Gilead’s Remdesivir Trial Fails to Show Improvement in Patients with Severe COVID-19

Gilead Sciences (Foster City, CA, USA) has issued a statement saying that information from the first clinical study evaluating the investigational antiviral remdesivir in patients with severe COVID-19 disease in China had been prematurely posted on the World Health Organization website. According to Gilead, the information has since been removed, as the study investigators did not provide permission for the publication of the results. Additionally, the company believes the post included inappropriate characterizations of the study. Gilead has stated that the study was terminated early due to low enrollment, thus making it underpowered to enable statistically meaningful conclusions.

Although the study results are inconclusive, the company believes that trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease. According to Gilead, the results of the trial in China, along with those of the compassionate use cohort of more critically ill patients published on April 10, add to a growing but still inconclusive body of evidence for remdesivir. Remdesivir is an unapproved investigational product, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet known. There are multiple ongoing Phase 3 studies that are designed to provide the additional data needed to determine the potential for remdesivir as a treatment for COVID-19.

Gilead expects to share the results at the end of April from its open-label study of remdesivir in patients with severe COVID-19 disease. The randomized clinical trial is fully enrolled and will compare treatment outcomes and safety following five or 10 days of remdesivir treatment. The company expects data at the end of May from its open-label study in patients with moderate disease that is studying five or 10 days of remdesivir versus standard of care. Gilead also anticipate data at the end of May from NIAID’s double-blind, placebo-controlled study of remdesivir in patients across a range of disease severity.

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