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 @ 6:39 PM
Ignite Modification Date:
2025-12-24 @ 6:39 PM
NCT ID:
NCT04357457
Eligibility Criteria:
Inclusion Criteria:
* Adults patients aged 80 years or less
* COVID-19 diagnosis defined as either positive RT-PCR for SARS-CoV-2 or COVID-19 compatible or typical chest CT pattern or positive serology for COVID-19 antibodies
* Hypoxemic acute respiratory failure with the following criteria: oxygen saturation level of 92% or less, as measured by pulsed oximetry (SpO2) under oxygen therapy with an oxygen rate of 6L/min or more.
* Hospital admission for COVID-19 within 14 days
* Patients affiliated
Exclusion Criteria:
* Hypersensitivity to the active substance or to any of the excipients
* Pregnancy or breastfeeding woman
* Known Hepatic failure (PT \<50%, Factor V \< 50%)
* Last known Plasma total bilirubin \> 21 μmol/L
* Lactate level \> 4 mmol/L
* ALT and AST levels greater than 3 times the upper limit
* Pulmonary hypertension (PAPs ≥37 mmHG and/or VmaxIT ≥ 2,9 m/s) or right ventricular dysfunction
* History of pulmonary embolism
* Diagnosis of pulmonary embolism during the current hospitalization or on-going anticoagulant therapy at curative dose for thromboembolism when hospitalized
* PaCO2 \> 45 mmHg
* Exacerbation of asthma or chronic respiratory failure
* Cardiogenic pulmonary oedema
* Systolic blood pressure of 90 mmHg or less, or use of vasopressors
* Urgent need for endotracheal intubation at the discretion of the treating physician
* Do-not-intubate order or estimated life expectancy less than 6 months
* Participation in another interventional research
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04357457
Study Brief:
Protocol Section:
NCT04357457