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0 0.5 1 1.5 2+ Hospitalization 25% Improvement Relative Risk Hospitalization, 7000mg.. 52% Hospitalization, 700mg.. -1% Time to symptom impro.. -14% primary Time to symptom i.. (b) -17% primary Progression, 7000mg -1% Progression, 700mg 2% Viral load, 7000mg, day 3 26% Viral load, 700mg, day 3 35% Chew et al. NCT04427501 ACTIV-2/A5401 Bamlanivimab/e.. RCT LATE Is late treatment with bamlanivimab/etesevimab beneficial for COVID-19? RCT 317 patients in the USA (August - November 2020) Improved viral clearance with bamlanivimab/etesevimab (p=0.002) Chew et al., Nature Communications, doi:10.1038/s41467-022-32551-2 Favors bamlanivimab/e.. Favors control
Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19
Chew et al., Nature Communications, doi:10.1038/s41467-022-32551-2, ACTIV-2/A5401, NCT04427501 (history)
Chew et al., Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19, Nature Communications, doi:10.1038/s41467-022-32551-2, ACTIV-2/A5401, NCT04427501
Aug 2022   Source   PDF  
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RCT 317 outpatients in the USA showing faster viral load and inflammatory biomarker decline, but no significant differences in clinical outcomes.
Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron [Liu, Sheward, VanBlargan].
risk of hospitalization, 25.5% lower, RR 0.75, p = 0.60, treatment 6 of 159 (3.8%), control 8 of 158 (5.1%), NNT 78, combined.
risk of hospitalization, 52.1% lower, RR 0.48, p = 0.43, treatment 2 of 48 (4.2%), control 4 of 46 (8.7%), NNT 22, 7000mg, day 28.
risk of hospitalization, 0.9% higher, RR 1.01, p = 1.00, treatment 4 of 111 (3.6%), control 4 of 112 (3.6%), 700mg, day 28.
relative time to symptom improvement, 13.5% higher, relative time 1.14, p = 0.97, treatment 48, control 46, 7000mg, primary outcome.
relative time to symptom improvement, 17.1% higher, relative time 1.17, p = 0.08, treatment 111, control 112, 700mg, primary outcome.
risk of progression, 0.6% higher, RR 1.01, p = 1.00, treatment 42 of 48 (87.5%), control 40 of 46 (87.0%), at least one symptom more severe than baseline, 7000mg.
risk of progression, 2.0% lower, RR 0.98, p = 0.62, treatment 102 of 111 (91.9%), control 105 of 112 (93.8%), NNT 54, at least one symptom more severe than baseline, 700mg.
viral load, 25.6% lower, relative load 0.74, p = 0.002, treatment 48, control 46, 7000mg, day 3.
viral load, 35.3% lower, relative load 0.65, p = 0.07, treatment 111, control 112, 700mg, day 3.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Chew et al., 22 Aug 2022, Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, 26 authors, study period 19 August, 2020 - 15 November, 2020, average treatment delay 6.0 days, trial NCT04427501 (history) (ACTIV-2/A5401).
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This PaperBamlaniv../e..All
Abstract: nature communications Article Antiviral and clinical activity of bamlanivimab in a randomized trial of nonhospitalized adults with COVID-19 Received: 4 May 2022 Check for updates 1234567890():,; 1234567890():,; Accepted: 4 August 2022 Kara W. Chew 1 , Carlee Moser 2, Eric S. Daar3, David A. Wohl 4, Jonathan Z. Li 5, Robert W. Coombs 6,7, Justin Ritz 2, Mark Giganti2, Arzhang Cyrus Javan8, Yijia Li5,14, Manish C. Choudhary5, Rinki Deo5, Carlos Malvestutto9, Paul Klekotka10, Karen Price10, Ajay Nirula10, William Fischer4, Veenu Bala11,15, Ruy M. Ribeiro 12, Alan S. Perelson 12, Courtney V. Fletcher 11, Joseph J. Eron 4, Judith S. Currier 1, ACTIV-2/A5401 Study Team, Michael D. Hughes2,16 & Davey M. Smith 13,16 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 pandemic1. Anti-SARS-CoV-2 monoclonal antibody (mAb)-based therapies have shown sufficient clinical efficacy to receive emergency 1 Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA. 2Harvard T.H. Chan School of Public Health, Boston, MA, USA. 3Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA. 4Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA. 5Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA. 6 Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA. 7Department of Medicine, University of Washington, Seattle, WA, USA. 8National Institutes of Health, Bethesda, MD, USA. 9Ohio State University Wexner Medical Center, Columbus, OH, USA. 10Eli Lilly and Company, San Diego, CA, USA. 11UNMC Center for Drug Discovery, University of Nebraska Medical Center, Omaha, NE, USA. 12Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA. 13Department of Medicine, University of California, San Diego, La Jolla, CA, USA. 14Present address: Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA. 15Present address: Clinical Pharmacology & Pharmacometrics, Jounce..
Late treatment
is less effective
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