Remdesivir significantly cuts hospitalization, death risk in moderate to severe COVID-19 patients: Study
USA: Researchers have found in a randomized, double-blind, placebo-controlled trial involving nonhospitalized patients with COVID-19 that a 3-day course of remdesivir resulted in an 87% lower risk of hospitalization or death than a placebo. The study has been published in the New England Journal of Medicine.
Remdesivir is a direct-acting nucleotide prodrug inhibitor of the SARS-CoV-2 RNA-dependent RNA polymerase and it improves clinical outcomes in patients hospitalized with moderate-to-severe Covid-19 infection. Can remdesivir be used in symptomatic, nonhospitalized patients with Covid-19 who are at high risk for disease progression prevent hospitalization is uncertain. To find the same, Robert L. Gottlieb, and the team conducted this study.
The researchers engaged Covid-19 patients who had symptom onset within the previous 7 days and who had at least one risk factor for disease progression (age ≥60 years, obesity, or certain coexisting medical conditions) in the study. They were randomly assigned to receive intravenous remdesivir (200 mg on day 1 and 100 mg on days 2 and 3) or a placebo.
In the study, a total of 562 patients who underwent randomization and received at least one dose of remdesivir or placebo were included in the analyses: 279 patients in the remdesivir group and 283 in the placebo group. The mean age was 50 years, 47.9% of the patients were women, and 41.8% were Hispanic or Latinx. The most common coexisting conditions were diabetes mellitus (61.6%), obesity (55.2%), and hypertension (47.7%).
The primary efficacy endpoint was a composite of Covid-19–related hospitalization or death from any cause by day 28. The primary safety endpoint was any adverse event. A secondary endpoint was a composite of a Covid-19–related medically attended visit or death from any cause by day 28.
It was found that Covid-19–related hospitalization or death from any cause occurred in 2 patients (0.7%) in the remdesivir group and in 15 (5.3%) in the placebo group. Further, a total of 4 of 246 patients (1.6%) in the remdesivir group and 21 of 252 (8.3%) in the placebo group had a Covid-19–related medically attended a visit by day 28. No patients had died by day 28. Adverse events occurred in 42.3% of the patients in the remdesivir group and in 46.3% of those in the placebo group.
The researchers concluded that among nonhospitalized patients who were at high risk for Covid-19 progression, a 3-day course of remdesivir had an acceptable safety profile and resulted in an 87% lower risk of hospitalization or death than placebo.
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