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

EU CT Number:

Not Available

Terminated/Withdrawn

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
90
Trial Dates
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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
Completed
Locations

Fakultni nemocnice Kralovske Vinohrady

Praha 10, Czech Republic, 10034

Status
Completed
Locations

Masaryk Hospital Usti n/L

Usti nad Labem, Czech Republic, 401 13

Status
Completed
Locations

Fakultni nemocnice v Motole

Praha 5, Czech Republic, 150 06

Status
Completed
Locations

Medizinische Universität Innsbruck

Innsbruck, Austria, 6020

Status
Completed
Locations

Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim

Köln, Germany, 51109

Status
Completed
Locations

Klinikum Oldenburg AöR

Oldenburg, Germany, 26133

Status
Completed
Locations

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08041

Status
Completed
Locations

Corporació Sanitària Parc Taulí

Sabadell, Spain, 08208

Status
Completed
Locations

Ciutat Sanitaria i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Completed
Locations

ASST Santi Paolo e Carlo

Milano, Italy, 20142

Status
Completed
Locations

Cochin - Paris

PARIS, France, 75014

Status
Completed
Locations

Center Hospitalier Michallon - Grenoble

LA TRONCHE, France, 38700

Status
Completed
Locations

Centre Hospitalier Universitaire - Angers

ANGERS CEDEX 09, France, 49933

Status
Completed
Locations

Hôpital du Nord - Marseille

MARSEILLE CEDEX 20, France, 13915

Status
Completed
Locations

Hôpital de la Pitié-Salpétrière

PARIS, France, 75013

Status
Completed
Locations

Universitätsklinikum Schleswig-Holstein (UKSH)

Kiel, Germany, 24105

Status
Completed
Locations

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

Milano, Italy, 20089

Status
Completed
Locations

Hôpital Civil - Strasbourg

STRASBOURG, France, 67091

Status
Completed
Locations

University Hospital of Wales

Cardiff, United Kingdom, CF14 4XW

Status
Completed
Locations

Guy’s Hospital

London, United Kingdom, SE1 9RT

Status
Completed

Trial Design