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.