Randomized Controlled Study Finds Remdesivir “Not associated with statistically significant clinical benefits”

The results of a new randomized controlled study about remdesivir to treat COVID-19 have just been released.

The study was carried out on 237 sick patients aged 18 or over, with ≤12 days since illness onset.

The study is titled: “A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir in Hospitalized Adult Patients With Severe COVID-19”

The protocols details can be found here:
https://clinicaltrials.gov/ct2/show/NCT04257656

Here are the findings, as published in The Lancet.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext

Findings

Between Feb 6, 2020, and March 12, 2020, 237 patients were enrolled and randomly assigned to a treatment group (158 to remdesivir and 79 to placebo); one patient in the placebo group who withdrew after randomisation was not included in the ITT population. Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23 [95% CI 0·87–1·75]). Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95–2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early.

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Interpretation

In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext

In a related development, remsedivir manufacturer Gilead announced another study, that “demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course.”

Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.

https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-announces-results-from-phase-3-trial-of-investigational-antiviral-remdesivir-in-patients-with-severe-covid-19

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