There is one clinical trial.
This is a pragmatic, adaptive, open-label, randomized, multicenter phase II/III study consisting of two parts: Phase II and Phase III. In both study parts, patients will be randomized to two treatment arms (Arm A: best supportive care [BSC] + IFX-1; Arm B: BSC alone). After all patients are treated in Phase II, an interim analysis will be performed to assess the clinical benefit of the treatment using the assessed clinical parameters.
Description: Relative change (%) from baseline in Oxygenation Index (PaO2 / FiO2) to day 5.
Measure: Change in PaO2/FiO2 Time: Baseline to Day 5Description: Number of patients (%) achieving an Early Response
Measure: Patients achieving early response Time: Baseline to Day 7