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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT04502433
Eligibility Criteria:
Inclusion Criteria:
Participants were eligible to be included in the study if the following criteria apply:
1. Male or female ≥18 and ≤ 80 years of age
2. Informed consent for participation in the study (refer to section 15 for detailed inform consent procedure)
3. Positive 2019-nCoV Reverse Transcription Polymerase Chain Reaction (rt-PCR) before randomisation
4. Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen (PaO2/FiO2) ratio \< 150 mmHg
5. Lung compliance ≤45 ml/cmH20
6. Intubated and artificially ventilated less than 48 hours before the first poractant alfa administration
Exclusion Criteria:
Participants were excluded from the study if any of the following criteria apply:
1. Any contraindications to surfactant administration e.g., pulmonary hemorrhage and pneumothorax)
2. Weight \< 40kg
3. Stage 4 severe chronic kidney disease (i.e., Estimated Glomerular Filtration Rate (eGFR) \< 30)
4. Pregnancy
5. Administration of any nebulized surfactant in the 48 hours before the first poractant alfa administration
6. Extracorporeal membrane oxygenation (ECMO)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04502433
Study Brief:
Protocol Section:
NCT04502433