The Choice of Viral Load End Point in Early Phase Trials of COVID-19 Treatments Aiming to Reduce 28-Day Hospitalization and/or Death.

ABSTRACT:

Background

Virologic end points are used in phase 2 trials for COVID-19 therapeutics, but they have not been established as surrogates for clinical end points. No meta-analysis using individual participant data (IPD) has been undertaken to identify viral load outcomes for which treatment effects are best associated with effects on hospitalization/death.

Methods

This meta-analysis combined IPD from 23 COVID-19 treatment versus control comparisons to calculate R2, a surrogacy measure quantifying the relationship between the treatment effect on 28-day hospitalization/death and the treatment effect on the surrogate. R2 ranges from 0 to 1, with a strong relationship ≥ 0.72, moderate 0.49 < R2 < 0.72, and weak ≤ 0.49. We estimated R2 for various viral load outcomes at days 3, 5, a

SUBMITTER: Mateja A 

PROVIDER: S-EPMC12308656 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature