Status:
TERMINATED
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)
Lead Sponsor:
Bayer
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ther...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04417036
Start Date
July 7 2020
End Date
December 28 2022
Last Update
April 18 2023
Active Locations (22)
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1
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria, 6020
2
Universitätsklinikum AKH Wien
Vienna, Austria, 1090
3
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia, 10034
4
Fakultni nemocnice v Motole
Prague, Czechia, 150 06