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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT04400032
Eligibility Criteria:
Inclusion Criteria:
* Age of ≥18 years
* Laboratory-confirmed SARS-CoV-2 infection during the current admission
* On invasive, non-invasive mechanical ventilation (NIV) (PEEP≥5 cmH20) or high-flow nasal canula (HFNC) oxygen therapy (minimum total flow rate of 40 lpm)
* ARDS (onset \<96h) as per the international consensus definition (P/F) ratio \< 300 on fraction of inspired oxygen (FiO2)≥0.5, with PEEP ≥5cm H2O or on HFNC), not due to cardiac causes.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this trial:
* No consent/inability to obtain consent
* Moribund patient not expected to survive 24 hours
* Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
* Currently receiving extracorporeal life support
* Pregnant or lactating
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Moderate to severe chronic liver disease (Childs-Pugh Score \> 12)
* Severe chronic respiratory disease with a baseline PaCO2 \> 50 mm Hg or the use of home oxygen
* Lung transplant patient
* Documented deep venous thrombosis or pulmonary embolism within the past 3 months
* Inability/contra-indications to receiving local standard of care thromboprophylaxis
* Chronic immunosuppression (any chronic immunotherapy including daily oral steroid use \>6months)
* Known HIV, Hep B/C positive, or active Tuberculosis
* Multisystem shock (SOFA score of \>2 in \>2 systems)
* Patient, surrogate, or physician not committed to full support including intubation (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04400032
Study Brief:
Protocol Section:
NCT04400032