Remdesivir vs. Standard Care in Patients With Moderate COVID-19 ( Remdesivir for Moderate COVID-19 )
Contribution To Literature:
This trial showed that a 5-day course of remdesivir was superior to standard therapy at improving clinical status.
The goal of the trial was to evaluate remdesivir compared with standard therapy among patients with moderate coronavirus disease 2019 (COVID-19) infection. Previous evaluation found that remdesivir was beneficial treatment for patients with severe COVID-19 infection.
Patients who met enrollment criteria were randomized to remdesivir for 10 days (n = 197) versus remdesivir for 5 days (n = 199) versus standard therapy (n = 200). Remdesivir was given intravenously 200 mg on day 1, then 100 mg daily.
- Total number of enrollees: 596
- Duration of follow-up: 14 days
- Mean patient age: 57 years
- Percentage female: 39%
- Percentage with diabetes: 40%
- COVID-19 infection
- Moderate pneumonia (pulmonary infiltrates and room air oxygen saturation >94%)
- Alanine aminotransferase or aspartate aminotransferase >5 times the upper limit of normal
- Creatinine clearance <50 ml/min
Other salient features/characteristics:
The primary outcome was a 7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation; 3, hospitalized, requiring noninvasive ventilation or use of high-flow oxygen devices; 4, hospitalized, requiring low-flow supplemental oxygen; 5, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related or not to COVID-19); 6, hospitalized, not requiring supplemental oxygen or ongoing medical care; and 7, not hospitalized.
The primary outcome, favorable clinical status distribution on day 11, was increased in the remdesivir 5-day group versus the standard care group (odds ratio 1.65, 95% confidence interval p < 0.001). Favorable clinical status distribution on day 11 was similar in the remdesivir 10-day group versus the standard care group (p = 0.18).
- Discontinuation of study drug because of an adverse event: 4% in the 10-day remdesivir group versus 2% in the 5-day remdesivir group (p = nonsignificant)
Among patients infected with COVID-19 and with moderate pneumonia, a 5-day course of remdesivir was associated with improved clinical status compared with standard therapy. A 10-day course or remdesivir was not associated with a statistical difference compared with standard therapy. The clinical significance of the finding in the 5-day remdesivir group is unknown. The open-label design of the trial could have led to study bias.
Spinner CD, Gottlieb RL, Criner GJ, et al. Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial. JAMA 2020;Aug 21:[Epub ahead of print].
American College of Cardiology