INB03 for the Treatment of Pulmonary Complications From COVID-19

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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

Key facts

Study ID: NCT04370236
Run by: Inmune Bio, Inc.
People needed: 79
Starts: 2020-10-21
Expected to finish: 2021-11-18
Last updated by the study team: 2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

NEA Baptist — Jonesboro, Arkansas, United States
St. Bernard's — Jonesboro, Arkansas, United States
Jewish Hospital — Louisville, Kentucky, United States
Mississippi Baptist — Kosciusko, Mississippi, United States
Baptist Memorial Hospital-DeSoto — Southard, Missouri, United States
Richmond University Medical Center — Staten Island, New York, United States
Baptist Clinical Research Institute — Memphis, Tennessee, United States
Memorial Hermann — Houston, Texas, United States
Memorial Hermann Southeast — Houston, Texas, United States

Full record on ClinicalTrials.gov

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