Exploratory Regimen of Basiliximab for Treatment of Pulmonary Cytokine Storm in SARS-CoV-2 Hospitalized Adult Patients

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To explore the efficacy of treatment of pulmonary cytokine storm induced by SARS-CoV2 with a monoclonal antibody to IL-2 (Basiliximab) in addition to current standard of care vs current standard of care with the primary efficacy endpoint being the proportion of subjects alive and free of ventilator support, defined as intubation and requiring mechanical ventilation, at Day 28 from time of randomization.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fort Worth Clinical Sciences Working Group
• Collaborator: TCU and UNTHSC School of Medicine
• Treatments: Basiliximab

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