Nature Communications (Aug 2022)
Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19
- 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,
- ACTIV-2/A5401 Study Team,
- Michael D. Hughes,
- Davey M. Smith
Affiliations
- Kara W. Chew
- Department of Medicine, 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
- Department of Medicine, University of North Carolina at Chapel Hill School of Medicine
- Jonathan Z. Li
- Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School
- Robert W. Coombs
- Department of Laboratory Medicine and Pathology, 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
- Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School
- Manish C. Choudhary
- Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School
- Rinki Deo
- Department of Medicine, 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
- Department of Medicine, University of North Carolina at Chapel Hill School of Medicine
- Veenu Bala
- UNMC Center for Drug Discovery, University of Nebraska Medical Center
- Ruy M. Ribeiro
- Theoretical Biology and Biophysics Group, Los Alamos National Laboratory
- Alan S. Perelson
- Theoretical Biology and Biophysics Group, Los Alamos National Laboratory
- Courtney V. Fletcher
- UNMC Center for Drug Discovery, University of Nebraska Medical Center
- Joseph J. Eron
- Department of Medicine, University of North Carolina at Chapel Hill School of Medicine
- Judith S. Currier
- Department of Medicine, David Geffen School of Medicine at University of California, Los Angeles
- ACTIV-2/A5401 Study Team
- Michael D. Hughes
- Harvard T.H. Chan School of Public Health
- Davey M. Smith
- Department of Medicine, University of California, San Diego
- DOI
- https://doi.org/10.1038/s41467-022-32551-2
- Journal volume & issue
-
Vol. 13,
no. 1
pp. 1 – 12
Abstract
In April 2021, Eli Lilly voluntarily asked the FDA to revoke the Emergency Use Authorization for the monoclonal antibody bamlanivimab due to reduced susceptibility in vitro to SARS-CoV-2 variants, not for safety. In this work, authors carry out a placebo-controlled phase 2 evaluation of bamlanivimab in non-hospitalized adults with COVID-19, to determine safety and efficacy.
