Additional analyses to account for the COVID-19 pandemic
coronavirus disease, death, COVID-19-related intercurrent events, COVID-19-related infections
ADVERSE EVENTS, EMA
Prior to the COVID-19 pandemic, the primary analysis was planned using an ITT approach, by properly accounting for missing data and premature study termination. Despite the occurrence of the COVID-19 pandemic, the original primary objective of TUDCA-ALS study remains unchanged, implying that the estimate of TUDCA effect is not confounded by COVID-19 pandemic related disruptions. However, COVID-19-related intercurrent events need to be properly accounted for to ensure an appropriate interpretation of the trial results [In application of the COVID-19 amendment, changes have been made to adapt the electronic case report forms for the study visits performed after February 3, 2020. The main changes include the implementation of telemedicine visits, the specification of missing data due to COVID-19, collecting information on COVID-19 protocol deviations, COVID-19 vaccination, and study termination due to COVID-19. Information on COVID-19-related infections, therapy, and death are expected to be reported in the descriptions of protocol deviations, as well as in the form on concomitant medication and adverse events. All these data will be used to perform additional analyses in accordance with the specific EMA guidelines on the implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials [