A multicenter, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of camostat mesilate in patients with COVID-19 (CANDLE study) - BMC Medicine

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A multicenter, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the efficacy and safety of camostat mesilate in patients with COVID-19 (CANDLE study) - BMC Medicine
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Camostat mesilate is not an effective treatment for mild to moderate SARS-CoV-2 infection, reports a study published in BMCMedicine.

Exploratory efficacy endpoints were the SARS-CoV-2 viral load , presence of lung lesions on chest imaging, time to resolution of clinical symptoms, proportion of patients in whom the clinical symptoms resolved, and antibody responses .

Safety evaluations included monitoring of adverse events, laboratory tests, vital signs, and 12-lead electrocardiography throughout the study.The objective of this study was to establish the superiority of camostat mesilate over placebo in patients with COVID-19 using the time to negative SARS-CoV-2 test as the primary endpoint.

A modified intention-to-treat analysis set was used for efficacy analyses by excluding any patients who tested negative for SARS-CoV-2 on day 1 . All analyses were performed on an as-randomized basis. The safety analysis set comprised all patients who received at least one dose of the allocated drug.

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