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INB03 for the Treatment of Pulmonary Complications From COVID-19
INB03 for the Treatment of Pulmonary Complications From COVID-19

NCT04370236

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