Status:
TERMINATED
INB03 for the Treatment of Pulmonary Complications From COVID-19
Lead Sponsor:
Inmune Bio, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.
Detailed Description
The trial is a Phase 2, double-blind, randomized, placebo-controlled clinical trial of INB03 in participants with pulmonary complications due to COVID-19 infection. Patients with COVID-19 infection a...
Eligibility Criteria
Inclusion
- Have one or more of the following comorbidities:
- Age ≥ 65 years;
- Obesity (BMI ≥ 30);
- Hypertension (on one or more drugs for treatment of hypertension);
- Diabetes (on one or more drugs for Type I or Type II diabetes);
- Cardiovascular disease (on one or more drugs for treatment of cardiovascular disease, other than aspirin);
- History of congestive heart failure (CHF) or myocardial infarction (MI);
- Black or African-American race (at least one parent identifies as Black or African-American);
- Hispanic or Latino ethnicity.
- Have a positive COVID-19 test in the last 28 days;
- Have room air SaO2 \< 96%, or SpO2 \< 96% on room air at sea level, or PaO2/FiO2 \< 300;
- Have abnormal chest X-ray, MRI or CT scan consistent with pulmonary complications from COVID-19;
- Provide written informed consent prior to any study related procedures being performed.
Exclusion
- Participants will be excluded from the study if 1 or more of the following criteria are applicable at Screening:
- Age \< 18 years;
- Require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BIPAP);
- Require immediate admission to an Intensive Care Unit (ICU) for any reason;
- On therapy with approved TNF inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months;
- 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;
- Taking any medication known to be CCR5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months;
- Taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months;
- Known to be pregnant;
- Has known HIV, HCV or HBV infection;
- Has known Mycobacterium tuberculosis infection or evidence of infection on chest X-ray;
- Significant hepatic disease (ALT/AST\> 4 times the ULN);
- On therapy for cancer in the last 6 months;
- 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;
- Known hypersensitivity to investigational product or its excipients;
- Participating in an investigational drug or device trial;
- Congestive heart failure (CHF) or myocardial infarction (MI) diagnosed in the last 2 months.
Key Trial Info
Start Date :
October 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2021
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04370236
Start Date
October 21 2020
End Date
November 18 2021
Last Update
March 18 2022
Active Locations (9)
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1
NEA Baptist
Jonesboro, Arkansas, United States, 72401
2
St. Bernard's
Jonesboro, Arkansas, United States, 72401
3
Jewish Hospital
Louisville, Kentucky, United States, 40202
4
Mississippi Baptist
Kosciusko, Mississippi, United States, 39090