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Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials

2020; American College of Physicians; Volume: 174; Issue: 2 Linguagem: Inglês

10.7326/m20-6169

1539-3704

Devan V. Mehrotra, Holly Janes, Thomas R. Fleming, Paula W. Annunziato, Kathleen M. Neuzil, Lindsay N. Carpp, David Benkeser, Elizabeth R. Brown, Marco Carone, Iksung Cho, Deborah Donnell, Michael P. Fay, Youyi Fong, Shu Han, Ian Hirsch, Ying Huang, Yunda Huang, Ollivier Hyrien, Michal Juraska, Alex Luedtke, Martha Nason, An Vandebosch, Haiyu Zhou, Myron S. Cohen, Lawrence Corey, Jonathan Hartzel, Dean Follmann, Peter B. Gilbert,

COVID-19 Clinical Research Studies

Several vaccine candidates to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or coronavirus disease 2019 (COVID-19) have entered or will soon enter large-scale, phase 3, placebo-controlled randomized clinical trials. To facilitate harmonized evaluation and comparison of the efficacy of these vaccines, a general set of clinical endpoints is proposed, along with considerations to guide the selection of the primary endpoints on the basis of clinical and statistical reasoning. The plausibility that vaccine protection against symptomatic COVID-19 could be accompanied by a shift toward more SARS-CoV-2 infections that are asymptomatic is highlighted, as well as the potential implications of such a shift.