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 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT05137795
Eligibility Criteria:
Inclusion criteria:
1. Severe COVID-19 , as defined by clinical signs indicative of severe systemic illness with COVID-19, being given oxygenation and meeting
ONE of the following:
Respiratory rate ≥ 30 per minute Heart rate ≥ 125 per minute SpO2 ≤ 93% on room air at sea level PaO2/FiO2 \< 300 mmHg or SpO2/FiO2 \< 315 mmHg
2. Positive test by standard RT-PCR assay or equivalent within last 7 days
3. Physician determination that patient is on SOC therapy, and will receive standard of care if patient progresses to Critical COVID-19, patient must be full CODE
Exclusion criteria:
1. Evidence of Critical COVID-19
2. Inability to utilize nebulized drugs, or history of bronchospasm with inhaled medications
3. Age \<12 years;
4. Mean arterial pressure \< 65 mm Hg after initial hospital stabilization,
5. Non-COVID-19 irreversible underlying condition with projected fatal course within 6 months or with high risk of mortality;
6. Immunosuppressive treatment for transplant or other diseases associated with high mortality;
7. Stage IV cancer or cancer on active treatment with chemotherapy immunotherapy or checkpoint inhibitors; acute renal failure or chronic renal insufficiency with GFR less than 30; CHF New York Heart Association class III or IV, new neurologic disorder in the last 3 months or chronic neurologic disorder or other that would impact on assessing the resolution of severe COVID-19 respiratory failure
8. Myocardial Infarction in previous six months or troponin \>0.5
9. Recent history of venous thrombotic events (PE / DVT) within the last 3 months.
10. New diagnosis of atrial fibrillation within the last 3 months. Acceptable if greater than 3 months and well controlled in the opinion of the investigator
11. Watery diarrhea requiring replacement of 1 liter or more of iv fluids and electrolytes
12. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT05137795
Study Brief:
Protocol Section:
NCT05137795