Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT05241067
Eligibility Criteria:
Inclusion Criteria:
A subject will be eligible for inclusion in the study if he/she fulfills the following criteria:
1. Adult male or female aged 18 years or older
2. Hospitalized in the ICU diagnosed with moderate to severe ARDS having a PaO2/FiO2 ratio of \< 200 mmHg or the SPO2/FiO2 ratio of ≤ 235( if SPO2 ≤ 97 %) with PEEP ≥ 5 cm H20 include the patient receiving invasive /non-invasive ventilation (NIV/CPAP).
3. The first dose of the study drug should be administered within 48 hours of confirming moderate to severe ARDS.
4. Requires vasopressor support
5. Written informed consent
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if he/she meets any of the following exclusion criteria:
1. Receiving or expected to receive extracorporeal membrane oxygenation or high-frequency oscillatory ventilation
2. Confirmed pregnancy
3. Breast feeding
4. Participating in another interventional study
5. Requires or having the renal replacement therapy
6. Hepatic failure (Child-Pugh scores B and C)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05241067
Study Brief:
Protocol Section:
NCT05241067