed mechanisms include direct virus-induced effects, immune-induced damage due to excessive inflammatory responses, and drug-induced injury, reported lead author Ling Xu of Huazhong University of Science and Technology, Wuhan, China, and colleagues.

“From a clinical perspective, in addition to actively dealing with the primary disease caused by coronavirus infection, attention should also be paid to monitor the occurrence of liver injury, and to the application of drugs which may induce liver damage,” the investigators wrote in Liver International. “Patients with liver damage are advised to be treated with drugs that could both protect liver functions and inhibit inflammatory responses, such as ammonium glycyrrhizinate, which may, in turn, accelerate the process of disease recovery.”

The review of liver injury associated with major pathogenic coronaviruses included severe acute respiratory syndrome coronavirus (SARS-CoV), the Middle East respiratory syndrome coronavirus (MERS-CoV), and the newly emergent SARS-CoV-2, which causes COVID-19.

In cases of COVID-19, reported incidence of liver injury ranges from 15% to 53%, based on elevations of alanine transaminase (ALT) and aspartate aminotransferase (AST), along with slightly elevated bilirubin levels. In severe cases, albumin decreases have also been documented.

Liver injury appears to be significantly more common among those with severe infection. In one cohort of 82 patients who died from COVID-19, the incidence of liver injury was 78%, while another study of 36 nonsurvivors reported a rate of 58%.

According to the investigators, both bile duct epithelial cells and liver cells express angiotensin converting enzyme II (ACE2), which is an entry receptor for SARS-CoV-2; however, expression of ACE2 in bile duct cells is “much higher” than in liver cells, and comparable with alveolar type 2 cells in the lungs.

“Bile duct epithelial cells are known to play important roles in liver regeneration and immune response,” the investigators noted.

Beyond direct- and immune-induced effects of COVID-19, postmortem findings suggest that drug-induced liver injury may also be a possibility, with a number of theoretical culprits, including antibiotics, steroids, and antivirals. Although the investigators emphasized that data are insufficient to pinpoint an exact agent, they highlighted a recent preprint study, which reported a significantly higher rate of lopinavir/ritonavir administration among patients with abnormal liver function, compared with those who had normal liver function (56.1% vs. 25%; P = .009).

“Drug-induced liver injury during the treatment of coronavirus infection should not be ignored and needs to be carefully investigated,” the investigators concluded.

Fundamental Research Funds for the Central Universities supported the work. The investigators reported no conflicts of interest.

SOURCE: Xu L et al. Liver Int. 2020 Mar 14. doi: 10.1111/liv.14435.

Patients with COVID-19 may be at risk for liver injury, but mechanisms of damage remain unclear, according to investigators.

Proposed mechanisms include direct virus-induced effects, immune-induced damage due to excessive inflammatory responses, and drug-induced injury, reported lead author Ling Xu of Huazhong University of Science and Technology, Wuhan, China, and colleagues.

“From a clinical perspective, in addition to actively dealing with the primary disease caused by coronavirus infection, attention should also be paid to monitor the occurrence of liver injury, and to the application of drugs which may induce liver damage,” the investigators wrote in Liver International. “Patients with liver damage are advised to be treated with drugs that could both protect liver functions and inhibit inflammatory responses, such as ammonium glycyrrhizinate, which may, in turn, accelerate the process of disease recovery.”

The review of liver injury associated with major pathogenic coronaviruses included severe acute respiratory syndrome coronavirus (SARS-CoV), the Middle East respiratory syndrome coronavirus (MERS-CoV), and the newly emergent SARS-CoV-2, which causes COVID-19.

In cases of COVID-19, reported incidence of liver injury ranges from 15% to 53%, based on elevations of alanine transaminase (ALT) and aspartate aminotransferase (AST), along with slightly elevated bilirubin levels. In severe cases, albumin decreases have also been documented.

Liver injury appears to be significantly more common among those with severe infection. In one cohort of 82 patients who died from COVID-19, the incidence of liver injury was 78%, while another study of 36 nonsurvivors reported a rate of 58%.

According to the investigators, both bile duct epithelial cells and liver cells express angiotensin converting enzyme II (ACE2), which is an entry receptor for SARS-CoV-2; however, expression of ACE2 in bile duct cells is “much higher” than in liver cells, and comparable with alveolar type 2 cells in the lungs.

“Bile duct epithelial cells are known to play important roles in liver regeneration and immune response,” the investigators noted.

