Remdesivir Trials Suggest Potential Benefit in COVID-19; FDA Expected to Authorize the Drug

By Amy Orciari Herman

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM

Findings from several trials of remdesivir for novel coronavirus disease (COVID-19) were announced on Wednesday.

The National Institutes of Health reported preliminary findings from a randomized, placebo-controlled trial of intravenous remdesivir in nearly 1100 patients hospitalized with COVID-19 with lung involvement, including those requiring supplemental oxygen or mechanical ventilation. An interim analysis found that the median time to recovery — that is, no longer requiring oxygen or hospitalization — was 31% faster with remdesivir than placebo (11 vs. 15 days). The mortality rate was 8.0% with remdesivir and 11.6% with placebo (p=0.059). The New York Times reports that the FDA plans to authorize emergency use of the drug.

Separately, the Lancet published findings from an underpowered, randomized trial of remdesivir. Nearly 240 adults in China with severe COVID-19 who were within 12 days of symptom onset were randomized to receive intravenous remdesivir or placebo for 10 days. (The study aimed to enroll roughly 450 patients, but recruitment was stopped early as the outbreak came under control in Wuhan.) The primary outcome — time to clinical improvement within 28 days after randomization — did not differ significantly between the remdesivir and placebo groups (median: 21 and 23 days, respectively). However, the researchers note they “could not exclude clinically meaningful differences and saw numerical reductions in some clinical parameters” — for example, among patients treated within 10 days of symptom onset, time to clinical improvement was numerically shorter with remdesivir than with placebo (18 vs. 23 days).

And finally, remdesivir’s manufacturer reported that 5- and 10-day courses of the drug were similarly efficacious for severe COVID-19. The results have not yet been published in a peer-reviewed journal.