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

Author

Listed:
  • Kara W. Chew

    (David Geffen School of Medicine at University of California, Los Angeles)

  • Carlee Moser

    (Harvard T.H. Chan School of Public Health)

  • Eric S. Daar

    (Lundquist Institute at Harbor-UCLA Medical Center)

  • David A. Wohl

    (University of North Carolina at Chapel Hill School of Medicine)

  • Jonathan Z. Li

    (Brigham and Women’s Hospital, Harvard Medical School)

  • Robert W. Coombs

    (University of Washington
    University of Washington)

  • Justin Ritz

    (Harvard T.H. Chan School of Public Health)

  • Mark Giganti

    (Harvard T.H. Chan School of Public Health)

  • Arzhang Cyrus Javan

    (National Institutes of Health)

  • Yijia Li

    (Brigham and Women’s Hospital, Harvard Medical School
    University of Pittsburgh)

  • Manish C. Choudhary

    (Brigham and Women’s Hospital, Harvard Medical School)

  • Rinki Deo

    (Brigham and Women’s Hospital, Harvard Medical School)

  • Carlos Malvestutto

    (Ohio State University Wexner Medical Center)

  • Paul Klekotka

    (Eli Lilly and Company)

  • Karen Price

    (Eli Lilly and Company)

  • Ajay Nirula

    (Eli Lilly and Company)

  • William Fischer

    (University of North Carolina at Chapel Hill School of Medicine)

  • Veenu Bala

    (University of Nebraska Medical Center
    Clinical Pharmacology & Pharmacometrics, Jounce Therapeutics)

  • Ruy M. Ribeiro

    (Los Alamos National Laboratory)

  • Alan S. Perelson

    (Los Alamos National Laboratory)

  • Courtney V. Fletcher

    (University of Nebraska Medical Center)

  • Joseph J. Eron

    (University of North Carolina at Chapel Hill School of Medicine)

  • Judith S. Currier

    (David Geffen School of Medicine at University of California, Los Angeles)

  • Michael D. Hughes

    (Harvard T.H. Chan School of Public Health)

  • Davey M. Smith

    (University of California, San Diego)

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.

Suggested Citation

  • 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 , 2022. "Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19," Nature Communications, Nature, vol. 13(1), pages 1-12, December.
    • Handle: RePEc:nat:natcom:v:13:y:2022:i:1:d:10.1038_s41467-022-32551-2
    DOI: 10.1038/s41467-022-32551-2
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