Beyond direct- and immune-induced effects of COVID-19, postmortem findings suggest that drug-induced liver injury may also be a possibility, with a number of theoretical culprits, including antibiotics, steroids, and antivirals. Although the investigators emphasized that data are insufficient to pinpoint an exact agent, they highlighted a recent preprint study, which reported a significantly higher rate of lopinavir/ritonavir administration among patients with abnormal liver function, compared with those who had normal liver function (56.1% vs. 25%; P = .009).

“Drug-induced liver injury during the treatment of coronavirus infection should not be ignored and needs to be carefully investigated,” the investigators concluded.

Fundamental Research Funds for the Central Universities supported the work. The investigators reported no conflicts of interest.

SOURCE: Xu L et al. Liver Int. 2020 Mar 14. doi: 10.1111/liv.14435.

In a JAMA Live Stream interview, Anthony S. Fauci, MD, a key member of the White House Coronavirus Task Force, urged resolve, rather than panic, as the coronavirus pandemic takes hold in the United States.

Dr. Fauci got into the details of what is known, what is unknown, what is being done in laboratories, and what clinical elements are still not understood about this disease.

The next several weeks, he said, are likely to tell the tale of whether our health care system is up to the challenge of care for the most ill among those who will be affected by COVID-19.

“It shouldn’t panic or frighten us, but we have to know we’re dealing with a very serious problem that we have to address, and we have to deal with it in a very bold way,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Speaking in an interview with JAMA Editor in Chief Howard Bauchner, MD, Dr. Fauci said the situation favors action over fear. “Let’s apply that energy to doing the things that we know can mitigate this.”

He added that he heard the message loud and clear from health care leaders in Italy and France during a World Health Organization coronavirus call earlier in the day. Officials in those countries, he said, were “almost pleading with the rest of the world to please take this very seriously, because it happens all of a sudden – very abruptly. ... The best time to mitigate is before that happens, because if you wait until after it happens you’re playing catch-up.”

Dr. Bauchner, noting that strict social distancing has been underway in many parts of the United States for several days, posited that, by early April, “We’ll really have a sense if we can manage in terms of serious illness.” Seattle, New York, Boston, and the San Francisco Bay Area may experience demand that outstrips ICU capacity at that point, but the rest of the country, he said, “is doing relatively well.”
 

Stress test on the health care system

Dr. Fauci agreed with this statement and added: “We’re going to know – for better or worse – whether we have enough of what it takes to be able to practice the kind of medicine that we optimally would want to practice.

In the matter of a week or 2 ... I think we’ll get a feel for whether or not we really have enough of the supplies that it takes.”

The well-publicized regional shortages in personal protective equipment (PPE) are forcing tough choices in some areas. As expedited – and even drive-through – testing begins, some of the demand for testing-related PPE may abate, especially if protocols include self-administration of nasal swabs, he noted.

Dr. Fauci added that the strategic national stockpile of medical supplies and equipment has not yet been tapped, “but you need to backfill that as quickly as you can once you start drawing from the strategic national stockpile.”
 

Returning to work after COVID-19 infection

Regarding the thorny question of when health care workers should be permitted to return to work after coronavirus infection, “it’s an evolving story,” said Dr. Fauci. Current guidance advises that health care providers stay away from work until two negative tests after resolution of fever and improvement of respiratory symptoms, or 3 fever-free days.

“We are approaching a point where you’re going to get enough people who are getting infected that we aren’t going to be able to do that,” he said. Depending on the stress to the health care system in a given locality, he said that facilities are going to have to “decide with good judgment” when health care workers go back on the job after coronavirus infection.

Asked how soon an individual would reliably test positive for COVID-19 after exposure, Dr. Fauci said, “We don’t know the answer to that. ... We can surmise it ...” He noted that it’s a median of about 5 days with a range of 2 to 14 days, before an infected individual becomes symptomatic. “I can say it’s not going to happen immediately,” he added, noting that he wouldn’t expect to see a positive test until about 2 days after exposure at the earliest. “When you get to the point where you are symptomatic, you’re almost certainly going to be positive then. ... This is just an extrapolation,” rather than conclusions drawn from solid data, he emphasized.
 

Higher risk reported in cardiac patients

Dr. Bauchner, who was relaying questions sent in from physicians during the live-streamed interview, asked about a newly issued joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America, which on March 17 affirmed that individuals on ACE inhibitors and angiotensin receptor blockers (ARBs) continue that therapy if they should become ill with COVID-19. The European Society of Cardiology issued a similar recommendation a few days prior.

