Trial Condition(s):
Acute respiratory distress syndrome
This study collects information on the safety of inhaled pegylated adrenomedullin (PEG-ADM), how the drug is tolerated and how it affects patients suffering from a type of lung failure that cause fluid to build up in the lungs making breathing difficult (ARDS) (SEAL)
Trial Purpose
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.
Inclusion Criteria
- ≥18 years of age at the time of inclusion into study. - Invasively mechanically ventilated acute respiratory distress syndrome [ARDS] patients (diagnosed according to Berlin definition of ARDS, including positive end-expiratory pressure [PEEP] of ≥5 cm H2O, X-ray (or CT scan) indicative of ARDS: bilateral opacities not fully explained by cardiac failure, fluid overload, lobar/lung collapse, effusions or nodules). - Initial diagnosis of mild, moderate or severe ARDS prior to study inclusion, with acute onset of ARDS within 1 week after suspected trigger factor of -- Pneumonia -- Aspiration -- Sepsis -- Pancreatitis - Prior to randomization, hypoxemia with PaO2:FiO2 ≤300 mmHg continuously observed for a period of ≥4 hours (with values of ≥2 arterial blood gas [ABG] analyses during that time, with the last value obtained timely (generally ≤3 hours) prior to randomization), under ventilation with minimum PEEP ≥8 cm H2O. - Time from first meeting the last diagnostic ARDS criterion (Berlin criteria) to randomization must be ≤48 hours. - For Study Part A: ARDS patients for whom measurements of extra-vascular lung water are regarded as medically indicated by the treating physician, and these measurements are planned as part of their clinical care, from Study Day 1 up to Study Day 7 (if then still intubated).
Exclusion Criteria
- Any value of a PaO2:FiO2 ratio >300 mmHg within a time interval of 4 hours before randomization - Rescue therapy (e.g. inhalation of nitric oxide gas and/or inhalation of prostacyclin analogues, or extra corporeal membrane oxygenation [ECMO] / extra corporeal CO2 removal [ECCO2R]) already initiated at screening and/or Study Day 1 (prior to first dose of the study intervention) - Moribund participants not expected to survive 24 hours (clinical decision) - Expected duration of invasive mechanical ventilation less than 48 hours (clinical decision) - History of co-morbidities requiring long-term/home oxygen use (e.g. severe chronic obstructive pulmonary disease [COPD], pulmonary fibrosis) or non-invasive ventilation (except for sleep apnea management), or making weaning per se improbable (e.g. ALS, muscular dystrophy) - Smoke inhalation injury, extensive burns or trauma/head injury as concomitant condition - History of pneumectomy, lung lobectomy or lung transplant - Diffuse alveolar hemorrhage from vasculitis - Current lung malignancy (incl. lung metastasis), or other malignancy requiring chemotherapy or radiation within the last month - Chronic kidney disease with a history of renal replacement therapy (e.g. dialysis) - Chronic liver disease Child-Pugh Class C - Chronic heart failure NYHA IV - Known hypersensitivity to polyethyleneglycol (PEG, Macrogol) - Participation in other interventional studies involving pharmacological interventions, or biological or cell therapy interventions - Diagnosis of COVID-19 pneumonia within 6 weeks prior to study inclusion. History of SARS-CoV-2 infection (positive test based on nucleic acid amplification technology or positive antigen test) without COVID-19 pneumonia does not exclude patients
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Fakultni nemocnice Kralovske Vinohrady Praha, Czech Republic, 10034 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Masaryk Hospital Usti n/L Usti nad Labem, Czech Republic, 401 13 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Fakultni nemocnice v Motole Praha 5, Czech Republic, 150 06 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Medizinische Universität Innsbruck Innsbruck, Austria, 6020 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim Köln, Germany, 51109 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Klinikum Oldenburg AöR Oldenburg, Germany, 26133 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Medizinische Hochschule Hannover (MHH) Hannover, Germany, 30625 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Hospital de la Santa Creu i de Sant Pau Barcelona, Spain, 08041 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Corporació Sanitària Parc Taulí Sabadell, Spain, 08208 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Ciutat Sanitaria i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations ASST Santi Paolo e Carlo Milano, Italy, 20142 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Cochin - Paris PARIS, France, 75014 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Center Hospitalier Michallon - Grenoble LA TRONCHE, France, 38700 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Charité - Universitätsmedizin Berlin Berlin, Germany, 10117 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Centre Hospitalier Universitaire - Angers ANGERS CEDEX 09, France, 