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Remdesivir Fails in Severe COVID-19 Trial in China

— No clinical benefit between groups in randomized trial, mistakenly released data show

MedpageToday
Remdesivir on an illustrated rocket which has crashed into the ground

Investigational agent remdesivir, an antiviral being evaluated for treatment of COVID-19, showed no difference in time to clinical improvement or mortality at 28 days among hospitalized patients with severe infection versus a control group, a draft abstract accidentally published by the World Health Organization (WHO) showed.

In , the randomized trial, which was terminated prematurely due to poor accrual, found no difference between groups in time to clinical improvement compared with the control group (HR 1.23, 95% CI 0.87-1.75) or mortality at 28 days (13.9% vs 12.8%, respectively).

There was also no virological benefit to the drug, with no difference in "time to SARS-CoV-2 PCR," the abstract said.

WHO's website went so far as to characterize the outcome as "negative."

Moreover, while about two-thirds of patients reported adverse events in both groups, remdesivir was stopped early in 12% of patients due to adverse events compared with 5.1% of control patients.

The trial was comprised of 237 hospitalized patients with severe COVID-19 infection, 158 who received the drug and 79 who did not.

The Financial Times also reported on the data, and cited a statement from the organization:

"In response to WHO asking for information and studies to be shared early, a draft document was provided by the authors to WHO and inadvertently posted on the website and taken down as soon as the mistake was noticed."

on a separate website, the Financial Times noted. The data have since been removed.

Retrospective data published in the New England Journal of Medicine, as well as , hinted at potentially positive results from the drug in patients with severe COVID-19 infection.

Manufacturer Gilead Sciences said the WHO data included "inappropriate [characterizations] of the study," adding it was "underpowered to enable statistically meaningful conclusions," according to the Financial Times report.