Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19
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. Trial Registration: ClinicalTrials.gov Identifier: NCT04518410.
- Research Organization:
- Los Alamos National Laboratory (LANL), Los Alamos, NM (United States)
- Sponsoring Organization:
- National Institutes of Health (NIH); USDOE; USDOE Laboratory Directed Research and Development (LDRD) Program
- Grant/Contract Number:
- 89233218CNA000001
- OSTI ID:
- 1882978
- Report Number(s):
- LA-UR-22-20405; 4931; PII: 32551
- Journal Information:
- Nature Communications, Journal Name: Nature Communications Journal Issue: 1 Vol. 13; ISSN 2041-1723
- Publisher:
- Nature Publishing GroupCopyright Statement
- Country of Publication:
- United Kingdom
- Language:
- English
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