Safety monitoring of molnupiravir for treatment of mild to moderate COVID-19 infection in low and middle-income countries using cohort event monitoring: a WHO study

Overview

This is a master protocol, which was approved by the WHO Ethics Review Committee (ERC) on 09.03.2022 (protocol ID; CERC.0155. It will be used by study sites who will submit a protocol to their national ERC. The only country-specific changes that should be made will be those to facilitate translation into the local language, address the specific concerns of the local ERC, and to add the names of the national principal investigators (PIs), members of the local study teams and the identity of the study sites. Amended site-specific protocols developed for implementation in countries based on this WHO master protocol must be approved by the WHO ERC prior to implementation.