Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19
Kara W Chew, Carlee Moser, Eric S Daar, David A Wohl, Jonathan Z Li, Robert W Coombs, Justin Ritz, Mark Giganti, Arzhang Cyrus Javan, Yijia Li, Manish C Choudhary, Rinki Deo, Carlos Malvestutto, Paul Klekotka, Karen Price, Ajay Nirula, William Fischer, Veenu Bala, Ruy M Ribeiro, Alan S Perelson, Courtney V Fletcher, Joseph J Eron, Judith S Currier, Michael D Hughes, Davey M Smith
Nature Communications, doi:10.1038/s41467-022-32551-2
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. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Coronavirus disease 2019 (COVID-19), continues to exert an enormous global public health and economic toll, and in the U.S. case-fatality rates exceed estimates for the 1918 influenza pandemic 1 . Anti-SARS-CoV-2 monoclonal antibody (mAb)-based therapies have shown sufficient clinical efficacy to receive emergency
Author contributions
Competing interests Additional information Supplementary information The online version contains supplementary material available at https://doi.org/10.1038/s41467-022-32551-2.
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