%0 Journal Article %J Int J Infect Dis %D 2022 %T Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial. %A Els Tobback %A Sophie Degroote %A Sabine Buysse %A Liesbeth Delesie %A Lucas Van Dooren %A Sophie Vanherrewege %A Cyril Barbezange %A Veronik Hutse %A Marta Romano %A Isabelle Thomas %A Padalko, Elizaveta %A S. Callens %A Marie-Angélique De Scheerder %K COVID-19 %K Double-Blind Method %K Esters %K Guanidines %K Humans %K SARS-CoV-2 %K Treatment Outcome %X

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.

%B Int J Infect Dis %V 122 %8 2022 Sep %G eng %R 10.1016/j.ijid.2022.06.054