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INB03 for the Treatment of Pulmonary Complications From COVID-19
INB03 for the Treatment of Pulmonary Complications From COVID-19
TerminatedPhase 2, Phase 3
Sponsor: Inmune Bio, Inc.
Conditions: COVID-19
Interventions: INB03, Placebo
Countries: United States
The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility 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.
Locations (9)
- Jonesboro, Arkansas, United States
- Jonesboro, Arkansas, United States
- Louisville, Kentucky, United States
- Kosciusko, Mississippi, United States
- Southard, Missouri, United States
- Staten Island, New York, United States
- Memphis, Tennessee, United States
- Houston, Texas, United States
- Houston, Texas, United States