INB03 for the Treatment of Pulmonary Complications From COVID-19

INmune Bio

Status and phase: Terminated; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: INB03

Study type: Interventional

Funder types: Industry

Identifiers

NCT04370236

INB03-COVID-19_01

Details and patient eligibility

About

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

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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79 participants in 2 patient groups, including a placebo group

Placebo + Standard of Care

Placebo Comparator group

Description:

Patients will receive placebo + standard medical care

Treatment:

Drug: Placebo

INB03 + Standard of Care

Experimental group

Description:

Patients will receive INB03 + standard medical care

Treatment:

Drug: INB03