Assessing the impact of COVID-19 pandemic on trial conduction
death
COVID-19 INFECTION
To describe the impact of COVID-19 pandemic on trial conduction, with the aim of excluding treatment-specific data patterns by reason due to COVID-19, the following analysis will be performed by treatment group. Baseline characteristics will be summarized by the enrolment period categorized in pre-pandemic, pandemic with restrictive measures, and post-pandemic. The number of visits conducted via telemedicine (including audio-visual connections and telephone contacts), missing data, protocol deviations, end of study by reason, COVID-19 infections, concomitant medications for COVID-19, and death due to COVID-19, will be reported overall and by treatment group. A time to occurrence analysis will be conducted for COVID-19-related protocol deviations using Kaplan-Maier curves and the log-rank test.