Chinese researchers have scrapped a study testing Gilead Sciences' remdesivir in patients with mild-to-moderate COVID-19, saying "the epidemic…has been controlled well at present, no eligible patients can be recruited," according to an update posted Wednesday on the ClinicalTrials.gov website. The move comes days after a clinical trial of remdesivir targeting severely ill COVID-19 patients in China was halted two months into the study due to "stalled enrollment."
The latest trial was investigating remdesivir in an estimated 308 adults hospitalised in China with mild-to-moderate COVID-19. Participants were randomised to receive either Gilead's experimental antiviral drug or placebo, with the study scheduled to be completed on April 27. The trial was assessing time to clinical recovery as a primary outcome measure to a time frame up to 28 days, while secondary goals included all-cause mortality and frequency of respiratory progression, as well as frequency of the need for supplemental oxygen, non-invasive ventilation or mechanical ventilation.
Gilead is running its own Phase III studies of remdesivir in patients with moderate-to-severe symptoms of COVID-19, and expects to have results of the severe study in late April, while results for the moderate trial are due in May.
Meanwhile, early data from a cohort analysis released late last week found that remdesivir, which was provided on a compassionate-use basis, improved clinical outcomes in 68% of 53 hospitalised patients with COVID-19 in nine countries (for related analysis, see ViewPoints: Any data is good data for remdesivir). Some analysts suggested the findings were promising, but cautioned that it was difficult to draw firm conclusions given the small sample size.
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