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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT05013034
Eligibility Criteria:
Inclusion Criteria:
Subject Inclusion Criteria
1. Patient or legally authorized representative (LAR) willing and able to provide written or electronic or otherwise FDA-acceptable informed consent based on current FDA regulations.
2. Hospitalized male or non-pregnant female
3. RT-PCR confirmed SARS-CoV-2 using WHO consensus or validated primers
4. Meet the Following Criteria:
1. Deficiency in Oxygenation as defined by the Berlin ARDS Criteria (27):
Timing: Within 1 week of onset of symptoms Imaging: Bilateral pulmonary infiltrates
Oxygenation (any):
Mild: 200 mmHg \< PaO2/FiO2 ≤ 300 mmHg Moderate: 100 mmHg \< PaO2/FiO2 ≤ 200 mmHg Severe: PaO2/FiO2 ≤ 100 mmHg and
2. Requiring oxygen support in the form of High Flow Nasal Cannula (HFNC), non-invasive positive pressure ventilation, intubation and mechanical ventilation, or initiation of ECMO and
3. Any one or more of the following:
1. Elevated CRP (\>10 gm/dL)
2. Elevated Ferritin (\>1000)
3. Neutrophil/lymphocyte ratio \>3.3
5. Patient will receive current clinical standard of care. This includes inpatient use of remdesivir, dexamethasone, convalescent plasma, or pre-hospitalization outpatient treatment with casirivimab and imdevima
6. Age ≥ 18 years
Exclusion Criteria:
1. Off label use of other drugs
2. WOCBP unwilling to use acceptable birth control for 5 weeks, or male partner of a WOCBP unwilling to use male barrier method (condom) plus effective second method birth control for partner
3. Pregnant women
4. Pancytopenia
1. Hgb\< 8 g/dL (male) or \< 7 g/dL (female)
2. WBC\<2.0 x 109/L
3. PLT\< 50 x 109/L
4\) Enrollment in any study using immunomodulatory therapies (monoclonal antibodies, small molecule inhibitors etc. to interleukins or interleukin-receptor) 5) Any subjects who have received treatment with immunomodulators or immunosuppressant drugs, including but not limited to IL-6 inhibitors, TNF inhibitors, anti-IL-1 agents, and JAK inhibitors within 5 half-lives or 30 days (whichever is longer) prior to randomization.
6\) Known/established systemic bacteremia (empiric antibiotics are allowed), uncontrolled viral infection besides the SARS-CoV-2 study disease, significant abscess in the opinion of the investigator, or any other finding that, in the opinion of the investigator, poses undue risk for treatment with basiliximab.
7\) Any patient with multi-organ system failure or on intravenous vasopressor support 8) Do-not-resuscitate status at time of consent, or any contraindication to invasive mechanical ventilation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05013034
Study Brief:
Protocol Section:
NCT05013034