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:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
NCT ID:
NCT04333368
Eligibility Criteria:
Inclusion Criteria:
* Male or female patient, age \> 18 years,
* Laboratory (RT-PCR)-confirmed infection with SARS-CoV2
* Diagnosis of ARDS according to the Berlin definition of ARDS
* Under invasive, non-invasive ventilation or high-flow nasal oxygen therapy (PEEP ≥ 5 cmH2O)
* Onset of ARDS \<96 hours
* Patient with French Social Security System
* Provision of a written informed consent by the designated substitute decision maker, if present. In the event of absence, the patient can be included by investigator's decision alone.
Exclusion Criteria:
* Previous history of ARDS in the last month
* Chronic respiratory diseases requiring long-term oxygen therapy and/or long-term respiratory assistance
* Allogeneic bone marrow transplantation
* Active cancer
* Liver cirrhosis with basal Child and Pugh of C
* Pulmonary fibrosis
* Patient with end-of-life decision
* Patient not expected to survive for 24 hours
* Patient who received an organ transplant
* Woman known to be pregnant or lactating
* Patient already enrolled in another interventional pharmacotherapy protocol on COVID-19
* Patient has burns to ≥15% of their total body surface area
* Patient is receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support
* Patient under tutelage
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04333368
Study Brief:
Protocol Section:
NCT04333368