INB03 for the Treatment of Pulmonary Complications From COVID-19
- Registration Number
- NCT04370236
- Lead Sponsor
- Inmune Bio, Inc.
- 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 and low blood oxygen levels with at least one high risk factor (see below) are eligible to participate in a 40-day study to determine whether INB03 can prevent the progression of pulmonary complications.
Eligible participants will be randomized (1:1) to receive either INB03 + standard of care (SOC) or Placebo + SOC. Participants randomized to INB03 + SOC will receive a 1mg/kg injection of INB03 after randomization. Patients that remain in the hospital 7 days after the first dose will receive a second dose. A final safety visit will occur on Day 70.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 79
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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;
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Have abnormal chest X-ray, MRI or CT scan consistent with pulmonary complications from COVID-19;
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Provide written informed consent prior to any study related procedures being performed.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + Standard of Care Placebo Patients will receive placebo + standard medical care INB03 + Standard of Care INB03 Patients will receive INB03 + standard medical care
- Primary Outcome Measures
Name Time Method Proportion of participants with disease progression from randomization to 28 days post-randomization 28 days Disease progression is defined by the development of need for mechanical ventilation or death. Mechanical ventilation includes CPAP, BIPAP or mechanical ventilation requiring intubation.
- Secondary Outcome Measures
Name Time Method Length of hospital stay defined as the number of days in hospital from time of randomization to time of discharge or death, whichever occurs first; 28 days Change from baseline in inflammation markers over time. 28 days Proportion of participants with a new onset embolus or thrombus by Day 28; 28 days Proportion of participants with an increase in the WHO Ordinal Scale of Clinical Improvement score at any time during the study; 28 days Proportion of participants with all-cause mortality 28 days Proportion of participants who transfer to ICU level care by Day 28 (ICU level care is defined as a hospital setting where patient to nurse ratio is < 4); 28 days Proportion of participants with a new onset of neurologic disease (requiring medical intervention), including stroke by Day 28; 28 days Proportion of participants with evidence of new CHF or new MI requiring medical intervention by Day 28; 28 days Proportion of participants who develop a need for renal replacement therapy (defined as need for any type of dialysis including intermittent or continuous peritoneal or hemodialysis) by Day 28; 28 days
Trial Locations
- Locations (9)
NEA Baptist
🇺🇸Jonesboro, Arkansas, United States
Mississippi Baptist
🇺🇸Kosciusko, Mississippi, United States
Jewish Hospital
🇺🇸Louisville, Kentucky, 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
St. Bernard's
🇺🇸Jonesboro, Arkansas, United States