INB03 for the Treatment of Pulmonary Complications From COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-21

Study Completion Date

2021-11-18

Brief Summary

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

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Placebo + Standard of Care vs. INB03 + Standard of Care

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo + Standard of Care

Patients will receive placebo + standard medical care

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will receive up to two once per week subcutaneous injections of Placebo

INB03 + Standard of Care

Patients will receive INB03 + standard medical care

Group Type EXPERIMENTAL

INB03

Intervention Type DRUG

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

Interventions

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INB03

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

Intervention Type DRUG

Placebo

Patients will receive up to two once per week subcutaneous injections of Placebo

Intervention Type DRUG

Other Intervention Names

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DN-TNF, XPro1595, XENP345, Quellor

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No