NIH panel issues COVID-19 treatment guidelines highlighting lack of data for antiviral, immunomodulatory therapies under investigation

A panel of medical experts convened by the US National Institutes of Health (NIH) has drafted treatment guidelines for COVID-19, saying there is not enough evidence for several therapeutic options currently under investigation. However, the guidance, which focuses on antivirals as well as host modifiers and immune-based therapies, is being described by the NIH as a "living document” that is expected to be updated often as new clinical data become available.

At the moment, the panel said that except in the context of a clinical trial, it is recommending against use of the antimalarial hydroxychloroquine plus the antibiotic azithromycin to treat COVID-19 patients due to the "potential for toxicities." It is advising the same regarding the combination of lopinavir and ritonavir or other HIV protease inhibitors, citing "unfavourable pharmacodynamics and negative clinical trial data." US President Donald Trump recently touted use of hydroxychloroquine plus azithromycin as potentially "one of the biggest game-changers in the history of medicine" and urged them to be deployed.

Meanwhile, the panel noted that there is insufficient evidence to recommend either for or against using hydroxychloroquine, related drug chloroquine, or Gilead Sciences' experimental antiviral remdesivir to treat SARS-CoV-2 infection. The FDA issued an emergency-use authorisation late last month to allow hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile to be used to treat hospitalised adults and adolescents with COVID-19. Meanwhile, a recent leaked report suggested patients with COVID-19 who were treated with remdesivir were "seeing rapid recoveries in fever and respiratory symptoms" in a Phase III trial being run out of the University of Chicago. Gilead's drug is currently available through expanded access and compassionate use mechanisms.

The NIH panel also stated there is not enough clinical evidence to recommend either for or against the use of convalescent plasma or hyperimmune immunoglobulin to treat COVID-19. The same goes for IL-6 inhibitors such as Sanofi and Regeneron Pharmaceuticals' Kevzara (sarilumab), Roche's Actemra (tocilizumab) and Johnson & Johnson's Sylvant (siltuximab), and IL-1 inhibitors such as Swedish Orphan Biovitrum's Kineret (anakinra). However, outside of clinical trials, the group did come out against use of interferons to treat COVID-19 patients, citing toxicity as well as a lack of efficacy in treating SARS and MERS infections. Similarly, it is not recommending JAK inhibitors such as Eli Lilly's Olumiant (baricitinib) either "because of their broad immunosuppressive effect."

For additional analysis, see ViewPoints: Optimism accumulates well ahead of COVID-19 progress. Also be sure to have a listen to our latest podcast from FirstWord executive editors Simon King and Michael Flanagan, which includes a discussion of further potential treatment options and the politicisation of different approaches in the absence of meaningful data from controlled clinical studies.

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