Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial

RCT in 237 adult patients admitted to hospital for severe COVID-19 in Hubei, China found no statistically significant clinical benefits. The numerical reduction in time to clinical improvement in those treated earlier with remdesivir requires confirmation in larger studies.

SPS commentary:

A commentary notes this study was stopped early after 237 of the intended 453 patients were enrolled, because by March 12 there were no further patients meeting eligibility criteria admitted in Wuhan. The study closed on March 29, having begun on Feb 6. Therefore stopping early led to an underpowered trial, which taken alone, gives inconclusive findings. It suggests the study has not shown a statistically significant finding confirming a remdesivir treatment benefit of at least the minimally clinically important difference, nor has it ruled such a benefit out. It notes the study sought a treatment effect of hazard ratio (HR) 1.40, translating to reducing median time to clinical improvement to 15 days (remdesivir) versus 21 days (placebo); the observed HR of 1.23 suggests that a benefit, if it exists, might be smaller than anticipated. As this study is the first randomised trial of intravenous remdesivir in patients with severe COVID-19, it is difficult to know what the minimally clinically important difference is; more data are needed and this may be addressed later on as lists five randomised trials of remdesivir recruiting globally, with one in severe COVID-19 from Gilead, with a target of 6000 participants.


The Lancet

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