Study design, ethics and oversight
critically ill, ARDS
ARDS, CRITICALLY ILL
We conducted a prospective randomized controlled, single-blind multicenter trial administering prostacyclin to critically ill patients with ARDS for 5 days. Two major changes in the design were amended in the protocol. First, patients who did not receive the study therapy according to the physician’s decision were included in the primary analysis population to avoid bias. Second, an extensive subgroup analysis was performed for patients with COVID-19, as the pandemic started during the study period. The study was approved by the Institutional Review Board of the Research Ethics Committee of the University of Tübingen (899/2018AMG1) and the corresponding ethical review boards of all participating centers. The trial was also approved by the Federal Institute for Drugs and Medical Devices (BfArM, EudraCT No. 2016003168-37) and registered at clinicaltrials.gov (NCT03111212). For further details, please see Additional file 