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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

Tobback et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.06.054, NCT04625114
Sep 2022  
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Hospitalization -36% Improvement Relative Risk Recovery 8% Camostat  Tobback et al.  EARLY TREATMENT  RCT Is early treatment with camostat beneficial for COVID-19? RCT 96 patients in Belgium (November 2020 - June 2021) Trial underpowered for serious outcomes c19early.org Tobback et al., Int. J. Infectious Dis.., Sep 2022 Favorscamostat Favorscontrol 0 0.5 1 1.5 2+
RCT 90 outpatients showing no significant difference in viral load or time to clinical improvement with camostat mesylate. The trial was discontinued early and did not reach the intended sample size. Authors note that combining camostat with a cathepsin inhibitor may improve efficacy.
risk of hospitalization, 36.4% higher, RR 1.36, p = 1.00, treatment 3 of 66 (4.5%), control 1 of 30 (3.3%).
risk of no recovery, 7.7% lower, HR 0.92, p = 0.84, treatment 61, control 29, adjusted per study, inverted to make HR<1 favor treatment, multivariable, Cox proportional hazards.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Tobback et al., 30 Sep 2022, Randomized Controlled Trial, placebo-controlled, Belgium, peer-reviewed, median age 40.0, 13 authors, study period November 2020 - June 2021, trial NCT04625114 (history). Contact: els.tobback@uzgent.be, sabine.buysse2@uzgent.be, lucas.vandooren@uzgent.be, vanherrewege@uzgent.be, cyril.barbezange@sciensano.be, veronik.hutse@sciensano.be, marta.romano@sciensano.be, isabelle.thomas.xyz@gmail.com, elizaveta.padalko@uzgent.be, steven.callens@uzgent.be.
This PaperMiscellaneousAll
Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial
Els Tobback, Sophie Degroote, Sabine Buysse, Liesbeth Delesie, Lucas Van Dooren, Sophie Vanherrewege, Cyril Barbezange, Veronik Hutse, Marta Romano, Isabelle Thomas, Elizaveta Padalko, Steven Callens, Marie-Angélique De Scheerder
International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.06.054
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.
Conflict of interest The authors have no conflicts of interest to declare. Author contributions MADS conceived and designed the analysis, contributed to data collectiona and analysis and review, ET wrote the paper and contributed to data collection and analysis; LD, SB, SVH and LVD contributed to data collection; SDG, VH, MR, IT, EP contributed to data analysis; SC contributed to the protocol and review.
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