One Week of Oral Camostat Versus Placebo in Non-Hospitalized Adults with Mild-to-Moderate COVID-19: A Randomized Controlled Phase 2 Trial.

Camostat inhibits 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 non-hospitalized adults. 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 (NP) swabs through day 14, and grade ≥3 treatment-emergent adverse events (TEAEs) through day 28. 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=0.99). There were no significant differences in the proportion of participants with SARS-CoV-2 RNA camostat arm and 5 (4.7%) in the placebo arm were hospitalized; one participant in the camostat arm subsequently died. Grade ≥3 TEAEs occurred in 10.1% of camostat vs. 6.5% of placebo participants (p=0.35). In a phase 2 study of non-hospitalized adults with mild-to-moderate COVID-19, oral camostat did not accelerate viral clearance nor time to symptom improvement, nor reduce hospitalizations or deaths. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT04518410.). © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Citation

Nikolaus Jilg, Kara W Chew, Mark J Giganti, Eric S Daar, David A Wohl, Arzhang Cyrus Javan, Amy Kantor, Carlee Moser, Robert W Coombs, Gene Neytman, Keila Hoover, Atasi Jana, Phil A Hart, Alexander L Greninger, Bob Szurgot, Joseph J Eron, Judith S Currier, Michael D Hughes, Davey M Smith, Jonathan Z Li, ACTIV-2/A5401 Study Team. One Week of Oral Camostat Versus Placebo in Non-Hospitalized Adults with Mild-to-Moderate COVID-19: A Randomized Controlled Phase 2 Trial. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2023 Jun 05

PMID: 37279602

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