Despite these societies’ statements, Dr. Fauci pointed to population-level data in Italy as suggesting that the case isn’t yet closed. “We really need to get data, and we need to get data fast. There’s a mechanistic rationale for the concern. It’s there, and it’s firm,” he said. The theoretical concern is that ACE inhibitors can upregulate expression of the ACE-2 protein on cell membranes, which is the entry point for SARS-Cov-2 to enter cells.

He added that he remains concerned about the number of coronavirus fatalities of patients in Italy who had hypertension as their only, or primary, underlying health problem.“That to me was a bit of a red flag,” he said. “Patients with hypertension almost certainly had a physician, and the physician almost certainly treated that person with medication. Why should someone who has hypertension that was well controlled have a much greater chance of dying?” he asked, noting that “I look at a person with well-controlled hypertension as a relatively healthy person. I don’t know what the answer is, but somebody has to look very carefully,” ideally by means of a natural history study that identifies medications used by those who died from coronavirus.
 

Potential therapies

Regarding potential therapies for COVID-19, Dr. Fauci acknowledged the social media buzz and flurry of medical letters and case reports about the use of hydroxychloroquine (Plaquenil) to treat active infection. He said that he and other researchers are “in active discussion” about how best to study the efficacy and safety of hydroxychloroquine, but he also acknowledged that many treating clinicians will use hydroxychloroquine empirically in the absence of other treatments with proven efficacy.

Clinical trials underway in China for antiviral medication are facing some enrollment challenges currently “because people want to get the drug,” said Dr. Fauci. “They don’t want to be in the trial; they just want to get the drug.” Though each of two trials has targeted approximately 500 participants as the number needed for sufficient statistical power, Dr. Fauci urged Chinese data safety monitoring boards to “take a close look” at the data already accrued for the several hundred patients who have already enrolled for the studies “to see if there’s any hint of efficacy.”

[email protected]

In a JAMA Live Stream interview, Anthony S. Fauci, MD, a key member of the White House Coronavirus Task Force, urged resolve, rather than panic, as the coronavirus pandemic takes hold in the United States.

Dr. Fauci got into the details of what is known, what is unknown, what is being done in laboratories, and what clinical elements are still not understood about this disease.

The next several weeks, he said, are likely to tell the tale of whether our health care system is up to the challenge of care for the most ill among those who will be affected by COVID-19.

“It shouldn’t panic or frighten us, but we have to know we’re dealing with a very serious problem that we have to address, and we have to deal with it in a very bold way,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Speaking in an interview with JAMA Editor in Chief Howard Bauchner, MD, Dr. Fauci said the situation favors action over fear. “Let’s apply that energy to doing the things that we know can mitigate this.”

He added that he heard the message loud and clear from health care leaders in Italy and France during a World Health Organization coronavirus call earlier in the day. Officials in those countries, he said, were “almost pleading with the rest of the world to please take this very seriously, because it happens all of a sudden – very abruptly. ... The best time to mitigate is before that happens, because if you wait until after it happens you’re playing catch-up.”

Dr. Bauchner, noting that strict social distancing has been underway in many parts of the United States for several days, posited that, by early April, “We’ll really have a sense if we can manage in terms of serious illness.” Seattle, New York, Boston, and the San Francisco Bay Area may experience demand that outstrips ICU capacity at that point, but the rest of the country, he said, “is doing relatively well.”
 

Stress test on the health care system

Dr. Fauci agreed with this statement and added: “We’re going to know – for better or worse – whether we have enough of what it takes to be able to practice the kind of medicine that we optimally would want to practice.

In the matter of a week or 2 ... I think we’ll get a feel for whether or not we really have enough of the supplies that it takes.”

The well-publicized regional shortages in personal protective equipment (PPE) are forcing tough choices in some areas. As expedited – and even drive-through – testing begins, some of the demand for testing-related PPE may abate, especially if protocols include self-administration of nasal swabs, he noted.

Dr. Fauci added that the strategic national stockpile of medical supplies and equipment has not yet been tapped, “but you need to backfill that as quickly as you can once you start drawing from the strategic national stockpile.”
 

Returning to work after COVID-19 infection

Regarding the thorny question of when health care workers should be permitted to return to work after coronavirus infection, “it’s an evolving story,” said Dr. Fauci. Current guidance advises that health care providers stay away from work until two negative tests after resolution of fever and improvement of respiratory symptoms, or 3 fever-free days.

