Acute Respiratory Distress Syndrome (ARDS)
Conditions
Brief summary
The primary objective is to demonstrate a difference in the time to initial unassisted breathing (UAB) in patients receiving FX06 compared to patients receiving placebo until day 28. • Time to initial unassisted breathing (UAB) until day 28 in both treatment groups
Detailed description
at all available visits and time points between the FX06 and placebo group • Disease progression/improvement, Lung function (partial oxygen pressure in the blood, fraction of inspired oxygen, Horowitz index) at BL, D3, D6, D10 and D28, Systemic inflammation (changes and normalisation in troponin, procalcitonin, CRP, leukocyte count, ferritin, D-dimers, lactate, lactate dehydrogenase, albumin, IL-6), Survival / Mortality, Capillary refill time, Duration of hospital and ICU stay, Subgroup analysis by concomitant medication, age, sex, and ARDS cause, Safety parameters (evaluated for safety set)
Interventions
DRUGphosphate buffered saline.
DRUGFX06
Sponsors
F4-Pharma Ges.m.b.H.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to demonstrate a difference in the time to initial unassisted breathing (UAB) in patients receiving FX06 compared to patients receiving placebo until day 28. • Time to initial unassisted breathing (UAB) until day 28 in both treatment groups | — |
Secondary
| Measure | Time frame |
|---|---|
| at all available visits and time points between the FX06 and placebo group • Disease progression/improvement, Lung function (partial oxygen pressure in the blood, fraction of inspired oxygen, Horowitz index) at BL, D3, D6, D10 and D28, Systemic inflammation (changes and normalisation in troponin, procalcitonin, CRP, leukocyte count, ferritin, D-dimers, lactate, lactate dehydrogenase, albumin, IL-6), Survival / Mortality, Capillary refill time, Duration of hospital and ICU stay, Subgroup analysis by concomitant medication, age, sex, and ARDS cause, Safety parameters (evaluated for safety set) | — |
Countries
France, Germany, Lithuania, Romania, Spain
Outcome results
None listed