INB03 for the Treatment of Pulmonary Complications From COVID-19

• Status: Recruiting
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inmune Bio, Inc.

Criteria

Inclusion Criteria:

1. Have one or more of the following comorbidities:

1. Age ≥ 65 years;

2. Obesity (BMI ≥ 30);

3. Hypertension (on one or more drugs for treatment of hypertension);

4. Diabetes (on one or more drugs for Type I or Type II diabetes);

5. Cardiovascular disease (on one or more drugs for treatment of cardiovascular disease, other than aspirin);

6. History of congestive heart failure (CHF) or myocardial infarction (MI);

7. Black or African-American race (at least one parent identifies as Black or African-American);

8. Hispanic or Latino ethnicity.

2. Have a positive COVID-19 test in the last 28 days;

3. Have room air SaO2 < 96%, or SpO2 < 96% on room air at sea level, or PaO2/FiO2 < 300;

4. Have abnormal chest X-ray, MRI or CT scan consistent with pulmonary complications from COVID-19;

5. Provide written informed consent prior to any study related procedures being performed.

Exclusion Criteria:

Participants will be excluded from the study if 1 or more of the following criteria are applicable at Screening:

1. Age < 18 years;

2. Require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BIPAP);

3. Require immediate admission to an Intensive Care Unit (ICU) for any reason;

4. On therapy with approved TNF inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months;

5. Being treated with dexamethasone (IV or PO) at a dose of >15mg per day or solumedrol or equivalent corticosteroid at a dose of >75mg per day;

6. Taking any medication known to be CCR5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months;

7. Taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months;

8. Known to be pregnant;

9. Has known HIV, HCV or HBV infection;

10. Has known Mycobacterium tuberculosis infection or evidence of infection on chest X-ray;

11. Significant hepatic disease (ALT/AST> 4 times the ULN);

12. On therapy for cancer in the last 6 months;

13. On therapy for organ transplant in the last 6 months or on a waiting list for organ transplant, including patients on renal replacement therapy for any reason;

14. Known hypersensitivity to investigational product or its excipients;

15. Participating in an investigational drug or device trial;

16. Congestive heart failure (CHF) or myocardial infarction (MI) diagnosed in the last 2 months.