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Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19.
Chew, Kara W; Moser, Carlee; Daar, Eric S; Wohl, David A; Li, Jonathan Z; Coombs, Robert W; Ritz, Justin; Giganti, Mark; Javan, Arzhang Cyrus; Li, Yijia; Choudhary, Manish C; Deo, Rinki; Malvestutto, Carlos; Klekotka, Paul; Price, Karen; Nirula, Ajay; Fischer, William; Bala, Veenu; Ribeiro, Ruy M; Perelson, Alan S; Fletcher, Courtney V; Eron, Joseph J; Currier, Judith S; Hughes, Michael D; Smith, Davey M.
  • Chew KW; Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA. kchew@mednet.ucla.edu.
  • Moser C; Harvard T.H. Chan School of Public Health, Boston, MA, USA.
  • Daar ES; Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
  • Wohl DA; Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.
  • Li JZ; Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Coombs RW; Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA.
  • Ritz J; Department of Medicine, University of Washington, Seattle, WA, USA.
  • Giganti M; Harvard T.H. Chan School of Public Health, Boston, MA, USA.
  • Javan AC; Harvard T.H. Chan School of Public Health, Boston, MA, USA.
  • Li Y; National Institutes of Health, Bethesda, MD, USA.
  • Choudhary MC; Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Deo R; Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
  • Malvestutto C; Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Klekotka P; Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
  • Price K; Ohio State University Wexner Medical Center, Columbus, OH, USA.
  • Nirula A; Eli Lilly and Company, San Diego, CA, USA.
  • Fischer W; Eli Lilly and Company, San Diego, CA, USA.
  • Bala V; Eli Lilly and Company, San Diego, CA, USA.
  • Ribeiro RM; Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.
  • Perelson AS; UNMC Center for Drug Discovery, University of Nebraska Medical Center, Omaha, NE, USA.
  • Fletcher CV; Clinical Pharmacology & Pharmacometrics, Jounce Therapeutics, Cambridge, MA, USA.
  • Eron JJ; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.
  • Currier JS; Theoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.
  • Hughes MD; Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.
  • Smith DM; Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA.
Nat Commun ; 13(1): 4931, 2022 08 22.
Article in English | MEDLINE | ID: covidwho-2000888
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 11 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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Variants Limits: Adult / Humans Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2022 Document Type: Article Affiliation country: S41467-022-32551-2

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Variants Limits: Adult / Humans Language: English Journal: Nat Commun Journal subject: Biology / Science Year: 2022 Document Type: Article Affiliation country: S41467-022-32551-2