Viral and Symptom Rebound Following Anti–Severe Acute Respiratory Syndrome Coronavirus 2 Monoclonal Antibody Therapy in a Randomized Placebo-Controlled Trial
We explored viral and symptom rebound after coronavirus disease 2019 amubarvimab-romlusevimab monoclonal antibody therapy versus placebo in the randomized ACTIV-2/A5401 trial. Participants underwent nasal severe acute respiratory syndrome coronavirus 2 polymerase chain reaction testing at study days 3, 7, 14, and 28. Viral rebound was defined as RNA ≥3 and ≥0.5 log10 copies/mL increase from day 3 or 7, and symptom rebound as hospitalization or any moderate/severe symptom for ≥2 days after initial symptom improvement. There was no difference in viral rebound (∼5%/arm) (analysis population n = 713) or symptom rebound among participants who initially improved (hazard ratio, 0.95 [95% confidence interval, .52-1.75]; analysis population n = 574); <1% had both viral/symptom rebound.
Authors
- William A. Fischer (ORCID: https://orcid.org/0000-0002-4900-098X)
- Sandy Pillay
- Joan Dragavon
- David M. Margolis (ORCID: https://orcid.org/0000-0001-5714-0002)
- Irene Rwakazina
- Brooke McGinley (ORCID: https://orcid.org/0000-0001-9717-6165)
- Kara W Chew (ORCID: https://orcid.org/0000-0003-4865-4348)
- Justine Beck
- Susan Pedersen
- Nikolaus Jilg (ORCID: https://orcid.org/0000-0001-9154-2769)
- Kelly Colsh
- Rachel Bender Ignacio (ORCID: https://orcid.org/0000-0001-6167-1447)
- Babafemi Taiwo (ORCID: https://orcid.org/0000-0003-2661-9103)
- Akbar Shahkolahi
- Courtney Vail Fletcher (ORCID: https://orcid.org/0000-0002-3703-7849)
- William Murtaugh
- David R. Smith (ORCID: https://orcid.org/0000-0002-7330-4262)
- Joseph J. Eron (ORCID: https://orcid.org/0000-0002-4938-0644)
- Prasanna Jagannathan (ORCID: https://orcid.org/0000-0001-6305-758X)
- Carlee Moser (ORCID: https://orcid.org/0000-0001-5601-9112)
- Nilam Patel
- Katya Corado
- Morgan Gapara
- Brian Greenfelder
- Arzhang Cyrus Javan
- Jonathan Z. Li (ORCID: https://orcid.org/0000-0001-9914-9662)
- Scott F. Sieg (ORCID: https://orcid.org/0000-0002-1769-8682)
- Cynthia Riviere
- Davey M. Smith (ORCID: https://orcid.org/0000-0003-3603-1733)
- Lara Hosey
- Alan S. Perelson (ORCID: https://orcid.org/0000-0002-2455-0002)
- David A. Wohl (ORCID: https://orcid.org/0000-0002-7764-0212)
- Upinder Singh (ORCID: https://orcid.org/0000-0003-0630-0306)
- Matthew Newell
- Teresa H. Evering
- Jan Kosmyna
- Joan Gottesman
- Cheryl Jennings (ORCID: https://orcid.org/0009-0002-3508-5350)
- Jhoanna Roa
- Eric S. Daar (ORCID: https://orcid.org/0000-0003-1880-7331)
- Mark J Giganti (ORCID: https://orcid.org/0000-0003-2255-9756)
- Judith S. Currier (ORCID: https://orcid.org/0000-0003-4279-4737)
- Sandra Wagner Cardoso (ORCID: https://orcid.org/0000-0001-5230-0003)
- Justin Ritz (ORCID: https://orcid.org/0000-0001-6307-4849)
- Jonathan Li (ORCID: https://orcid.org/0000-0002-8004-0015)
- Michael D. Hughes (ORCID: https://orcid.org/0000-0001-8562-2316)
Institutions
- Boston University (US)
- University of North Carolina at Chapel Hill (US)
- Brigham and Women's Hospital (US)
- National Institutes of Health (US)
- Harvard University (US)
- University of California, Los Angeles (US)
- Cornell University (US)
- UCLA Medical Center (US)
- University of California San Diego (US)
- Cancer Research And Biostatistics (US)
- National Institute of Allergy and Infectious Diseases (US)
- Harbor–UCLA Medical Center (US)
- Weill Cornell Medicine (US)
Publication Details
- Journal
- The Journal of Infectious Diseases
- Published
- 2024-10-14
- DOI
- https://doi.org/10.1093/infdis/jiae501
- Primary Topic
- SARS-CoV-2 and COVID-19 Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Gilead Sciences
- University of Washington
- ACT Government
- Norges Idrettshøgskole
- National Institutes of Health
- National Institute of Allergy and Infectious Diseases