stop_circleTerminated/Withdrawn
Acute respiratory distress syndrome
Bayer Identifier:
19999
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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)
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
90Trial Dates
July 2020 - December 2022Phase
Phase 2Could I Receive a placebo
YesProducts
BAY1097761Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Withdrawn | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | Fakultni nemocnice Kralovske Vinohrady | Praha 10, 10034, Czechia |
Completed | Masaryk Hospital Usti n/L | Usti nad Labem, 401 13, Czechia |
Completed | Fakultni nemocnice v Motole | Praha 5, 150 06, Czechia |
Withdrawn | Kepler Universitätsklinikum Campus III | Linz, 4020, Austria |
Completed | Medizinische Universität Innsbruck | Innsbruck, 6020, Austria |
Completed | Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim | Köln, 51109, Germany |
Completed | Klinikum Oldenburg AöR | Oldenburg, 26133, Germany |
Withdrawn | Medizinische Hochschule Hannover (MHH) | Hannover, 30625, Germany |
Completed | Hospital de la Santa Creu i de Sant Pau | Barcelona, 08041, Spain |
Completed | Corporació Sanitària Parc Taulí | Sabadell, 08208, Spain |
Completed | Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Completed | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano, 20122, Italy |
Completed | ASST Santi Paolo e Carlo | Milano, 20142, Italy |
Completed | Cochin - Paris | PARIS, 75014, France |
Completed | Center Hospitalier Michallon - Grenoble | LA TRONCHE, 38700, France |
Withdrawn | Charité - Universitätsmedizin Berlin | Berlin, 10117, Germany |
Completed | Centre Hospitalier Universitaire - Angers | ANGERS CEDEX 09, 49933, France |
Completed | Hôpital du Nord - Marseille | MARSEILLE CEDEX 20, 13915, France |
Withdrawn | Hospital Universitario de Getafe | Getafe, 28905, Spain |
Completed | Hôpital de la Pitié-Salpétrière | PARIS, 75013, France |
Withdrawn | ASST di Monza | Monza Brianza, 20090, Italy |
Withdrawn | Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention | L'Hospitalet de Llobregat, 08907, Spain |
Completed | Universitätsklinikum Schleswig-Holstein (UKSH) | Kiel, 24105, Germany |
Withdrawn | Klinikum der Universität München Grosshadern | München, 81377, Germany |
Completed | Istituto Clinico Humanitas - Humanitas Mirasole S.p.A. | Milano, 20089, Italy |
Completed | Hôpital Civil - Strasbourg | STRASBOURG, 67091, France |
Withdrawn | Bristol Royal Infirmary | Bristol, BS2 8HW, United Kingdom |
Completed | University Hospital of Wales | Cardiff, CF14 4XW, United Kingdom |
Withdrawn | Royal Liverpool University Hospital | Liverpool, L7 8XP, United Kingdom |
Withdrawn | Sci-Res. Institute of Emergency Care n.a. N.V. Sklifosovsky | Moscow, 129090, Russian Federation |
Withdrawn | First City Clinical Hospital n.a. E.E. Volosevich | Arkhangelsk, 163001, Russian Federation |
Withdrawn | Altai Regional Clinical Hospital | Barnaul, 656024, Russian Federation |
Withdrawn | Regional Clinical Hospital Krasnoyarsk | Krasnoyarsk, 660022, Russian Federation |
Withdrawn | Kemerovo Regional Clinical Hospital | Kemerovo, 650066, Russian Federation |
Withdrawn | Kuban State Medical University | Krasnodar, 350072, Russian Federation |
Completed | Guy’s Hospital | London, SE1 9RT, United Kingdom |
Withdrawn | Landesklinikum Krems | Krems, 3500, Austria |
Withdrawn | General Hospital of Athens "Evangelismos" | Athens, 10676, Greece |
Withdrawn | University General Hospital ATTIKON | Chaidari, 12462, Greece |
Withdrawn | SOTIRIA General Hospital of Chest Diseases | Athens, 11527, Greece |
Withdrawn | University General Hospital of Heraklion | Heraklion / Crete, 71110, Greece |
Withdrawn | General Hospital of Larissa | Larissa, 41110, Greece |
Withdrawn | Ziekenhuis Gelderse Vallei | Ede, 6716 RP, Netherlands |
Withdrawn | Medisch Spectrum Twente | ENSCHEDE, 7512 KZ, Netherlands |
Withdrawn | Jeroen Bosch Ziekenhuis | DEN BOSCH, 5223 GZ, Netherlands |
Withdrawn | Ikazia Ziekenhuis | ROTTERDAM, 3083 AN, Netherlands |
Withdrawn | Canisius Wilhelmina Ziekenhuis | NIJMEGEN, 6532 SZ, Netherlands |
Withdrawn | Clinique Saint-Pierre | OTTIGNIES, 1340, Belgium |
Withdrawn | Hôpital Erasme/Erasmus Ziekenhuis | BRUXELLES - BRUSSEL, 1070, Belgium |
Withdrawn | CHU UCL Namur | Intensive Care | Yvoir, 5530, Belgium |
Withdrawn | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Withdrawn | Tel-Aviv Sourasky Medical Center | Tel Aviv, 6423906, Israel |
Withdrawn | Rambam Health Corporation | Haifa, 3109601, Israel |
Withdrawn | Soroka University Medical Center | Beer Sheva, 8410101, Israel |
