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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) | Clinical Trials | Clareo Health

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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)

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

NCT04609943•Bayer

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

Locations (4)

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

Key Dates

Start Date

November 24, 2020

Primary Completion Date

August 17, 2023

Completion Date

September 14, 2023

Last Updated

September 19, 2024

Enrollment

ACTUAL participants

Conditions

Acute Respiratory Distress Syndrome

Interventions

BAY1211163

DRUG

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome

NCT07450846

Acute Respiratory Distress SyndromeRight Heart Failure

View study

RECRUITING

Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation

NCT07414056

Acute Respiratory Distress Syndrome (ARDS)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

Incidence and Evolution of Heart-lung Interaction in Acute Respiratory Distress Syndrome

Turning Ratios Into Prognosis: Neutrophil-to-Lymphocyte and Platelet-to-Lymphocyte Ratios as Powerful Predictors of ARDS in Pediatric Burn Patients: A Prospective Evaluation

JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

Assessment of Airway Opening Pressure in Invasively Ventilated Children

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