One Week of Oral Camostat Versus Placebo in Nonhospitalized Adults With Mild-to-Moderate Coronavirus Disease 2019: A Randomized Controlled Phase 2 Trial
Author:
Jilg Nikolaus1ORCID, Chew Kara W2, Giganti Mark J3, Daar Eric S4, Wohl David A5, Javan Arzhang Cyrus6, Kantor Amy3, Moser Carlee3, Coombs Robert W7, Neytman Gene8, Hoover Keila9, Jana Atasi10, Hart Phil A11, Greninger Alexander L7, Szurgot Bob10, Eron Joseph J5, Currier Judith S12, Hughes Michael D3, Smith Davey M13, Li Jonathan Z14, Chew Kara, Smith David, Daar Eric, Wohl David, Currier Judith, Eron Joseph, Javan Arzhang Cyrus, Hughes Michael, Moser Carlee, Giganti Mark, Ritz Justin, Hosey Lara, Roa Jhoanna, Patel Nilam, Colsh Kelly, Rwakazina Irene, Beck Justine, Sieg Scott, Li Jonathan, Fletcher Courtney, Fischer William, Evering Teresa, Coombs Robert, Ignacio Rachel Bender, Cardoso Sandra, Corado Katya, Jagannathan Prasanna, Jilg Nikolaus, Perelson Alan, Pillay Sandy, Riviere Cynthia, Singh Upinder, Taiwo Babafemi, Gottesman Joan, Newell Matthew, Pedersen Susan, Dragavon Joan, Jennings Cheryl, Greenfelder Brian, Murtaugh William, Kosmyna Jan, Gapara Morgan, Shahkolahi Akbar, Szurgot Bob,
Affiliation:
1. Department of Medicine, Massachusetts General Hospital and Department of Medicine, Brigham Women's Hospital, Harvard Medical School , Boston, Massachusetts , USA 2. Department of Medicine, University of California , Los Angeles, California , USA 3. Harvard T.H. Chan School of Public Health , Boston, Massachusetts , USA 4. Department of Medicine, University of California Los Angeles Center , Torrance, California , USA 5. Department of Medicine, University of North Carolina , Chapel Hill, North Carolina , USA 6. Division of AIDS, National Institutes of Health , Rockville, Maryland , USA 7. Department of Medicine, University of Washington , Seattle, Washington , USA 8. Quantum Clinical Trials , Miami Beach, Florida , USA 9. Miami Clinical Research , Miami, Florida , USA 10. Sagent Pharmaceuticals , Schaumburg, Illinois , USA 11. Department of Medicine, The Ohio State University Wexner Medical Center , Columbus, Ohio , USA 12. Department of Medicine, University of Los Angeles , Los Angeles, California , USA 13. Department of Medicine, University of California, San Diego , San Diego, California , USA 14. Department of Medicine, Brigham and Women's Hospital, Harvard Medical School , Boston, Massachusetts , USA
Abstract
Abstract
Background
Camostat inhibits severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in vitro. We studied the safety and efficacy of camostat in ACTIV-2/A5401, a phase 2/3 platform trial of therapeutics for COVID-19 in nonhospitalized adults.
Methods
We conducted a phase 2 study in adults with mild-to-moderate COVID-19 randomized to oral camostat for 7 days or a pooled placebo arm. Primary outcomes were time to improvement in COVID-19 symptoms through day 28, proportion of participants with SARS-CoV-2 RNA below the lower limit of quantification (LLoQ) from nasopharyngeal swabs through day 14, and grade ≥3 treatment-emergent adverse events (TEAEs) through day 28.
Results
Of 216 participants (109 randomized to camostat, 107 to placebo) who initiated study intervention, 45% reported ≤5 days of symptoms at study entry and 26% met the protocol definition of higher risk of progression to severe COVID-19. Median age was 37 years. Median time to symptom improvement was 9 days in both arms (P = .99). There were no significant differences in the proportion of participants with SARS-CoV-2 RNA <LLoQ on days 3, 7, and 14. Through day 28, 6 (5.6%) participants in the camostat arm and 5 (4.7%) in the placebo arm were hospitalized; 1 participant in the camostat arm subsequently died. Grade ≥3 TEAEs occurred in 10.1% of camostat versus 6.5% of placebo participants (P = .35).
Conclusions
In a phase 2 study of nonhospitalized adults with mild-to-moderate COVID-19, oral camostat did not accelerate viral clearance or time to symptom improvement, or reduce hospitalizations or deaths.
Clinical Trials Registration. ClinicalTrials.gov identifier: NCT 04518410.
Funder
National Institute of Allergy and Infectious Diseases National Institutes of Health
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Microbiology (medical)
Cited by
1 articles.
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