Gilead’s Remdesivir Accelerates Recovery from Advanced COVID-19 in NIH Clinical Trial

Preliminary data analysis from a randomized, controlled trial has found that hospitalized patients with advanced COVID-19 and lung involvement who received Gilead Sciences’ (Foster City, CA, USA) remdesivir recovered faster than similar patients who received placebo.

The trial (known as the Adaptive COVID-19 Treatment Trial, or ACTT), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is the first clinical trial launched in the US to evaluate an experimental treatment for COVID-19.

Remdesivir, developed by Gilead, is an investigational broad-spectrum antiviral treatment administered via daily infusion for 10 days. It has shown promise in animal models for treating SARS-CoV-2 infection and has been examined in various clinical trials.

An interim analysis of data from the ACTT trial has found that remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials. Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo (p<0.001). Specifically, the median time to recovery was 11 days for patients treated with remdesivir as compared with 15 days for those who received placebo. The results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059).

NIAID will provide detailed information at an upcoming briefing, while Gilead will share additional remdesivir data from the company’s open-label Phase 3 SIMPLE trial in patients with severe COVID-19 disease shortly. The study will provide information on whether a shorter, 5-day duration of therapy may have similar efficacy and safety as the 10-day treatment course evaluated in the NIAID trial and other ongoing trials. Gilead expects data at the end of May from the second SIMPLE study evaluating the 5- and 10-day dosing durations of remdesivir in patients with moderate COVID-19 disease.

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