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Study to Find the Highest Safe Dose of Soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 Administered as Multiple Doses by Inhalation to Patients Who Cannot Breathe by Their Own and Suffer From a Type of Lung Failure That Causes Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)

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: NCT04609943
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
With this study researchers want to find the highest safe dose of the soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 and how safe and well the study drug works. Furthermore researchers want to gather information on the way the body absorbs, distributes and gets rid of the study drug given as increasing multiple doses by inhalation to patients who cannot breathe by their own and suffer from a type of lung failure that causes fluid to build up in the lungs making breathing difficult (ARDS)

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Drug: BAY1211163 Dose 1 Drug: BAY1211163 Dose 2 Drug: BAY1211163 Dose 3 Drug: BAY1211163 Dose 4 Drug: BAY1211163 Dose 5 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Tolerability of Adaptive Escalating Multiple Doses (Three Times Daily) of a Soluble Guanylate Cyclase (sGC) Activator Inhale, BAY 1211163, as Inhalation in Intubated and Mechanically Ventilated Adult Patients With Moderate and Severe Acute Respiratory Distress Syndrome (ARDS). A Pilot (Phase Ib), First in Patient, Open Label Study
Actual Study Start Date : November 24, 2020
Estimated Primary Completion Date : December 14, 2021
Estimated Study Completion Date : February 18, 2022


Arm Intervention/treatment
Experimental: Drug Dose 1
Adult patients with moderate or severe Acute Respiratory Distress Syndrome (ARDS) diagnosis before study inclusion will receive BAY1211163 Dose 1.
Drug: BAY1211163 Dose 1
Participants will receive BAY1211163 solution Dose 1 three times per day (TID) by inhalation for seven days.

Experimental: Drug Dose 2
Adult patients with moderate or severe Acute Respiratory Distress Syndrome (ARDS) diagnosis before study inclusion will receive BAY1211163 Dose 2.
Drug: BAY1211163 Dose 2
Participants will receive BAY1211163 solution Dose 2 three times per day (TID) by inhalation for seven days.

Experimental: Drug Dose 3
Adult patients with moderate or severe Acute Respiratory Distress Syndrome (ARDS) diagnosis before study inclusion will receive BAY1211163 Dose 3.
Drug: BAY1211163 Dose 3
Participants will receive BAY1211163 solution Dose 3 three times per day (TID) by inhalation for seven days.

Experimental: Drug Dose 4
Adult patients with moderate or severe Acute Respiratory Distress Syndrome (ARDS) diagnosis before study inclusion will receive BAY1211163 Dose 4.
Drug: BAY1211163 Dose 4
Participants will receive BAY1211163 solution Dose 4 three times per day (TID) by inhalation for seven days.

Experimental: Drug Dose 5
Adult patients with moderate or severe Acute Respiratory Distress Syndrome (ARDS) diagnosis before study inclusion will receive BAY1211163 Dose 5.
Drug: BAY1211163 Dose 5
Participants will receive BAY1211163 solution Dose 5 three times per day (TID) by inhalation for seven days.




Primary Outcome Measures :
  1. Numbers of participants with treatment emergent adverse events (TEAEs) [ Time Frame: Up to 9 days ]
  2. Numbers of participants with dose limiting events (DLEs) [ Time Frame: Day 1 to 7 (may include Day 8) ]
    A dose limiting event is defined as any of the TEAEs occurring during dosing with BAY1211163 and regarded by the investigators to be related to BAY1211163.


Secondary Outcome Measures :
  1. Values of oxygenation index (OI) [ Time Frame: Up to 28 days ]
    The Oxygenation Index (OI) is calculated by using the fraction of inspired oxygen (FiO2), the partial pressure of oxygen in arterial blood (PaO2) and the mean airway pressure (MPAW)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Intubated, mechanically ventilated moderate or severe ARDS patients [diagnosed according to Berlin definition of ARDS, including PEEP ≥ 5 cmH2O, X-ray, with PaO2/FiO2 between 80 and 200 mmHg (inclusive).
  • Initial diagnosis of ARDS prior to study inclusion, confirmation of ongoing moderate or severe ARDS with PaO2/FiO2 between 80 and 200 mmHg (inclusive) during this time under maintained invasive mechanical ventilation.
  • Hypoxemia with PaO2/FiO2 between 80 and 200 mmHg (inclusive) maintained for at least 8 hours (recommend to be 12 hours) after screening, despite consent to follow recommendation on ventilator strategy and PEEP management.
  • Time from intubation must be ≤ 96h.
  • Male and non-pregnant female.
  • Informed consent of capable patient or, in case of patient being incapable of giving informed consent, consent for study inclusion will be sought according to applicable laws and regulations.

Exclusion Criteria:

  • PaO2/FiO2 > 200 mmHg or < 80 mmHg at time of evaluation for inclusion.
  • Moribund participants not expected to survive 24 hours (clinical decision).
  • Expected duration of invasive mechanical ventilation less than 96 hours (clinical decision).
  • History of pneumectomy or lung transplant.
  • Current lung malignancy (including lung metastasis), or other malignancy requiring chemotherapy or radiation within the last month.
  • History of chronic kidney disease and requiring renal replacement therapy dialysis at screening and/or baseline.
  • Chronic liver disease Child-Pugh Class B and C.
  • Hypoalbuminemia - serum albumin < 2.0 g/dL (at investigator's discretion and clinical judgement, albumin infusion is allowed).
  • Acute left ventricular failure and/or Left Ventricular Ejection Fraction < 30 %.
  • Severe bronchopulmonal fistula.
  • Clinical suspicion of pulmonary veno-occlusive disease.
  • Heart right-sided endocarditis, tumors or mass.
  • Rescue procedures (e.g.: inhalation of NO gas and/or inhalation of prostacyclin analogues or ECMO/ECCO2R) already initiated at screening and/or Day 1 (prior to first dose of the study intervention).
  • Use of co-medications involving moderate and strong inhibitors for CYP2C8 liver enzymes one week before assignment to intervention or during intervention.
  • Patients under treatment with drugs not approved by local Health Authorities to treat SARS-Cov-2.
  • Plan to participate or past participation (within 30 days prior to Study Day 1) in other interventional studies involving pharmacological interventions, or biological or cell therapy interventions.

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): NCT04609943


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

Locations
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Germany
Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim Recruiting
Köln, Nordrhein-Westfalen, Germany, 51109
Charité - Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 10117
Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04609943    
Other Study ID Numbers: 20425
2019-004950-26 ( EudraCT Number )
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury