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APRIL 24, 2020 -- In the face of the rapidly evolving COVID-19 pandemic and the absence of FDA-approved treatments, the National Institutes of Health (NIH) has issued "living" treatment guidelines. The recommendations will be updated online as new data from peer-reviewed publications and other authoritative information become available.
A multidisciplinary panel of 30 scientific, clinical, and government experts started working on the guidelines in late March. They released the first iteration online yesterday. Other groups, including the Infectious Diseases Society of America, have previously provided treatment summaries or recommendations.
The current NIH guidelines were by compiled by working groups with expertise in different areas. As per the standard process for establishing clinical guidelines, these groups systematically reviewed all relevant, credible information and scientific publications and made three levels of recommendation of varying strength on the basis of strength of evidence from randomized and nonrandomized clinical trials, well-designed observational studies, and expert opinion.
"There are not a lot of data out there to guide us, so we had to rely a lot on expert opinion," said panel co-chair Roy M. Gulick, MD, MPH, a professor of medicine and chief of infectious diseases at Weill Cornell Medicine in New York City. "We have to face the reality that we don't yet have the controlled clinical data we need in order to say whether something works. But we asked ourselves whether guidelines were needed now, and we decided that we do need to provide guidance for clinicians facing critical patients and wanting to do something to help them."
"At this moment the main sentiment we want to convey is that there are no licensed treatments for COVID-19, but there are a lot of good ideas. And the sooner we can test them, the sooner we can update the guidelines," panel co-chair H. Clifford Lane, MD, clinical director of the National Institute of Allergy and Infectious Diseases, told Medscape Medical News.
The panel hopes to have results from clinical drug trials within a matter of weeks.
"We're expecting data soon from randomized clinical trials [RCTs] of remdesivir and also data from RCTs of hydroxychloroquine, and these are the first things on the horizon that will help us refine these recommendations," Lane added.
In the meantime, "I hope treating practitioners will see these as guidelines, not prescriptions ? information they can use to talk with patients about what makes sense for each individual patient. Each decision about treatment is between the healthcare provider and the patient, and we hope this will help them make that decision without telling them what that decision should be."
"[W]henever possible, the Panel recommends that promising, unapproved or unlicensed treatments for COVID-19 be studied in well-designed controlled trials," the panelists write. They acknowledge, however, that many providers will be unable to access such trials and need guidance on whether to use these agents.
The guidelines address two much-discussed categories of drug treatment, antivirals and immunomodulators. Overall, the panel concluded that the data are insufficient to recommend for or against any antiviral or immunomodulatory therapy for patients with severe COVID-19, nor are there sufficient data to recommend for or against any broad-spectrum antimicrobial agent in the absence of an existing indication.
Among other specific recommendations: There are insufficient clinical data to recommend for or against the use of chloroquine or hydroxychloroquine for the treatment of COVID-19. If used, however, clinicians should monitor patients for adverse effects, especially prolonged QT interval. Data are also inadequate to recommend for or against the investigational broad-spectrum antiviral remdesivir (Gilead Sciences). Originally developed for Ebola and Middle East respiratory syndrome (MERS), this antiviral is currently in clinical trials for COVID-19 and has been made available to some patients on a compassionate use basis. (Researchers recently reported early results for remdesivir among these patients.) Outside of the trial setting, the use of the combination hydroxychloroquine plus azithromycin is not recommended because of potential toxicities, nor is the HIV protease inhibitor lopinavir/ritonavir (Kaletra, AbbVie) because of unfavorable pharmacodynamics and negative clinical trial data. Clinical data are insufficient to recommend for or against the use of convalescent plasma or hyperimmune immunoglobulin for the treatment of COVID-19. Data are also insufficient as to the use of interleukin-6 inhibitors, such as tocilizumab, and interleukin-1 inhibitors, such as anakinra. Clinical trials aside, the panel recommends against using other immunomodulators, such as interferons, because of their toxicity and the fact that they have been shown to be ineffective in the treatment of severe acute respiratory distress syndrome (ARDS) and MERS. Similarly, the panel recommends against use of Janus kinase inhibitors, such as baricitinib, because of their broad immunosuppressive effects. The panelists recommend against the routine use of systemic corticosteroids for mechanically ventilated COVID-19 patients without ARDS, but they endorse the use of low-dose therapy for adults with COVID-19 who are experiencing refractory shock. Corticosteroids or nonsteroidal anti-inflammatory drugs should not be discontinued for COVID-19 patients who are already taking these drugs for other conditions. The guidelines also advise against the use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers for COVID-19 patients, but these drugs should be continued for patients who are already taking them for cardiovascular and other conditions. Similarly, statins should be continued in those taking them for preexisting conditions but should not be prescribed for COVID-19 outside of clinical trials. Data are insufficient to recommend for or against the routine use of extracorporeal membrane oxygenation for patients with COVID-19 who are experiencing refractory hypoxemia. The guideline panel includes representatives from federal agencies, healthcare and academic organizations, and professional medical societies across the spectrum of relevant specialities from critical care and thoracic medicine to pediatric infectious diseases and infectious-disease pharmacy.
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