Journal
INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES
Volume 122, Issue -, Pages 628-635Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.ijid.2022.06.054
Keywords
Camostat; COVID-19; Efficacy; Neutralizing antibodies; Randomized controlled trial; Safety
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This study assessed the efficacy and safety of 300 mg camostat mesylate three times daily in a fasted state to treat early phase COVID-19. The results showed that camostat mesylate was not found to be effective as an antiviral drug against SARS-CoV-2.
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. (C) 2022 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.
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