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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT04657458
Eligibility Criteria:
Inclusion Criteria:
1. Provision of informed consent by self or proxy.
2. Stated willingness to comply with study protocol.
3. Male or female of any age ≥ 18 years of age
4. May be pregnant unless the patient has one or more conditions listed under Exclusion Criteria #3.
5. Positive Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) SARS-CoV-2.
6. Moderate to severe ARDS as defined by timing within ten days of known clinical insult or new or worsening respiratory symptoms, bilateral opacities not fully explained by effusions or lung collapse, and respiratory failure not fully explained by cardiac failure or fluid overload, minimum 5 cm H2O PEEP on mechanical ventilation, and PaO2/FiO2 ≤ 200 mmHg (if using an estimated P/F ratio, a S/F ≤ 235 is accepted).
7. Acute presentation of hypoxic respiratory failure requiring noninvasive oxygen support OR mechanical ventilation (MV).
Exclusion Criteria:
1. Active malignancy requiring treatment within the last two years, with the exception of non-melanoma skin cancers.
2. Patients who are not full code.
3. Pregnant patients with current or past history of eclampsia, preeclampsia, hemolysis, elevated liver enzymes, or low platelet count (HELLP) syndrome during pregnancy.
4. New York Heart Association (NYHA) Functional Class III (symptoms present during ordinary activities) or IV Heart Failure (symptoms present at rest) or listed for heart transplant.
5. Chronic Kidney Disease (CKD) Stage IV (GFR 15-29 mL/min/1.73m2) and Stage V (GFR \< 15 mL/min/1.73m2) or listed for kidney transplant.
6. Hepatic Impairment with Model for End-Stage Liver Disease (MELD) score ≥ 30 or listed for liver transplant.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04657458
Study Brief:
Protocol Section:
NCT04657458