Viral and symptom rebound following anti-SARS-CoV-2 monoclonal antibody therapy in a randomized placebo-controlled trial

Kara W Chew; Brooke McGinley; Carlee Moser; Jonathan Z Li; Teresa H Evering; Justin Ritz; Arzhang Cyrus Javan; David Margolis; David A Wohl; Michael D Hughes; Eric S Daar; Judith S Currier; Joseph J Eron; Davey M Smith; ACTIV-2/A5401 Study Team

doi:10.1093/infdis/jiae501

Viral and symptom rebound following anti-SARS-CoV-2 monoclonal antibody therapy in a randomized placebo-controlled trial

J Infect Dis. 2024 Oct 14:jiae501. doi: 10.1093/infdis/jiae501. Online ahead of print.

Authors

Collaborators

ACTIV-2/A5401 Study Team:
Kara Chew, David Davey Smith, Eric Daar, David Wohl, Judith Currier, Joseph Eron, Arzhang Cyrus Javan, Michael Hughes, Carlee Moser, Mark Giganti, Justin Ritz, Lara Hosey, Jhoanna Roa, Nilam Patel, Kelly Colsh, Irene Rwakazina, Justine Beck, Scott Sieg, Jonathan Li, Courtney Fletcher, William Fischer, Teresa Evering, Rachel Bender Ignacio, Sandra Cardoso, Katya Corado, Prasanna Jagannathan, Nikolaus Jilg, Alan Perelson, Sandy Pillay, Cynthia Riviere, Upinder Singh, Babafemi Taiwo, Joan Gottesman, Matthew Newell, Susan Pedersen, Joan Dragavon, Cheryl Jennings, Brian Greenfelder, William Murtaugh, Jan Kosmyna, Morgan Gapara, Akbar Shahkolahi

Affiliations

¹ David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
² Boston University School of Public Health, Boston, MA, USA.
³ Harvard T.H. Chan School of Public Health, Boston, MA, USA.
⁴ Massachusetts General Hospital and Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
⁵ Weill Cornell Medicine, New York, NY, USA.
⁶ DTM&H, National Institutes of Health, Bethesda, MD, USA.
⁷ Brii Biosciences, Durham, NC, USA.
⁸ University of North Carolina, Chapel Hill, Chapel Hill, NC, USA.
⁹ Lundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
¹⁰ University of California, San Diego, San Diego, CA, USA.

PMID: 39400063
DOI: 10.1093/infdis/jiae501

Abstract

We explored viral and symptom rebound after COVID-19 amubarvimab/romlusevimab monoclonal antibody therapy vs placebo in the randomized ACTIV-2/A5401 trial. Participants underwent nasal SARS-CoV-2 PCR 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% CI 0.52, 1.75, analysis population) n=574); <1% had both viral/symptom rebound.

Keywords: COVID-19; COVID-19 treatment; SARS-CoV-2; monoclonal antibodies; non-hospitalized adults; symptom rebound; viral rebound.

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Abstract

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