Primary endpoint: Time to clinical improvement up to day 28
80% power | One-sided type I error of 2.5% (assumption that hazard ratio (HR) comparing remdesivir to placebo is 1.4)
Assuming 10% drop out, 453 patients required (151 on placebo and 302 on remdesivir)
237 patients | 158 to remdesivir and 79 to placebo
Primary endpoint: There was no difference in time to clinical improvement between the 2 groups
Median days to improvement
Remdesivir: 21.0 days (IQR 13.0 – 28.0)
Placebo: 23.0 days (IQR 15.0–28.0)
HR 1.23 (95% CI, 0.87–1.75)
Those on remdesivir improve faster if symptom duration was ≤10 days, but this finding was not significant (HR 1.52 [0.95–2.43])
There were no differences noted for the following
Time to clearance of virus
Note: Trial stopped early because of drop in cases in the region (lack of patients meeting eligibility) and also concerns related to adverse medication events
…higher proportion of remdesivir recipients than placebo recipients had dosing prematurely stopped by the investigators because of adverse events including gastrointestinal symptoms (anorexia, nausea, and vomiting), aminotransferase or bilirubin increases, and worsened cardiopulmonary status.
This RCT did not demonstrate benefit for the use of remdesivir although there was a trend to reduced time to clinical improvement in those receiving the medication earlier in the course of their illness
Authors acknowledge significant limitations, especially the fact that the trial was stopped early and therefore underpowered
An accompanying editorial makes the point that the study made valuable safety and viral clearance information available and concludes that
An absence of statistical significance in an underpowered trial means that the findings are inconclusive
The particular challenges of delivering pandemic trials underline the importance of data sharing, allowing rapid curation of relevant datasets for individual patient data meta-analyses
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