The study is composed of two parts. In part A of the study two active doses of inhaled pegylated adrenomedullin (PEG-ADM) will be compared regarding safety and efficacy to a substance that has no therapeutic effect (placebo) in order to find an optimal and safe of the study drug. In part B of the study the highest dose that is considered safe and has demonstrated efficacy will be taken forward to collect information how well patients suffering from Acute Respiratory Distress Syndrome (ARDS) respond to treatment with inhaled pegylated adrenomedullin (PEG-ADM) compared to treatment with placebo. ARDS is a type of lung failure that cause fluid to build up in the lungs making breathing difficult or impossible.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Participants will receive a lower dose ADM by inhalation
Participants will receive Placebo to BAY1097761 by inhalation
Participants will receive a higher dose ADM by inhalation
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria
Universitätsklinikum AKH Wien
Vienna, Austria
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Fakultni nemocnice v Motole
Prague, Czechia
Masaryk Hospital Usti n/L
Ústí nad Labem, Czechia
Centre Hospitalier Universitaire - Angers
Angers, France
Center Hospitalier Michallon - Grenoble
La Tronche, France
Hôpital du Nord - Marseille
Marseille, France
Hôpital de la Pitié-Salpétrière
Paris, France
Cochin - Paris
Paris, France
...and 12 more locations
VFS in Part B participants
Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)
Time frame: At Day 28
CUI in Part A participants
Clinical Utility Index (CUI) is a summary measure used to compare different treatments, the index score will range between 0 and 1.
Time frame: Up to 7 days
VFS in Part A participants
Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)
Time frame: At Day 28
All-cause mortality in Part A and Part B participants
Time frame: At Day 28, Day 60 and Day 90
Proportion of participants who still require invasive mechanical ventilation support in Part A and Part B participants
Time frame: At Day 28 and Day 60
Ventilator-free days (VFDs) in Part A and Part B participants
Time frame: Within Day 28 and Day 60
VFS in Part A and Part B participants
Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)
Time frame: At Day 60
Integrated analysis on VFS invoving all participants from Part A and Part B
Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)
Time frame: At Day 28 and Day 60
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.