Due to low enrollment, study was ‘underpowered to enable statistically meaningful conclusions’
FRIDAY, April 24, 2020 (HealthDay News) — Inconclusive findings from a study investigating the antiviral drug remdesivir as a treatment for COVID-19 were posted to the World Health Organization website “prematurely,” drug maker Gilead Sciences said Thursday.
The study that included 237 patients and was halted early for its small size was posted Thursday and has since been removed, CNN reported. A screenshot of the posting published by STAT on Thursday said “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.”
“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,” Merdad Parsey, M.D., Ph.D., Gilead chief medical officer, said in a statement on Twitter, CNN reported. “The study was terminated early due to low enrollment and, as a result, it was underpowered to enable statistically meaningful conclusions. 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.”
The company said there are a number of ongoing phase 3 studies examining potential of remdesivir as a COVID-19 treatment, CNN reported.
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