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Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial
- Source :
- International Journal of Infectious Diseases, Vol 122, Iss , Pp 628-635 (2022)
- Publication Year :
- 2022
- Publisher :
- Elsevier, 2022.
-
Abstract
- Objectives: This study aimed to assess the efficacy and safety of 300 mg camostat mesylate three times daily in a fasted state to treat early phase COVID-19 in an ambulatory setting. Methods: We conducted a phase II randomized controlled trial in symptomatic (maximum 5 days) and asymptomatic patients with confirmed COVID-19 infection. Patients were randomly assigned in a 2:1 ratio to receive either camostat mesylate or a placebo. Outcomes included change in nasopharyngeal viral load, time to clinical improvement, the presence of neutralizing antibodies, and safety. Results: Of 96 participants randomized between November 2020 and June 2021, analyses were performed on the data of 90 participants who completed treatment (N = 61 camostat mesylate, N = 29 placebo). The estimated mean change in cycle threshold between day 1 and day 5 between the camostat and placebo group was 1.183 (P = 0.511). The unadjusted hazard ratio for clinical improvement in the camostat group was 0.965 (95% confidence interval, 0.480-1.942, P = 0.921 by Cox regression). The percentage distribution of the 50% neutralizing antibody titer at day 28 visit and frequency of adverse events were similar between the two groups. Conclusion: Under this protocol, camostat mesylate was not found to be effective as an antiviral drug against SARS-CoV-2.Trial registration: ClinicalTrials.gov NCT04625114; November 12, 2020.
Details
- Language :
- English
- ISSN :
- 12019712
- Volume :
- 122
- Issue :
- 628-635
- Database :
- Directory of Open Access Journals
- Journal :
- International Journal of Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.b977e1e64d6b4df4897cb4a0ff30160f
- Document Type :
- article
- Full Text :
- https://doi.org/10.1016/j.ijid.2022.06.054