N Engl J Med 2021 Jul 14. Epub 2021 Jul 14.
From Massachusetts General Hospital and Harvard Medical School, Boston (M. Dougan); Eli Lilly (A.N., A.C.A., J.V.N., K.L.C., M. Durante, G.O., A.E.S., T.R.H., P.J.E., R.E.H., N.L.K., J.S., D.R.P., M.C.D., P. Klekotka, L.S., D.M.S.), and Franciscan Health (I.S.) - both in Indianapolis; Valley Clinical Trials-Northridge, Northridge (M.A.), the Department of Medicine, Women's Guild Lung Institute, Cedars-Sinai Medical Center, Los Angeles (P.C.), and Long Beach Clinical Trials, Long Beach (B.H.) - all in California; the Las Vegas Medical Research Center, Las Vegas (B.M.); Baylor University Medical Center and Baylor Scott and White Research Institute, Dallas (R.L.G.), and Gadolin Research, Beaumont (R.P.) - both in Texas; NOLA Research Works, New Orleans (C.H.), and Clinical Trials of Southwest Louisiana, Lake Charles (J.M.) - both in Louisiana; Vitalink Research, Union, SC (J.B.); Eastside Research Associates, Redmond, WA (C.C.); Monroe Biomedical Research, Monroe, NC (A.I.); Cook County Health, Chicago (G.H.); Indago Research and Health Center, Hialeah, FL (J.C.); and Georgetown University, Washington, DC (P. Kumar).
Background: Patients with underlying medical conditions are at increased risk for severe coronavirus disease 2019 (Covid-19). Whereas vaccine-derived immunity develops over time, neutralizing monoclonal-antibody treatment provides immediate, passive immunity and may limit disease progression and complications.
Methods: In this phase 3 trial, we randomly assigned, in a 1:1 ratio, a cohort of ambulatory patients with mild or moderate Covid-19 who were at high risk for progression to severe disease to receive a single intravenous infusion of either a neutralizing monoclonal-antibody combination agent (2800 mg of bamlanivimab and 2800 mg of etesevimab, administered together) or placebo within 3 days after a laboratory diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Read More