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)

NCT ID: NCT04609943

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-24
• Study Completion Date: 2023-09-14

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)

Conditions

Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BAY1211163

Adult patients with moderate or severe Acute Respiratory Distress Syndrome (ARDS) diagnosis before study inclusion will receive BAY1211163.

Group Type: EXPERIMENTAL

BAY1211163

Intervention Type: DRUG

Participants will receive one of the drug doses of BAY1211163 solution three times per day (TID) by inhalation for seven days.

Interventions

BAY1211163

Participants will receive one of the drug doses of BAY1211163 solution three times per day (TID) by inhalation for seven days.

Intervention Type: DRUG

Eligibility 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.
• 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 already initiated at screening and/or Day 1.
• Use of co-medications involving moderate and strong inhibitors for CYP2C8 liver enzymes one week before assignment to intervention or during intervention.
• Off-label use of medication to treat Coronavirus SARS-CoV-2 virus unless recommended by scientific guidelines and accepted by DMC, investigator and sponsor.
• Plan to participate or past participation (within 30 days prior to Study Day 1) in other interventional studies.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinikum Giessen und Marburg

Giessen, Hesse, Germany

Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim

Cologne, North Rhine-Westphalia, Germany

Sana-Klinikum Remscheid|Kardio, Angio, Pneumo u. Intensivmed

Remscheid, North Rhine-Westphalia, Germany

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

Related Links

https://clinicaltrials.bayer.com/study/20425

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.

Other Identifiers

2019-004950-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20425

Identifier Type: -

Identifier Source: org_study_id