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The National Institutes of Health sponsored the Adaptive Covid-19 Treatment Trial (ACTT-1), a placebo-controlled, randomized trial of remdesivir for treatment of COVID-19. Unpublished results were announced previously, but now the eagerly awaited details, including important subgroup analyses, have been published. Patients hospitalized with COVID-19 and evidence of lower respiratory tract involvement were enrolled between February 21 and April 19, 2020. Participants were randomized 1:1 to receive intravenous remdesivir or placebo for 10 days or until discharge. Preliminary results from 1059 participants are now reported. (Additional follow-up is ongoing.)
Participants in the remdesivir group had a shorter time to recovery than those in the placebo group (11 vs. 15 days; rate ratio for recovery, 1.32). The benefit was most apparent in participants who were on supplemental oxygen but not intubated (rate ratio for recovery, 1.47). Among those on mechanical ventilation or extracorporeal membrane oxygenation at time of enrollment, time to recovery was not different between the remdesivir and placebo groups (rate ratio for recovery, 0.95), but the confidence interval was wide. Mortality estimates by day 14 were nonsignificantly lower in the remdesivir group than in the placebo group (7.1% vs. 11.9%). Rates of kidney and liver adverse events were similar in the remdesivir and placebo groups.
Beigel JH et al. Remdesivir for the treatment of Covid-19— Preliminary report. N Engl J Med 2020 May 22; [e-pub]. (https://doi.org/10.1056/NEJMoa2007764)
Comment
This large placebo-controlled trial supports the use of remdesivir in hospitalized patients with severe COVID-19. The benefit in improving time to recovery is most evident in those who are on supplemental oxygen but not intubated. Possibly, people who are mechanically ventilated also would derive benefit, but these preliminary results do not show an impact, perhaps because follow-up was too short. (Mechanically ventilated patients take longer to recover than less ill patients.) As for many infectious diseases, starting antiviral therapy before illness has progressed too far may be most likely to help, but more data and longer follow-up on critically ill patients are needed. Nevertheless, this trial is a landmark. For HIV, it took years to show a clinical effect of the first antiviral drug; for COVID-19, it took months. Clearly, much more must be done to improve outcomes for people with severe COVID-19 — morbidity and mortality are still too high — but this first “ACTT” is a good start.