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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT04579393
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Patient must be hospitalized, or had their inpatient stay extended, for COVID-19.
2. Age \>=18 years
3. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
4. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
5. Females of childbearing potential must agree to be abstinent or use a medical acceptable form of contraception from the time of enrollment through 30 days after last day of study drug
6. Laboratory confirmed SARS-CoV-2 RT-PCR test within 7 days of enrollment
7. Illness of any duration with SpO2 of less than 94% on room air requiring supplemental oxygen via nasal canula or non-invasive mechanical ventilation, or mechanical ventilation or ECMO (5 to 7 on the 8-point scale)
EXCLUSION CRITERIA:
1. ALT or AST \> 5 times the upper limit of normal (ULN) or ALT or AST \>= 3 x ULN and total bilirubin \> 2 x ULN.
2. Estimated glomerular filtration rate (eGFR) \<30ml/min
3. Pregnancy or breast feeding
4. Anticipated discharge in the next 72 hours
5. Allergy to study medication
6. Uncontrolled hypertension (systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg)
7. Shock or hypotension at the time of enrollment
8. Neutrophil count \<1000/microliter
9. Concern for bacterial or fungal sepsis
10. Received immunomodulatory treatment within 30 days prior to enrollment e.g., Bruton's tyrosine kinase/phosphoinositide 3 kinase/Janus kinase inhibitor or cytokine-targeting biologic therapy (anti-TNF, IL-6)
11. Received a live vaccine the last 4 weeks
12. Those who were cognitively impaired or mentally disabled prior to COVID diagnosis
13. Participation in another clinical trial for the treatment of COVID-19.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04579393
Study Brief:
Protocol Section:
NCT04579393