Lancet Lifts Embargo to Sound Cautionary Note about Remdesivir

The move came in response to contradictory news from unpublished studies. (Updated)

Joshua Niforatos, MD, MTSJeremy Samuel Faust, MD, MS, MA
Research Section Editor

On a day when President Trump and Dr. Anthony Fauci, the government's leading infectious disease scientist, hailed preliminary data from an NIH trial suggesting that remdesivir could shorten recovery times for people with covid-19, The Lancet accelerated the publication of a randomized clinical trial that found no statistically significant clinical benefit for patients with severe covid-19 receiving remdesivir.

The Lancet told Brief19 that "following today's release of the topline findings from other studies on remdesivir, we considered it important for the full data in our paper to be made available immediately to ensure any public discussion on the effectiveness of the drug is based on the best available evidence. We therefore decided to lift the embargo ahead of the planned publication time."

The lifted embargo was known to journalists earlier today, but Brief19 learned that the decision had specifically been made in response to rumors about two other studies of the drug that presented far more favorable evidence.

The study in The Lancet, entitled "Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial," assessed patients with laboratory-confirmed SARS-CoV-2 infection with pneumonia who required supplemental oxygenation. Patients in this study, conducted in China, received either remdesivir or a placebo infusion, and all patients were allowed use of other medications, such as lopinavir–ritonavir, interferons, and corticosteroids. The researchers collected data on clinical improvement up to 28 days. Favorable outcomes were considered to be improvement in clinical status or being released from the hospital.

A total of 237 patients were enrolled and randomized in this study. The study found that, among patients with symptom duration of 10 days or less, those receiving remdesivir had a numerically faster time to clinical improvement than those receiving a placebo, but the difference was not statistically significant. The study was stopped early because as of March 12, there were not enough patients in Wuhan who qualified based on the inclusion criteria.

The results of two other Gilead-funded studies, cited by President Trump and Dr. Fauci,suggest that remdesivir may improve clinical outcomes in patients with covid-19. Those studies remain unpublished, however, and the data cannot yet be scrutinized. However, the trial designs that are already public indicate that neither study is likely to have game-changing findings.  Gilead's stock rose six percent today.

(Earlier version here)