49933 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Hôpital du Nord - Marseille MARSEILLE CEDEX 20, France, 13915 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Hôpital de la Pitié-Salpétrière PARIS, France, 75013 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat, Spain, 08907 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Universitätsklinikum Schleswig-Holstein (UKSH) Kiel, Germany, 24105 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Klinikum der Universität München Grosshadern München, Germany, 81377 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. Milano, Italy, 20089 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Hôpital Civil - Strasbourg STRASBOURG, France, 67091 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Bristol Royal Infirmary Bristol, United Kingdom, BS2 8HW | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations University Hospital of Wales Cardiff, United Kingdom, CF14 4XW | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Royal Liverpool University Hospital Liverpool, United Kingdom, L7 8XP | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Sci-Res. Institute of Emergency Care n.a. N.V. Sklifosovsky Moscow, Russia, 129090 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations First City Clinical Hospital n.a. E.E. Volosevich Arkhangelsk, Russia, 163001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Altai Regional Clinical Hospital Barnaul, Russia, 656024 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Regional Clinical Hospital Krasnoyarsk Krasnoyarsk, Russia, 660022 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Kemerovo Regional Clinical Hospital Kemerovo, Russia, 650066 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Kuban State Medical University Krasnodar, Russia, 350072 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Guy’s Hospital London, United Kingdom, SE1 9RT | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Landesklinikum Krems Krems, Austria, 3500 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations General Hospital of Athens "Evangelismos" Athens, Greece, 10676 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations University General Hospital ATTIKON Chaidari, Greece, 12462 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations SOTIRIA General Hospital of Chest Diseases Athens, Greece, 11527 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations University General Hospital of Heraklion Heraklion / Crete, Greece, 71110 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations General Hospital of Larissa Larissa, Greece, 41110 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Ziekenhuis Gelderse Vallei Ede, Netherlands, 6716 RP | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Medisch Spectrum Twente ENSCHEDE, Netherlands, 7512 KZ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Jeroen Bosch Ziekenhuis DEN BOSCH, Netherlands, 5223 GZ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Ikazia Ziekenhuis ROTTERDAM, Netherlands, 3083 AN | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Canisius Wilhelmina Ziekenhuis NIJMEGEN, Netherlands, 6532 SZ | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Clinique Saint-Pierre OTTIGNIES, Belgium, 1340 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Hôpital Erasme/Erasmus Ziekenhuis BRUXELLES - BRUSSEL, Belgium, 1070 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations CHU UCL Namur | Intensive Care Yvoir, Belgium, 5530 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Tel-Aviv Sourasky Medical Center Tel Aviv, Israel, 6423906 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Soroka University Medical Center Beer Sheva, Israel, 8410101 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Shaare Zedek Medical Center Jerusalem, Israel, 9103102 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Clalit Health Services Rabin Medical Center-Beilinson Campus Petach Tikva, Israel, 4941492 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Vancouver Island Health Authority - Royal Jubilee Hospital Victoria, Canada, V8R 1J8 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Kingston Health Sciences Centre (KGH Site) Kingston, Canada, K7L 2V7 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Toronto General Hospital UHN Toronto, Canada, M5G 2N2 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations North York General Hospital Toronto, Canada, M2K 1E1 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Sunnybrook Health Sciences Centre Toronto, Canada, M4N 3M5 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations CIUSSS de l’Est-de-l’Ile de Montreal,Installation Maisonneuv Montreal, Canada, H1T 2M4 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Centre intégré universitaire du Nord de l'île de Montréal- H Montréal, Canada, H4J 1C5 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations St. Paul's Hospital - Vancouver Vancouver, Canada, V6Z 1Y6 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Universitätsklinikum Essen Essen, Germany, 45147 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 