id author title date pages extension mime words sentences flesch summary cache txt cord-004450-daxz9yhp Haeberle, Helene Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study 2020-03-04 .txt text/plain 5848 383 48 Several preclinical studies have revealed a beneficial effect of iloprost on the control of pulmonary inflammation, and in a small number of patients with ARDS, iloprost treatment resulted in improved oxygenation. For safety reasons, after treatment of 100 patients (day 28 after last dose investigational medicinal product [IMP] Patient 100) within the study, an interim analysis for an increased risk for pulmonary hemorrhage ≥ grade III according to Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) Version 5.0 in the treatment (iloprost) arm will be performed and the results discussed with the Data and Safety Monitoring Board (DSMB). When possible, however, the patient or his legal representative is to be informed both in writing and verbally by the investigator before any study-specific procedure is Iloprost or NaCl 0.9% (control) X X X X X Clinical assessment including outcome X X X X X X X X X Laboratory testing X X X X X X X X Adverse/serious adverse event monitoring X X X X X X X Plasma biomarkers X X X X X X Barthel Index X X X X SOFA score X X X X X X X X Health-related questionnaire X VES X performed. ./cache/cord-004450-daxz9yhp.txt ./txt/cord-004450-daxz9yhp.txt