학술논문
One Week of Oral Camostat Versus Placebo in Nonhospitalized Adults With Mild-to-Moderate Coronavirus Disease 2019: A Randomized Controlled Phase 2 Trial
Document Type
article
Author
Jilg, Nikolaus; Chew, Kara W; Giganti, Mark J; Daar, Eric S; Wohl, David A; Javan, Arzhang Cyrus; Kantor, Amy; Moser, Carlee; Coombs, Robert W; Neytman, Gene; Hoover, Keila; Jana, Atasi; Hart, Phil A; Greninger, Alexander L; Szurgot, Bob; Eron, Joseph J; Currier, Judith S; Hughes, Michael D; Smith, Davey M; Li, Jonathan Z; Chew, Kara; Smith, David; Daar, Eric; Wohl, David; Currier, Judith; Eron, Joseph; Hughes, Michael; 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; 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
Source
Clinical Infectious Diseases. 77(7)
Subject
Language
Abstract
BackgroundCamostat 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.MethodsWe 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.ResultsOf 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 ConclusionsIn 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: NCT04518410.