Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19

Autor: 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
Rok vydání: 2022
Předmět:
Zdroj: Nature communications. 13(1)
ISSN: 2041-1723
Popis: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT04518410.
Databáze: OpenAIRE
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