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)

Bayer Identifier:

19999

ClinicalTrials.gov Identifier:

NCT04417036

EudraCT Number:

2019-001078-27

Recruiting

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
466
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
BAY1097761
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Recruiting
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Not yet recruiting
 
Locations

Fakultni nemocnice Kralovske Vinohrady

Praha, Czech Republic, 10034

Status
Recruiting
 
Locations

Masaryk Hospital Usti n/L

Usti nad Labem, Czech Republic, 401 13

Status
Recruiting
 
Locations

Fakultni nemocnice v Motole

Praha 5, Czech Republic, 150 06

Status
Recruiting
 
Locations

Medizinische Universität Innsbruck

Innsbruck, Austria, 6020

Status
Recruiting
 
Locations

Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim

Köln, Germany, 51109

Status
Recruiting
 
Locations

Klinikum Oldenburg AöR

Oldenburg, Germany, 26133

Status
Recruiting
 
Locations

Medizinische Hochschule Hannover (MHH)

Hannover, Germany, 30625

Status
Not yet recruiting
 
Locations

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08041

Status
Recruiting
 
Locations

Corporació Sanitària Parc Taulí

Sabadell, Spain, 08208

Status
Recruiting
 
Locations

Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Recruiting
 
Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Recruiting
 
Locations

ASST Santi Paolo e Carlo

Milano, Italy, 20142

Status
Recruiting
 
Locations

Cochin - Paris

PARIS, France, 75014

Status
Recruiting
 
Locations

Center Hospitalier Michallon - Grenoble

LA TRONCHE, France, 38700

Status
Recruiting
 
Locations

Charité - Universitätsmedizin Berlin

Berlin, Germany, 10117

Status
Not yet recruiting
 
Locations

Centre Hospitalier Universitaire - Angers

ANGERS CEDEX 09, France, 49933

Status
Recruiting
 
Locations

Hôpital du Nord - Marseille

MARSEILLE CEDEX 20, France, 13915

Status
Recruiting
 
Locations

Hôpital de la Pitié-Salpétrière

PARIS, France, 75013

Status
Recruiting
 
Locations

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Status
Not yet recruiting
 
Locations

Universitätsklinikum Schleswig-Holstein (UKSH)

Kiel, Germany, 24105

Status
Recruiting
 
Locations

Klinikum der Universität München Grosshadern

München, Germany, 81377

Status
Not yet recruiting
 
Locations

Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

Milano, Italy, 20089

Status
Completed
 
Locations

Hôpital Civil - Strasbourg

STRASBOURG, France, 67091

Status
Recruiting
 
Locations

Bristol Royal Infirmary

Bristol, United Kingdom, BS2 8HW

Status
Not yet recruiting
 
Locations

University Hospital of Wales

Cardiff, United Kingdom, CF14 4XW

Status
Recruiting
 
Locations

Royal Liverpool University Hospital

Liverpool, United Kingdom, L7 8XP

Status
Not yet recruiting
 
Locations

Sci-Res. Institute of Emergency Care n.a. N.V. Sklifosovsky

Moscow, Russia, 129090

Status
Not yet recruiting
 
Locations

First City Clinical Hospital n.a. E.E. Volosevich

Arkhangelsk, Russia, 163001

Status
Not yet recruiting
 
Locations

Altai Regional Clinical Hospital

Barnaul, Russia, 656024

Status
Not yet recruiting
 
Locations

Regional Clinical Hospital Krasnoyarsk

Krasnoyarsk, Russia, 660022

Status
Not yet recruiting
 
Locations

Kemerovo Regional Clinical Hospital

Kemerovo, Russia, 650066

Status
Not yet recruiting
 
Locations

Kuban State Medical University

Krasnodar, Russia, 350072

Status
Not yet recruiting
 
Locations

Guy’s Hospital

London, United Kingdom, SE1 9RT

Status
Recruiting
 
Locations

Landesklinikum Krems

Krems, Austria, 3500

Status
Not yet recruiting
 
Locations

General Hospital of Athens "Evangelismos"

Athens, Greece, 10676

Status
Not yet recruiting
 
Locations

University General Hospital ATTIKON

Chaidari, Greece, 12462

Status
Not yet recruiting
 
Locations

SOTIRIA General Hospital of Chest Diseases

Athens, Greece, 11527

Status
Not yet recruiting
 
Locations

University General Hospital of Heraklion

Heraklion / Crete, Greece, 71110

Status
Not yet recruiting
 
Locations

General Hospital of Larissa

Larissa, Greece, 41110

Status
Not yet recruiting
 
Locations

Ziekenhuis Gelderse Vallei

Ede, Netherlands, 6716 RP

Status
Not yet recruiting
 
Locations

Medisch Spectrum Twente

ENSCHEDE, Netherlands, 7512 KZ

Status
Not yet recruiting
 
Locations

Jeroen Bosch Ziekenhuis

DEN BOSCH, Netherlands, 5223 GZ

Status
Not yet recruiting
 
Locations

Ikazia Ziekenhuis

ROTTERDAM, Netherlands, 3083 AN

Status
Not yet recruiting
 
Locations

Canisius Wilhelmina Ziekenhuis

NIJMEGEN, Netherlands, 6532 SZ

Status
Not yet recruiting
 
Locations

Clinique Saint-Pierre

OTTIGNIES, Belgium, 1340

Status
Not yet recruiting
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Not yet recruiting
 
Locations

CHU UCL Namur | Intensive Care

Yvoir, Belgium, 5530

Status
Not yet recruiting
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Not yet recruiting
 
