Statistical analysis.
REGRESSION, EVENTS, SECONDARY
A total of 189 events across both groups was required, which would provide ≥89% power and a two-sided significance level of 5% if the hazard ratio (HR) comparing the camostat mesylate group to the placebo group was ≥1.6. Assuming a 70% probability of events within 28 days across both groups and a dropout rate of 20%, approximately 338 patients (169 patients per group) were determined for the sample size.Efficacy was evaluated by full analysis set (FAS; based on the intention-to-treat principle) as the primary result and modified full analysis set (mFAS) as the secondary result. The FAS population was subjects who received at least 1 dose of the investigational product after randomization and had at least one assessment result for COVID-19 symptoms. The mFAS population was subjects included in the FAS whose investigational product (IP) compliance was 70% or higher without deviations from the inclusion/exclusion criteria.The time to clinical improvement of subjective symptoms (days) was analyzed using the Kaplan-Meier curve and Cox proportional hazards regression model with a treatment group as the factor and stratification factors (age and presence of risk factors) as covariates. The proportion with improvement of subjective symptoms up to 7 days was analyzed using a logistic regression model with the treatment group as the factor and stratification factors (age and presence of risk factors) as covariates. For a sensitivity analysis, the log rank test or chi-square test was additionally performed.Clinical data were collected and validated using the Rave Electronic Data Capture system (Medidata Institute, NY, USA). All statistical analyses were performed with SAS version 9.4 (SAS Institute, Inc., Cary, NC, USA).Virus culture was previously planned as an exploratory endpoint in this study’s protocol. For the quantification of SARS-CoV-2, nasopharyngeal swab samples were taken at predetermined intervals. All the clinical samples were transferred to a single central laboratory and were analyzed there. SARS-CoV-2 culture was performed and viral titers were assessed as described previously (