Remdesivir trial posted online prematurely was ‘inconclusive,’ Gilead says
(CNN)Results from a study investigating Gilead Sciences’ antiviral medication remdesivir as a Covid-19 treatment were posted to the World Health Organization’s website “prematurely” on Thursday and showed “inconclusive” results, according to the biotechnology company.
“Today, information from the first clinical study evaluating the investigational antiviral remdesivir in patients with severe Covid-19 disease in China was prematurely posted on the World Health Organization website. This information has since been removed, as the study investigators did not provide permission for the publication of the results. Furthermore, we believe the post included inappropriate characterizations of the study,” said Dr. Merdad Parsey, chief medical officer of Gilead Sciences in a statement on Twitter.
“The study was terminated early due to low enrollment and, as a result, it was underpowered to enable statistically meaningful conclusions,” the tweet said. “As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease. We understand the available data have been submitted for peer-reviewed publication, which will provide more detailed information from this study in the near future.”
A screenshot of the study description posted to WHO’s website was published by STAT on Thursday. The description in the screenshot notes that the study, which involved 237 patients, found “remdesivir use was not associated with a difference in time to clinical improvement” and “in this study of hospitalized adult patients with severe Covid-19 that was terminated prematurely, remdesivir was not associated with clinical or virological benefits.”
CNN has reached out to WHO for comment.
Gilead’s statement on Thursday said there are multiple ongoing Phase III studies designed to help gather additional data needed to determine remdesivir’s potential as a Covid-19 treatment.
“These studies will help inform whom to treat, when to treat and how long to treat with remdesivir,” the statement said. “The studies are either fully enrolled for the primary analysis or on track to fully enroll in the near future.”
Remdesivir has been shown in some animal studies to treat coronaviruses similar to the novel coronavirus that causes Covid-19.
More than 864,400 cases of Covid-19 have been reported with at least 47,890 deaths as of Thursday, according to Johns Hopkins University.
Currently, there is no treatment for Covid-19 approved by the US Food and Drug Administration. While doctors are trying various treatments, it’s not yet known if they’ll work.
The FDA has said that 72 active trials are underway, with another 211 in the planning stages as of April 19.
Read more: https://www.cnn.com/2020/04/23/health/remdesivir-trial-gilead-premature/index.html