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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04417036
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 21, 2022
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Drug: BAY1097761 Active Dose 1 Other: Placebo to BAY1097761 Drug: BAY1097761 Active Dose 2 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 466 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 7, 2020
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. VFS in Part B participants [ Time Frame: At Day 28 ]
    Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)


Secondary Outcome Measures :
  1. 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.

  2. VFS in Part A participants [ Time Frame: At Day 28 ]
    Ventilator-free survival (VFS, participants alive and not on invasive mechanical ventilation)

  3. All-cause mortality in Part A and Part B participants [ Time Frame: At Day 28, Day 60 and Day 90 ]
  4. 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 ]
  5. Ventilator-free days (VFDs) in Part A and Part B participants [ Time Frame: Within Day 28 and Day 60 ]
  6. 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)

  7. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417036


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
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Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04417036    
Other Study ID Numbers: 19999
2019-001078-27 ( EudraCT Number )
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.


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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
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury