Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial
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 patient...
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2022-09-01
|
| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971222003885 |
| _version_ | 1798004682873896960 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Els Tobback |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T12:27:21Z |
| format | Article |
| id | doaj.art-b977e1e64d6b4df4897cb4a0ff30160f |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-04-11T12:27:21Z |
| publishDate | 2022-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-b977e1e64d6b4df4897cb4a0ff30160f2022-12-22T04:23:54ZengElsevierInternational Journal of Infectious Diseases1201-97122022-09-01122628635Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trialEls Tobback0Sophie Degroote1Sabine Buysse2Liesbeth Delesie3Lucas Van Dooren4Sophie Vanherrewege5Cyril Barbezange6Veronik Hutse7Marta Romano8Isabelle Thomas9Elizaveta Padalko10Steven Callens11Marie-Angélique De Scheerder12Department of General Internal Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, BelgiumDepartment of General Internal Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, BelgiumDepartment of General Internal Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, BelgiumDepartment of General Internal Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, BelgiumDepartment of General Internal Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, BelgiumDepartment of General Internal Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, BelgiumNational Influenza Centre, Sciensano, Rue Juliette Wytsmanstraat 14, 1050 Brussels, BelgiumNational Influenza Centre, Sciensano, Rue Juliette Wytsmanstraat 14, 1050 Brussels, BelgiumImmune Response Service, Sciensano, Rue Juliette Wytsmanstraat 14, 1050 Brussels, BelgiumNational Influenza Centre, Sciensano, Rue Juliette Wytsmanstraat 14, 1050 Brussels, BelgiumDepartment of Laboratory Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, BelgiumDepartment of General Internal Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, BelgiumDepartment of General Internal Medicine, Ghent University Hospital, Corneel Heymanslaan 10, 9000 Ghent, Belgium; Corresponding author.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.http://www.sciencedirect.com/science/article/pii/S1201971222003885CamostatCOVID-19EfficacyNeutralizing antibodiesRandomized controlled trialSafety |
| spellingShingle | 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 Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial International Journal of Infectious Diseases Camostat COVID-19 Efficacy Neutralizing antibodies Randomized controlled trial Safety |
| title | Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial |
| title_full | Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial |
| title_fullStr | Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial |
| title_full_unstemmed | Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial |
| title_short | Efficacy and safety of camostat mesylate in early COVID-19 disease in an ambulatory setting: a randomized placebo-controlled phase II trial |
| title_sort | efficacy and safety of camostat mesylate in early covid 19 disease in an ambulatory setting a randomized placebo controlled phase ii trial |
| topic | Camostat COVID-19 Efficacy Neutralizing antibodies Randomized controlled trial Safety |
| url | http://www.sciencedirect.com/science/article/pii/S1201971222003885 |
| work_keys_str_mv | AT elstobback efficacyandsafetyofcamostatmesylateinearlycovid19diseaseinanambulatorysettingarandomizedplacebocontrolledphaseiitrial AT sophiedegroote efficacyandsafetyofcamostatmesylateinearlycovid19diseaseinanambulatorysettingarandomizedplacebocontrolledphaseiitrial AT sabinebuysse efficacyandsafetyofcamostatmesylateinearlycovid19diseaseinanambulatorysettingarandomizedplacebocontrolledphaseiitrial AT liesbethdelesie efficacyandsafetyofcamostatmesylateinearlycovid19diseaseinanambulatorysettingarandomizedplacebocontrolledphaseiitrial AT lucasvandooren efficacyandsafetyofcamostatmesylateinearlycovid19diseaseinanambulatorysettingarandomizedplacebocontrolledphaseiitrial AT sophievanherrewege efficacyandsafetyofcamostatmesylateinearlycovid19diseaseinanambulatorysettingarandomizedplacebocontrolledphaseiitrial AT cyrilbarbezange efficacyandsafetyofcamostatmesylateinearlycovid19diseaseinanambulatorysettingarandomizedplacebocontrolledphaseiitrial AT veronikhutse efficacyandsafetyofcamostatmesylateinearlycovid19diseaseinanambulatorysettingarandomizedplacebocontrolledphaseiitrial AT martaromano efficacyandsafetyofcamostatmesylateinearlycovid19diseaseinanambulatorysettingarandomizedplacebocontrolledphaseiitrial AT isabellethomas efficacyandsafetyofcamostatmesylateinearlycovid19diseaseinanambulatorysettingarandomizedplacebocontrolledphaseiitrial AT elizavetapadalko efficacyandsafetyofcamostatmesylateinearlycovid19diseaseinanambulatorysettingarandomizedplacebocontrolledphaseiitrial AT stevencallens efficacyandsafetyofcamostatmesylateinearlycovid19diseaseinanambulatorysettingarandomizedplacebocontrolledphaseiitrial AT marieangeliquedescheerder efficacyandsafetyofcamostatmesylateinearlycovid19diseaseinanambulatorysettingarandomizedplacebocontrolledphaseiitrial |