“We are approaching a point where you’re going to get enough people who are getting infected that we aren’t going to be able to do that,” he said. Depending on the stress to the health care system in a given locality, he said that facilities are going to have to “decide with good judgment” when health care workers go back on the job after coronavirus infection.

Asked how soon an individual would reliably test positive for COVID-19 after exposure, Dr. Fauci said, “We don’t know the answer to that. ... We can surmise it ...” He noted that it’s a median of about 5 days with a range of 2 to 14 days, before an infected individual becomes symptomatic. “I can say it’s not going to happen immediately,” he added, noting that he wouldn’t expect to see a positive test until about 2 days after exposure at the earliest. “When you get to the point where you are symptomatic, you’re almost certainly going to be positive then. ... This is just an extrapolation,” rather than conclusions drawn from solid data, he emphasized.
 

Higher risk reported in cardiac patients

Dr. Bauchner, who was relaying questions sent in from physicians during the live-streamed interview, asked about a newly issued joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America, which on March 17 affirmed that individuals on ACE inhibitors and angiotensin receptor blockers (ARBs) continue that therapy if they should become ill with COVID-19. The European Society of Cardiology issued a similar recommendation a few days prior.

Despite these societies’ statements, Dr. Fauci pointed to population-level data in Italy as suggesting that the case isn’t yet closed. “We really need to get data, and we need to get data fast. There’s a mechanistic rationale for the concern. It’s there, and it’s firm,” he said. The theoretical concern is that ACE inhibitors can upregulate expression of the ACE-2 protein on cell membranes, which is the entry point for SARS-Cov-2 to enter cells.

He added that he remains concerned about the number of coronavirus fatalities of patients in Italy who had hypertension as their only, or primary, underlying health problem.“That to me was a bit of a red flag,” he said. “Patients with hypertension almost certainly had a physician, and the physician almost certainly treated that person with medication. Why should someone who has hypertension that was well controlled have a much greater chance of dying?” he asked, noting that “I look at a person with well-controlled hypertension as a relatively healthy person. I don’t know what the answer is, but somebody has to look very carefully,” ideally by means of a natural history study that identifies medications used by those who died from coronavirus.
 

Potential therapies

Regarding potential therapies for COVID-19, Dr. Fauci acknowledged the social media buzz and flurry of medical letters and case reports about the use of hydroxychloroquine (Plaquenil) to treat active infection. He said that he and other researchers are “in active discussion” about how best to study the efficacy and safety of hydroxychloroquine, but he also acknowledged that many treating clinicians will use hydroxychloroquine empirically in the absence of other treatments with proven efficacy.

Clinical trials underway in China for antiviral medication are facing some enrollment challenges currently “because people want to get the drug,” said Dr. Fauci. “They don’t want to be in the trial; they just want to get the drug.” Though each of two trials has targeted approximately 500 participants as the number needed for sufficient statistical power, Dr. Fauci urged Chinese data safety monitoring boards to “take a close look” at the data already accrued for the several hundred patients who have already enrolled for the studies “to see if there’s any hint of efficacy.”

[email protected]

In a JAMA Live Stream interview, Anthony S. Fauci, MD, a key member of the White House Coronavirus Task Force, urged resolve, rather than panic, as the coronavirus pandemic takes hold in the United States.

Dr. Fauci got into the details of what is known, what is unknown, what is being done in laboratories, and what clinical elements are still not understood about this disease.

The next several weeks, he said, are likely to tell the tale of whether our health care system is up to the challenge of care for the most ill among those who will be affected by COVID-19.

“It shouldn’t panic or frighten us, but we have to know we’re dealing with a very serious problem that we have to address, and we have to deal with it in a very bold way,” said Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Speaking in an interview with JAMA Editor in Chief Howard Bauchner, MD, Dr. Fauci said the situation favors action over fear. “Let’s apply that energy to doing the things that we know can mitigate this.”

He added that he heard the message loud and clear from health care leaders in Italy and France during a World Health Organization coronavirus call earlier in the day. Officials in those countries, he said, were “almost pleading with the rest of the world to please take this very seriously, because it happens all of a sudden – very abruptly. ... The best time to mitigate is before that happens, because if you wait until after it happens you’re playing catch-up.”

