Accurate Measurement of Viral Clearance in Early-Phase Antiviral Studies in Coronavirus Disease 2019

Mateja et al [1] report a rigorous individual patient data meta-analysis from nine large (N= 268 to 1939) RCTs conducted early in the COVID-19 pandemic (2020 to beginning 2022).They examined the relationship between outcomes (hospitalisation and/or death) and viral clearance.Their conclusions are generally consistent with previous meta-analyses based on summary results [2-4], i.e. that acceleration of SARS-CoV-2 clearance is a moderate surrogate for clinical benefit in COVID-19, and thus a "suitable endpoint for phase 2 studies".This is important as there is no agreement on how best to use clinical or laboratory surrogates in phase 2 clinical studies of acute respiratory virus infection treatments and there is uncertainty how antiviral drugs should be assessed in preparation for the next pandemic.