A much anticipated clinical trial for remdesivir, an antiviral medicine from Gilead Sciences, showed the drug failed to improve the condition of coronavirus patients, according to preliminary study results accidentally posted online.
The drug’s trial, which took place in China, indicated that remdesivir did not improve the symptoms of patients or diminish the virus’s presence in the bloodstream, according to the early results mistakenly published by the World Health Organization.
“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,” WHO spokesperson Tarik Jasarevic said. “The manuscript is undergoing peer review and we are waiting for a final version before WHO comments.”
The drug was “not associated with a difference in time to clinical improvement” according to the summary of the study.
“In this study of hospitalized adult patients with severe COVID-19 that was terminated prematurely, remdesivir was not associated with clinical or virological benefits,” the summary reads.
After a month, 13.9 percent of the patients receiving remdesivir infusions had died, while only 12.8 percent of the control patients had died, a difference small enough that it is not statistically significant.
The study, which involved daily infusions of remdesivir for 10 days, attempted to demonstrate that patients receiving remdesivir improved more within 28 days than the patients who did not receive it.
The California-based biopharmaceutical company has challenged the negative characterization of the study’s preliminary data and said there is still room for hope in the benefits of remdesivir for coronavirus patients.
“The post included inappropriate characterizations of the study,” Gilead representative Amy Flood said. The study, she argued, did not observe enough patients and so does not “enable statistically meaningful conclusions.”
Gilead’s study originally planned to observe 453 patients but ended up with only 158 patients receiving remdesivir and 79 control patients.
“Trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease,” Flood insisted.