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 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 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 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
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
NEA Baptist🇺🇸Jonesboro, Arkansas, United States