100 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung, Taiwan, China, 807 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Derriford Hospital Plymouth, United Kingdom, PL6 8DH | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations St Vincents University Hospital Dublin, Ireland, DUBLIN 4 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Asan Medical Center Seoul, South Korea, 05505 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Seoul National University Bundang Hospital Seongnam-si, South Korea, 13620 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 03722 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Ajou University Hospital Suwon, South Korea, 443-721 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Pulmonary & Critical Care Seoul National University Boramae Seoul, South Korea, 07061 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations St James' Hospital Dublin, Ireland, D08 NHY1 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Aalborg Universitetshospital, Anesthesiology dept. Aalborg, Denmark, 9000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Sjællands Universitetshospital Køge - Anesthesiological Dept Køge, Denmark, 4600 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Hôpital Cantonal Universitaire de Genève Genève, Switzerland, 1205 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations UniversitätsSpital Zürich Zürich, Switzerland, 8091 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Beaumont Hospital Dublin, Ireland, 9 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations University College Hospital Galway Galway, Ireland | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Royal Victoria Hospital Belfast, United Kingdom, BT12 6BA | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Wythenshawe Hospital Manchester, United Kingdom, M23 9LT | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Spitalul Clinic Judetean de Urgenta „Pius Brinzeu” Timisoara Timisoara, Romania | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Sp. Univ. de Urgenta Militar Central Dr. Carol Davila Bucuresti, Romania, 010825 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Institutul Clinic Fundeni Bucuresti, Romania, 22328 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Spitalul Universitar de Urgenta Elias Bucharest, Romania, 11461 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Magyar Honvedseg Egeszsegugyi Kozpont Budapest, Hungary, 1134 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Fakultna Nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica, Slovakia, 975 17 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations CHVNGE - Hospital Eduardo Santos Silva Vila Nova de Gaia, Portugal, 4434-502 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Hospital da Luz - Lisboa Lisboa, Portugal, 1500-650 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Nemocnica AGEL Zvolen, a.s. Zvolen, Slovakia, 960 01 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations HUS, Meilahden sairaala Helsinki, Finland, 00290 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Tampereen yliopistollinen sairaala, keskussairaala Tampere, Finland, 33520 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Kuopion yliopistollinen sairaala Kuopio, Finland, 70210 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Bata Hospital Zlin, Czech Republic, 762 75 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Fakultni nemocnice u sv. Anny Brno, Czech Republic, 656 91 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 | |
Locations Ospedale regionale di Lugano Lugano, Switzerland, 6900 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Safety and efficacy of inhaled pegylated adrenomedullin (PEG-ADM) in patients suffering from Acute Respiratory Distress Syndrome (ARDS): a double-blind, randomized, placebo-controlled, multicenter Phase 2a/b clinical trial
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
5
Primary Outcome
- VFS in Part B participantsVentilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)Timeframe: At Day 28
Secondary Outcome
- CUI in Part A participantsClinical Utility Index (CUI) is a summary measure used to compare different treatments, the index score will range between 0 and 1.Timeframe: Up to 7 days
- VFS in Part A participantsVentilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)Timeframe: At Day 28
- All-cause mortality in Part A and Part B participantsTimeframe: At Day 28, Day 60 and Day 90
- Proportion of participants who still require invasive mechanical ventilation support in Part A and Part B participantsTimeframe: At Day 28 and Day 60
- Ventilator-free days (VFDs) in Part A and Part B participantsTimeframe: Within Day 28 and Day 60
- VFS in Part A and Part B participantsVentilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)Timeframe: At Day 60
- Integrated analysis on VFS invoving all participants from Part A and Part BVentilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)Timeframe: At Day 28 and Day 60
Additional Information
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