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 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT04398303
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients age 18 to 85, inclusive
2. Confirmed positive test for COVID-19 by standard reverse transcriptase polymerase chain reaction (RT-PCR) assay or equivalent
3. On mechanical ventilation (n=35), or high-flow O2 support (n=35) and:
1. Disease severity level of "moderate" (PaO2/FiO2 of 100-200) (n=35), or "severe" (PaO2/FiO2 \< 100) (n=35) as established using the Berlin Criteria for ARDS (Barbas, Isola \& Caser, 2014; Baron \& Levy, 2016).
2. Positive end-expiratory airway pressure (PEEP) ≥ 5 cmH2O
3. Oxygen saturation ≤ 93%
4. Non-cardiogenic bilateral pulmonary edema on frontal chest radiograph that cannot be explained by effusion, collapsed lung or lung nodule
5. Able to understand and provide voluntary informed consent
Exclusion Criteria:
1. Unable to understand and provide voluntary informed consent
2. Current infection with HIV-1, HIV-2, Hepatitis B, Hepatitis C or HTLV
3. History of malignancy, other than non-melanoma skin cancer or non-metastatic prostate cancer
4. Currently receiving extracorporeal life support or high-frequency oscillatory ventilation
5. Weight \> 150 kg
6. Current severe chronic respiratory disease, as demonstrated by:
1. PaCO2 \> 50 mm Hg, or
2. history of use of home oxygen
7. Major trauma within the past 7 days
8. Lung transplant recipient
9. WHO Class III or IV pulmonary hypertension
10. Documented deep vein thrombosis or pulmonary embolism within the past 3 months
11. Currently pregnant or lactating
12. Currently participating in another clinical trial, or participation in another clinical trial within 30 days of enrollment
13. Hypersensitivity to Dextran-40 or Dimethyl Sulfoxide (DMSO)
14. Current pharmacotherapy using hydroxychloroquine or Interleukin-6 inhibitors
15. History of CVA or MI within 180 days of study enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04398303
Study Brief:
Protocol Section:
NCT04398303