Remdesivir for the Treatment of Covid-19 - Final Report.
Level 2 - randomized trial
Individual double-blind randomized placebo-controlled trial
PubMed 32445440 · doi:10.1056/NEJMoa2007764
What was done
Adults hospitalized with Covid-19 and evidence of lower respiratory tract infection were enrolled in a double-blind, randomized, placebo-controlled trial (ACTT-1). Participants were randomly assigned to receive either intravenous remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 days) or placebo for up to 10 days. The primary outcome was time to recovery, defined as hospital discharge or hospitalization solely for infection-control purposes.
What was found
A total of 1062 patients underwent randomization (541 to remdesivir, 521 to placebo). Median recovery time was 10 days (95% CI, 9 to 11) with remdesivir compared with 15 days (95% CI, 13 to 18) with placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001). Patients receiving remdesivir had higher odds of clinical improvement at day 15 on an 8-category ordinal scale (OR, 1.5; 95% CI, 1.2 to 1.9). Kaplan-Meier mortality estimates were 6.7% vs 11.9% at day 15 and 11.4% vs 15.2% at day 29 for remdesivir vs placebo (HR, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events occurred in 131 of 532 patients (24.6%) receiving remdesivir and 163 of 516 patients (31.6%) receiving placebo.
Why it matters
This trial provides clear randomized evidence that remdesivir accelerates recovery in hospitalized adults with Covid-19 and lower respiratory tract infection.
Limits
The study was confined to hospitalized adults with lower respiratory tract disease, so results cannot be generalized to outpatients or milder infection. The reduction in 29-day mortality did not achieve statistical significance, and follow-up was limited to 29 days.
Cited by
- supports Remdesivir demonstrated greater efficacy early in the course of COVID-19 compared to late-stage disease in patients on mechanical ventilators.