| Autor: |
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 |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
|
| Zdroj: |
International Journal of Infectious Diseases, Vol 122, Iss , Pp 628-635 (2022) |
| Druh dokumentu: |
article |
| ISSN: |
1201-9712 |
| DOI: |
10.1016/j.ijid.2022.06.054 |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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