학술논문
Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19
Document Type
article
Author
Chew, Kara W; Moser, Carlee; Daar, Eric S; Wohl, David A; Li, Jonathan Z; Coombs, Robert W; Ritz, Justin; Giganti, Mark; Javan, Arzhang Cyrus; Li, Yijia; Choudhary, Manish C; Deo, Rinki; Malvestutto, Carlos; Klekotka, Paul; Price, Karen; Nirula, Ajay; Fischer, William; Bala, Veenu; Ribeiro, Ruy M; Perelson, Alan S; Fletcher, Courtney V; Eron, Joseph J; Currier, Judith S; Hughes, Michael D; Smith, Davey M
Source
Nature Communications. 13(1)
Subject
Language
Abstract
Anti-SARS-CoV-2 monoclonal antibodies are mainstay COVID-19 therapeutics. Safety, antiviral, and clinical efficacy of bamlanivimab were evaluated in the randomized controlled trial ACTIV-2/A5401. Non-hospitalized adults were randomized 1:1 within 10 days of COVID-19 symptoms to bamlanivimab or blinded-placebo in two dose-cohorts (7000 mg, n = 94; 700 mg, n = 223). No differences in bamlanivimab vs placebo were observed in the primary outcomes: proportion with undetectable nasopharyngeal SARS-CoV-2 RNA at days 3, 7, 14, 21, and 28 (risk ratio = 0.82-1.05 for 7000 mg [p(overall) = 0.88] and 0.81-1.21 for 700 mg [p(overall) = 0.49]), time to symptom improvement (median 21 vs 18.5 days [p = 0.97], 7000 mg; 24 vs 20.5 days [p = 0.08], 700 mg), or grade 3+ adverse events. However, bamlanivimab was associated with lower day 3 nasopharyngeal viral levels and faster reductions in inflammatory markers and viral decay by modeling. This study provides evidence of faster reductions in nasopharyngeal SARS-CoV-2 RNA levels but not shorter symptom durations in non-hospitalized adults with early variants of SARS-CoV-2.