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

Abstract

The following review has been prepared in collaboration with members of the MRC-NIHR Trials Methodology Research Partnership. The reviewers named above, and other, unnamed discussants of the paper, are all qualified statisticians with  experience in clinical trials. Our objective is to provide a rapid review of publications, preprints and protocols from clinical trials of  COVID-19 treatments, independent of journal specific review processes. We aim to provide timely, constructive, focused, clear  advice aimed at improving both the research outputs under review, as well as future studies. Given our collective expertise (clinical  trial statistics) our reviews focus on the designs of the trials and other statistical content (methods, presentation and accuracy of  results, inferences). This review reflects the expert opinions of the named authors, and does not imply endorsement by the MRC-NIHR Trials Methodology Research Partnership, its wider membership, or any other organization. Here we review Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial by Wang et al, which was published in The Lancet, April 29, 2020. Overall, this was a well-conducted, well-reported trial, which was faithful to a pre-registered, openly available study protocol. Our comments on the paper, detailed below, are all minor in nature. The trial ended early, roughly half-way to its planned sample size, once successful infection control efforts in the region made it difficult to recruit new patients. It is perhaps not surprising then that the study did not demonstrate any substantial effects of remdesivir, though the authors correctly noted that the study was too small to rule out potentially important effects. Regardless, it will be important for investigators and decision makers to take data from this study into account as our understanding of COVID-19 treatment grows.