Withdrawn | Shaare Zedek Medical Center | Jerusalem, 9103102, Israel |
Withdrawn | Clalit Health Services Rabin Medical Center-Beilinson Campus | Petach Tikva, 4941492, Israel |
Withdrawn | Vancouver Island Health Authority - Royal Jubilee Hospital | Victoria, V8R 1J8, Canada |
Withdrawn | Kingston Health Sciences Centre (KGH Site) | Kingston, K7L 2V7, Canada |
Withdrawn | Toronto General Hospital UHN | Toronto, M5G 2N2, Canada |
Withdrawn | North York General Hospital | Toronto, M2K 1E1, Canada |
Withdrawn | Sunnybrook Health Sciences Centre | Toronto, M4N 3M5, Canada |
Withdrawn | CIUSSS de l’Est-de-l’Ile de Montreal,Installation Maisonneuv | Montreal, H1T 2M4, Canada |
Withdrawn | Centre intégré universitaire du Nord de l'île de Montréal- H | Montréal, H4J 1C5, Canada |
Withdrawn | St. Paul's Hospital - Vancouver | Vancouver, V6Z 1Y6, Canada |
Withdrawn | Universitätsklinikum Essen | Essen, 45147, Germany |
Withdrawn | National Taiwan University Hospital | Taipei, 100, Taiwan |
Withdrawn | Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung, 807, Taiwan |
Withdrawn | Derriford Hospital | Plymouth, PL6 8DH, United Kingdom |
Withdrawn | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Withdrawn | Taipei Veterans General Hospital | Taipei, 11217, Taiwan |
Withdrawn | St Vincents University Hospital | Dublin, DUBLIN 4, Ireland |
Withdrawn | Asan Medical Center | Seoul, 05505, Korea, Republic Of |
Withdrawn | Seoul National University Bundang Hospital | Seongnam-si, 13620, Korea, Republic Of |
Withdrawn | Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea, Republic Of |
Withdrawn | Ajou University Hospital | Suwon, 443-721, Korea, Republic Of |
Withdrawn | Pulmonary & Critical Care Seoul National University Boramae | Seoul, 07061, Korea, Republic Of |
Withdrawn | St James' Hospital | Dublin, D08 NHY1, Ireland |
Withdrawn | Aalborg Universitetshospital, Anesthesiology dept. | Aalborg, 9000, Denmark |
Withdrawn | Sjællands Universitetshospital Køge - Anesthesiological Dept | Køge, 4600, Denmark |
Withdrawn | Hôpital Cantonal Universitaire de Genève | Genève, 1205, Switzerland |
Withdrawn | UniversitätsSpital Zürich | Zürich, 8091, Switzerland |
Withdrawn | Beaumont Hospital | Dublin, 9, Ireland |
Withdrawn | University College Hospital Galway | Galway, Ireland |
Withdrawn | Taunton and Somerset Hospital | Taunton, TA1 5DA, United Kingdom |
Withdrawn | Royal Victoria Hospital | Belfast, BT12 6BA, United Kingdom |
Withdrawn | Wythenshawe Hospital | Manchester, M23 9LT, United Kingdom |
Withdrawn | Spitalul Clinic Judetean de Urgenta „Pius Brinzeu” Timisoara | Timisoara, Romania |
Withdrawn | Sp. Univ. de Urgenta Militar Central Dr. Carol Davila | Bucuresti, 010825, Romania |
Withdrawn | Institutul Clinic Fundeni | Bucuresti, 22328, Romania |
Withdrawn | Spitalul Universitar de Urgenta Elias | Bucharest, 11461, Romania |
Withdrawn | Eszak-Pesti Centrumkorhaz-Honvedkorhaz | Budapest, 1134, Hungary |
Withdrawn | Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary |
Withdrawn | Fakultna Nemocnica s poliklinikou F.D.Roosevelta | Banska Bystrica, 975 17, Slovakia |
Withdrawn | Centro Hospitalar Vila Nova de Gaia/Espinho | Unit 1 - Clinical Research Office | Porto, 4434-502, Portugal |
Withdrawn | Hospital da Luz - Lisboa | Lisboa, 1500-650, Portugal |
Withdrawn | Nemocnica AGEL Zvolen, a.s. | Zvolen, 960 01, Slovakia |
Withdrawn | HUS, Meilahden sairaala | Helsinki, 00290, Finland |
Withdrawn | Tampereen yliopistollinen sairaala, keskussairaala | Tampere, 33520, Finland |
Withdrawn | Kuopion yliopistollinen sairaala | Kuopio, 70210, Finland |
Withdrawn | Bata Hospital | Zlin, 762 75, Czechia |
Withdrawn | Fakultni nemocnice u sv. Anny | Brno, 656 91, Czechia |
Withdrawn | Ospedale regionale di Lugano | Lugano, 6900, Switzerland |
Primary Outcome
- VFS in Part B participantsVentilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)date_rangeTime Frame: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.date_rangeTime Frame:Up to 7 days
- VFS in Part A participantsVentilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)date_rangeTime Frame:At Day 28
- All-cause mortality in Part A and Part B participantsdate_rangeTime 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 participantsdate_rangeTime Frame:At Day 28 and Day 60
- Ventilator-free days (VFDs) in Part A and Part B participantsdate_rangeTime Frame: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)date_rangeTime Frame: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)date_rangeTime Frame:At Day 28 and Day 60
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
5