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)

April 13, 2023 updated by: Bayer

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Universitätsklinikum AKH Wien
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Medizinische Universität Innsbruck
  • Czechia
      • Praha 10, Czechia, 10034
        • Fakultní Nemocnice Královské Vinohrady
      • Praha 5, Czechia, 150 06
        • Fakultni nemocnice v Motole
      • Usti nad Labem, Czechia, 401 13
        • Masaryk Hospital Usti n/L
  • France
      • Angers Cedex 09, France, 49933
        • Centre Hospitalier Universitaire - Angers
      • La Tronche, France, 38700
        • Center Hospitalier Michallon - Grenoble
      • Marseille Cedex 20, France, 13915
        • Hôpital du Nord - Marseille
      • Paris, France, 75013
        • Hôpital de la Pitié-Salpêtrière
      • Paris, France, 75014
        • Cochin - Paris
      • Strasbourg, France, 67091
        • Hôpital Civil - Strasbourg
  • Germany
    • Niedersachsen
      • Oldenburg, Niedersachsen, Germany, 26133
        • Klinikum Oldenburg AöR
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 51109
        • Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein (UKSH)
  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Milano, Lombardia, Italy, 20142
        • Asst Santi Paolo E Carlo
      • Milano, Lombardia, Italy, 20089
        • Istituto Clinico Humanitas - Humanitas Mirasole S.P.A.
  • Spain
      • Barcelona, Spain, 08035
        • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i de Sant Pau
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • University Hospital of Wales
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A - Active Drug Dose 1
Participants will receive Active Drug Dose 1 for a maximum of 14 days in study phase Part A
Drug: BAY1097761 Active Dose 1
Participants will receive a lower dose ADM by inhalation
Experimental: Part A - Active Drug Dose 2
Participants will receive Active Drug Dose 2 for a maximum of 14 days in study phase Part A
Drug: BAY1097761 Active Dose 2
Participants will receive a higher dose ADM by inhalation
Placebo Comparator: Part A - Placebo
Participants will receive Placebo for a maximum of 14 days in study phase Part A
Other: Placebo to BAY1097761
Participants will receive Placebo to BAY1097761 by inhalation
Experimental: Part B - Active Drug Dose
Participants will receive Active Drug 1 or 2 for a maximum of 14 days in study phase Part B
Drug: BAY1097761 Active Dose 1
Participants will receive a lower dose ADM by inhalation
Drug: BAY1097761 Active Dose 2
Participants will receive a higher dose ADM by inhalation
Placebo Comparator: Part B - Placebo
Participants will receive Placebo for a maximum of 14 days in study phase Part B
Other: Placebo to BAY1097761
Participants will receive Placebo to BAY1097761 by inhalation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
VFS in Part B participants
Time Frame: At Day 28
Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)
At Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
CUI in Part A participants
Time Frame: Up to 7 days
Clinical Utility Index (CUI) is a summary measure used to compare different treatments, the index score will range between 0 and 1.
Up to 7 days
VFS in Part A participants
Time Frame: At Day 28
Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)
At Day 28
All-cause mortality in Part A and Part B participants
Time Frame: At Day 28, Day 60 and Day 90
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
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
Within Day 28 and Day 60
VFS in Part A and Part B participants
Time Frame: At Day 60
Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)
At Day 60
Integrated analysis on VFS invoving all participants from Part A and Part B
Time Frame: At Day 28 and Day 60
Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)
At Day 28 and Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19999
  • 2019-001078-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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