INB03 for the Treatment of Pulmonary Complications From COVID-19

Purpose

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

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Placebo + Standard of Care vs. INB03 + Standard of Care
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo + Standard of Care 		Patients will receive placebo + standard medical care
  • Drug: Placebo
    Patients will receive up to two once per week subcutaneous injections of Placebo
    Other names:
    • Saline
Experimental
INB03 + Standard of Care 		Patients will receive INB03 + standard medical care
  • Drug: INB03
    Patients will receive up to two once per week subcutaneous injections of 1mg/kg INB03
    Other names:
    • DN-TNF, XPro1595, XENP345, Quellor

Recruiting Locations

More Details

NCT ID
NCT04370236
Status
Terminated
Sponsor
Inmune Bio, Inc.

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.