Locations

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906

Status
Not yet recruiting
 
Locations

Rambam Health Corporation

Haifa, Israel, 3109601

Status
Not yet recruiting
 
Locations

Soroka University Medical Center

Beer Sheva, Israel, 8410101

Status
Not yet recruiting
 
Locations

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Status
Not yet recruiting
 
Locations

Clalit Health Services Rabin Medical Center-Beilinson Campus

Petach Tikva, Israel, 4941492

Status
Not yet recruiting
 
Locations

Vancouver Island Health Authority - Royal Jubilee Hospital

Victoria, Canada, V8R 1J8

Status
Not yet recruiting
 
Locations

Kingston Health Sciences Centre (KGH Site)

Kingston, Canada, K7L 2V7

Status
Not yet recruiting
 
Locations

Toronto General Hospital UHN

Toronto, Canada, M5G 2N2

Status
Not yet recruiting
 
Locations

North York General Hospital

Toronto, Canada, M2K 1E1

Status
Not yet recruiting
 
Locations

Sunnybrook Health Sciences Centre

Toronto, Canada, M4N 3M5

Status
Not yet recruiting
 
Locations

CIUSSS de l’Est-de-l’Ile de Montreal,Installation Maisonneuv

Montreal, Canada, H1T 2M4

Status
Not yet recruiting
 
Locations

Centre intégré universitaire du Nord de l'île de Montréal- H

Montréal, Canada, H4J 1C5

Status
Not yet recruiting
 
Locations

St. Paul's Hospital - Vancouver

Vancouver, Canada, V6Z 1Y6

Status
Not yet recruiting
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45147

Status
Not yet recruiting
 
Locations

National Taiwan University Hospital

Taipei, Taiwan, China, 100

Status
Not yet recruiting
 
Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, China, 807

Status
Not yet recruiting
 
Locations

Derriford Hospital

Plymouth, United Kingdom, PL6 8DH

Status
Not yet recruiting
 
Locations

Taichung Veterans General Hospital

Taichung, Taiwan, China, 40705

Status
Not yet recruiting
 
Locations

Taipei Veterans General Hospital

Taipei, Taiwan, China, 11217

Status
Not yet recruiting
 
Locations

St Vincents University Hospital

Dublin, Ireland, DUBLIN 4

Status
Not yet recruiting
 
Locations

Asan Medical Center

Seoul, South Korea, 05505

Status
Not yet recruiting
 
Locations

Seoul National University Bundang Hospital

Seongnam-si, South Korea, 13620

Status
Not yet recruiting
 
Locations

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Status
Not yet recruiting
 
Locations

Ajou University Hospital

Suwon, South Korea, 443-721

Status
Not yet recruiting
 
Locations

Pulmonary & Critical Care Seoul National University Boramae

Seoul, South Korea, 07061

Status
Not yet recruiting
 
Locations

St James' Hospital

Dublin, Ireland, D08 NHY1

Status
Not yet recruiting
 
Locations

Aalborg Universitetshospital, Anesthesiology dept.

Aalborg, Denmark, 9000

Status
Not yet recruiting
 
Locations

Sjællands Universitetshospital Køge - Anesthesiological Dept

Køge, Denmark, 4600

Status
Not yet recruiting
 
Locations

Hôpital Cantonal Universitaire de Genève

Genève, Switzerland, 1205

Status
Not yet recruiting
 
Locations

UniversitätsSpital Zürich

Zürich, Switzerland, 8091

Status
Not yet recruiting
 
Locations

Beaumont Hospital

Dublin, Ireland, 9

Status
Not yet recruiting
 
Locations

University College Hospital Galway

Galway, Ireland

Status
Not yet recruiting
 
Locations

Royal Victoria Hospital

Belfast, United Kingdom, BT12 6BA

Status
Not yet recruiting
 
Locations

Wythenshawe Hospital

Manchester, United Kingdom, M23 9LT

Status
Not yet recruiting
 
Locations

Spitalul Clinic Judetean de Urgenta „Pius Brinzeu” Timisoara

Timisoara, Romania

Status
Not yet recruiting
 
Locations

Sp. Univ. de Urgenta Militar Central Dr. Carol Davila

Bucuresti, Romania, 010825

Status
Not yet recruiting
 
Locations

Institutul Clinic Fundeni

Bucuresti, Romania, 22328

Status
Not yet recruiting
 
Locations

Spitalul Universitar de Urgenta Elias

Bucharest, Romania, 11461

Status
Not yet recruiting
 
Locations

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, Hungary, 1134

Status
Not yet recruiting
 
Locations

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

Status
Not yet recruiting
 
Locations

Fakultna Nemocnica s poliklinikou F.D.Roosevelta

Banska Bystrica, Slovakia, 975 17

Status
Not yet recruiting
 
Locations

CHVNGE - Hospital Eduardo Santos Silva

Vila Nova de Gaia, Portugal, 4434-502

Status
Not yet recruiting
 
Locations

Hospital da Luz - Lisboa

Lisboa, Portugal, 1500-650

Status
Not yet recruiting
 
Locations

Nemocnica AGEL Zvolen, a.s.

Zvolen, Slovakia, 960 01

Status
Not yet recruiting
 
Locations

HUS, Meilahden sairaala

Helsinki, Finland, 00290

Status
Not yet recruiting
 
Locations

Tampereen yliopistollinen sairaala, keskussairaala

Tampere, Finland, 33520

Status
Not yet recruiting
 
Locations

Kuopion yliopistollinen sairaala

Kuopio, Finland, 70210

Status
Not yet recruiting
 
Locations

Bata Hospital

Zlin, Czech Republic, 762 75

Status
Not yet recruiting
 
Locations

Fakultni nemocnice u sv. Anny

Brno, Czech Republic, 656 91

Status
Not yet recruiting
 
Locations

Ospedale regionale di Lugano

Lugano, Switzerland, 6900

Status
Not yet recruiting
 

Trial Design