Gilead announced that a trial in China evaluating its investigational antiviral remdesivir for coronavirus disease 2019 (COVID-19) has been terminated early due to low enrollment and would therefore not provide statistically meaningful conclusions on the drug’s effectiveness.
The statement comes after study results were prematurely posted on the World Health Organization (WHO) website. The information has since been removed. According to the Company, data from this trial have been submitted for peer review and will be published in the near future.
“The results of this 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,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. However, according to Parsey, trends in the data did suggest a potential benefit.
Remdesivir, a nucleotide analog with broad spectrum antiviral activity, is currently being studied in multiple phase 3 trials in patients with moderate and severe COVID-19. “The studies are either fully enrolled for the primary analysis or on track to fully enroll in the near future,” said Parsey. Data from an open-label randomized controlled trial that is fully enrolled is expected to be available by the end of April; this trial is evaluating treatment outcomes with 5 or 10 days of remdesivir in patients with severe COVID-19 disease. Additionally, data from a trial evaluating patients with moderate disease is expected by the end of May.
Results from a randomized, double-blind, placebo-controlled trial sponsored by the National Institute of Allergy and Infectious Disease (NIAD) are also anticipated by the end of May.
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