Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 32821939 · doi:10.1001/jama.2020.16349
What was done
An open-label, randomized clinical trial at 105 hospitals across the United States, Europe, and Asia evaluated hospitalized patients with moderate COVID-19 pneumonia (infiltrates on imaging, room-air SpO2 >94%). Patients were randomized 1:1:1 to a 5-day course of intravenous remdesivir (n=199), a 10-day course of intravenous remdesivir (n=197), or standard care alone (n=200). The primary outcome was clinical status at day 11 measured on a 7-point ordinal scale ranging from death to hospital discharge.
What was found
Among 596 randomized patients (584 received study treatment, median age 57 years), the 5-day remdesivir group had significantly higher odds of improved clinical status on day 11 compared with standard care (odds ratio 1.65; 95% CI, 1.09-2.48; P = .02). The 10-day remdesivir group showed no statistically significant difference versus standard care (P = .18). By day 28, mortality occurred in 1% (2/199) of the 5-day group, 2% (3/197) of the 10-day group, and 2% (4/200) of the standard care group. Adverse events more common with remdesivir included nausea (10% vs 3%), hypokalemia (6% vs 2%), and headache (5% vs 3%).
Why it matters
This trial established that remdesivir yields at best a modest clinical benefit in patients hospitalized with moderate COVID-19 not requiring supplemental oxygen, with a shorter 5-day regimen outperforming a 10-day course.
Limits
The trial used an open-label design without a placebo control, introducing potential performance and discharge decision biases. There was no dose-response relationship, as the 10-day arm failed to show efficacy, leaving the true clinical significance of the 5-day benefit uncertain.
Cited by
- supports Brigham and Women's Hospital received approval to conduct a clinical trial of remdesivir in 600 patients.