Re-analysis of Molnupiravir Trials, Phase II/III

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSitePREPRINT

November 28, 2021

by Leo Goldstein

Contact [email protected]

Can be cited as: Goldstein L., Re-analysis of Molnupiravir Trials, Phase II/III;, PREPRINT, [link], 2021


This is a re-analysis of the data from Molnupiravir trials, presented by the FDA.

The trials’ sponsor modified the pre-registered protocol, so the results will appear more beneficial than they are. To this end, results from patients recruited by August 5 were reported as a separate trial – here referred to as Trial 1. Thus, the data from patients recruited after August 5 should also be presented as a separate trial – here referred to as Trial 2.

In this second trial, the Molnupiravir arm had 32.5% higher relative risk of hospitalization or death compared to the placebo arm.

Both trials show that starting Molnupiravir treatment later (more then 3 days after symptom onset) is associated with better outcomes than starting the treatment earlier (less then 3 days from symptom onset). This is consistent with the hypothesis that Molnupiravir harms th...

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