Dr. Bauchner, noting that strict social distancing has been underway in many parts of the United States for several days, posited that, by early April, “We’ll really have a sense if we can manage in terms of serious illness.” Seattle, New York, Boston, and the San Francisco Bay Area may experience demand that outstrips ICU capacity at that point, but the rest of the country, he said, “is doing relatively well.”
 

Stress test on the health care system

Dr. Fauci agreed with this statement and added: “We’re going to know – for better or worse – whether we have enough of what it takes to be able to practice the kind of medicine that we optimally would want to practice.

In the matter of a week or 2 ... I think we’ll get a feel for whether or not we really have enough of the supplies that it takes.”

The well-publicized regional shortages in personal protective equipment (PPE) are forcing tough choices in some areas. As expedited – and even drive-through – testing begins, some of the demand for testing-related PPE may abate, especially if protocols include self-administration of nasal swabs, he noted.

Dr. Fauci added that the strategic national stockpile of medical supplies and equipment has not yet been tapped, “but you need to backfill that as quickly as you can once you start drawing from the strategic national stockpile.”
 

Returning to work after COVID-19 infection

Regarding the thorny question of when health care workers should be permitted to return to work after coronavirus infection, “it’s an evolving story,” said Dr. Fauci. Current guidance advises that health care providers stay away from work until two negative tests after resolution of fever and improvement of respiratory symptoms, or 3 fever-free days.

“We are approaching a point where you’re going to get enough people who are getting infected that we aren’t going to be able to do that,” he said. Depending on the stress to the health care system in a given locality, he said that facilities are going to have to “decide with good judgment” when health care workers go back on the job after coronavirus infection.

Asked how soon an individual would reliably test positive for COVID-19 after exposure, Dr. Fauci said, “We don’t know the answer to that. ... We can surmise it ...” He noted that it’s a median of about 5 days with a range of 2 to 14 days, before an infected individual becomes symptomatic. “I can say it’s not going to happen immediately,” he added, noting that he wouldn’t expect to see a positive test until about 2 days after exposure at the earliest. “When you get to the point where you are symptomatic, you’re almost certainly going to be positive then. ... This is just an extrapolation,” rather than conclusions drawn from solid data, he emphasized.
 

Higher risk reported in cardiac patients

Dr. Bauchner, who was relaying questions sent in from physicians during the live-streamed interview, asked about a newly issued joint statement from the American Heart Association, American College of Cardiology, and the Heart Failure Society of America, which on March 17 affirmed that individuals on ACE inhibitors and angiotensin receptor blockers (ARBs) continue that therapy if they should become ill with COVID-19. The European Society of Cardiology issued a similar recommendation a few days prior.

Despite these societies’ statements, Dr. Fauci pointed to population-level data in Italy as suggesting that the case isn’t yet closed. “We really need to get data, and we need to get data fast. There’s a mechanistic rationale for the concern. It’s there, and it’s firm,” he said. The theoretical concern is that ACE inhibitors can upregulate expression of the ACE-2 protein on cell membranes, which is the entry point for SARS-Cov-2 to enter cells.

He added that he remains concerned about the number of coronavirus fatalities of patients in Italy who had hypertension as their only, or primary, underlying health problem.“That to me was a bit of a red flag,” he said. “Patients with hypertension almost certainly had a physician, and the physician almost certainly treated that person with medication. Why should someone who has hypertension that was well controlled have a much greater chance of dying?” he asked, noting that “I look at a person with well-controlled hypertension as a relatively healthy person. I don’t know what the answer is, but somebody has to look very carefully,” ideally by means of a natural history study that identifies medications used by those who died from coronavirus.
 

Potential therapies

Regarding potential therapies for COVID-19, Dr. Fauci acknowledged the social media buzz and flurry of medical letters and case reports about the use of hydroxychloroquine (Plaquenil) to treat active infection. He said that he and other researchers are “in active discussion” about how best to study the efficacy and safety of hydroxychloroquine, but he also acknowledged that many treating clinicians will use hydroxychloroquine empirically in the absence of other treatments with proven efficacy.

Clinical trials underway in China for antiviral medication are facing some enrollment challenges currently “because people want to get the drug,” said Dr. Fauci. “They don’t want to be in the trial; they just want to get the drug.” Though each of two trials has targeted approximately 500 participants as the number needed for sufficient statistical power, Dr. Fauci urged Chinese data safety monitoring boards to “take a close look” at the data already accrued for the several hundred patients who have already enrolled for the studies “to see if there’s any hint of efficacy.”

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