Discussion
hypoxemia, infection
INFECTION
The occurrence of COVID-19 during trial preparation affected IMP production, and COVID-19 in trial participants may generate false safety signals if attributed to the trial drugs. Therefore, we included guidance on COVID-19 testing based on symptoms or hypoxemia into the trial-specific manuals and discussed preventive infection control measures with the study sties. Furthermore, to enable on-site monitoring during international lockdowns, we contracted local monitors instead of relying on international travel.