INB03 for the Treatment of Pulmonary Complications From COVID-19

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04370236
• Other study ID #: INB03-COVID-19_01
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: October 21, 2020
• Est. completion date: November 18, 2021

Study information

• Verified date: March 2022
• Source: Inmune Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 79
• Est. completion date: November 18, 2021
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• INB03
Patients will receive up to two once per week subcutaneous injections of 1mg/kg INB03
• Placebo
Patients will receive up to two once per week subcutaneous injections of Placebo

Locations

Country	Name	City	State
United States	Memorial Hermann	Houston	Texas
United States	Memorial Hermann Southeast	Houston	Texas
United States	NEA Baptist	Jonesboro	Arkansas
United States	St. Bernard's	Jonesboro	Arkansas
United States	Mississippi Baptist	Kosciusko	Mississippi
United States	Jewish Hospital	Louisville	Kentucky
United States	Baptist Clinical Research Institute	Memphis	Tennessee
United States	Baptist Memorial Hospital-DeSoto	Southard	Missouri
United States	Richmond University Medical Center	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Inmune Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events and serious adverse events not due to underlying disease		28 days
Other	Incidence of abnormal findings in clinical safety laboratory parameters, vital signs, and ECGs.		28 days
Primary	Proportion of participants with disease progression from randomization to 28 days post-randomization	Disease progression is defined by the development of need for mechanical ventilation or death. Mechanical ventilation includes CPAP, BIPAP or mechanical ventilation requiring intubation.	28 days
Secondary	Proportion of participants with all-cause mortality		28 days
Secondary	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
Secondary	Proportion of participants with a new onset of neurologic disease (requiring medical intervention), including stroke by Day 28;		28 days
Secondary	Proportion of participants with evidence of new CHF or new MI requiring medical intervention by Day 28;		28 days
Secondary	Proportion of participants with a new onset embolus or thrombus by Day 28;		28 days
Secondary	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
Secondary	Proportion of participants with an increase in the WHO Ordinal Scale of Clinical Improvement score at any time during the study;		28 days
Secondary	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
Secondary	Change from baseline in inflammation markers over time.		28 days

External Links

•   Company Website