INB03 for the Treatment of Pulmonary Complications From COVID-19

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of INB03 in the Treatment of Participants With Pulmonary Complications From Coronavirus Disease (COVID-19)

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

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.

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.