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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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>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 \u2265 0.72, moderate 0.49 &amp;lt; R2 &amp;lt; 0.72, and weak \u2264 0.49. We estimated R2 for various viral load outcomes at days 3, 5, and 7, including change-from-baseline, slope, average area under the curve minus baseline (AAUCMB), and a change of at least 0.5\u2005log10 copies\/mL from baseline to day 3.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>R 2 was numerically highest for the change-from-baseline to day 3 (0.53; 95% confidence interval [CI], .26\u2013.79), slightly lower for change-from-baseline to day 5 (0.49; 95% CI, .24\u2013.75) and numerically lower for change-from-baseline to day 7 (0.40; 95% CI, .15\u2013.65). All were statistically significant.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Discussion<\/jats:title>\n                  <jats:p>Our study is the first to use IPD, allowing us to evaluate viral load collected on various study days as a surrogate to clinical outcomes. Change in log10(viral load) from baseline to day 3 or day 5 are moderate surrogates for 28-day hospitalization\/death and suitable primary end points in phase 2 clinical trials and are preferred over change-from-baseline to day 7. Slope and AAUCMB require more calculation but did not improve prediction so are not recommended.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/infdis\/jiaf282","type":"journal-article","created":{"date-parts":[[2025,5,31]],"date-time":"2025-05-31T07:42:01Z","timestamp":1748677321000},"page":"60-68","source":"Crossref","is-referenced-by-count":4,"title":["The Choice of Viral Load End Point in Early Phase Trials of COVID-19 Treatments Aiming to Reduce 28-Day Hospitalization and\/or Death"],"prefix":"10.1093","volume":"232","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2810-478X","authenticated-orcid":false,"given":"Allyson","family":"Mateja","sequence":"first","affiliation":[{"name":"Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research , Frederick, Maryland ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Chu","sequence":"additional","affiliation":[{"name":"Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research , Frederick, Maryland ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2769-4957","authenticated-orcid":false,"given":"Thomas A","family":"Murray","sequence":"additional","affiliation":[{"name":"Division of Biostatistics and Health Data Science, School of Public Health, University of Minnesota , Minneapolis, Minnesota ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carolyn T","family":"Bramante","sequence":"additional","affiliation":[{"name":"General Internal Medicine, Department of Medicine, University of Minnesota Medical School , Minneapolis, Maryland ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5601-9112","authenticated-orcid":false,"given":"Carlee","family":"Moser","sequence":"additional","affiliation":[{"name":"Center for Biostatistics in AIDS Research, Harvard T.H. 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