Remdesivir Shows 68% Clinical Improvement in Severe COVID-19 Patients: Compassionate Use Data Published in NEJM

On June 11, The New England Journal of Medicine published the results of compassionate use of remdesivir in patients with severe COVID-19. The results showed that clinical improvement was observed in 36 out of 53 patients (68%) in the cohort who were hospitalized for severe COVID-19 and received remdesivir under compassionate use. The assessment of efficacy awaits the results of ongoing randomized, placebo-controlled trials of remdesivir (funded by Gilead Sciences, Inc.).

The paper indicates that remdesivir was provided to hospitalized patients receiving treatment for COVID-19 (caused by SARS-CoV-2 infection) under compassionate use. The patients were confirmed cases of SARS-CoV-2 infection with an oxygen saturation of ≤94% while breathing ambient air or requiring oxygen support. Patients received remdesivir treatment for 10 days, with a regimen of 200 mg administered intravenously on Day 1, followed by 100 mg daily for the subsequent 9 days. The study paper notes that the data from the patient cohort are based on those who received remdesivir between January 25, 2020, and March 7, 2020, and had at least one day of follow-up clinical data.

The results showed that 61 patients received at least one dose of remdesivir, among whom data from 8 patients were not analyzable (7 patients lacked post-treatment data, and 1 patient had a medication error). Data from 53 patients were available for analysis, including 22 patients from the United States, 22 from Europe or Canada, and 9 from Japan. At baseline, 30 patients (57%) were receiving mechanical ventilation, and 4 (8%) were receiving extracorporeal membrane oxygenation (ECMO). The median follow-up period was 18 days, during which 36 patients (68%) showed improvement in their oxygen support status; among the 30 patients supported by mechanical ventilation, 17 (57%) were extubated. A total of 25 patients (47%) were discharged, and 7 patients (13%) died; among patients who received invasive ventilation, the mortality rate was 18% (6 deaths out of 34 patients), whereas the mortality rate among those who did not receive invasive ventilation was 5% (1 death out of 19 patients).

Thus, it was concluded that clinical benefit was observed in 36 (68%) of the 53 patients hospitalized with severe COVID-19 who received remdesivir under compassionate use. The assessment of efficacy awaits the results of ongoing randomized, placebo-controlled trials of remdesivir (funded by Gilead Sciences, Inc.).

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