INB03 for the Treatment of Pulmonary Complications From COVID-19

NCT04370236 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: INB03-COVID-19_01
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

COVID-19

Keywords

TNF; XPro1595; DN-TNF; cytokine storm; Quellor; Anti-TNF; Anti-TNF therapy; TNF inhibitor; INB03

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Proportion of participants with all-cause mortality

  28 days

• 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

• Proportion of participants with a new onset of neurologic disease (requiring medical intervention), including stroke by Day 28;

  28 days

• Proportion of participants with evidence of new CHF or new MI requiring medical intervention by Day 28;

  28 days

• Proportion of participants with a new onset embolus or thrombus by Day 28;

  28 days

Other Outcomes (2)

• Incidence of adverse events and serious adverse events not due to underlying disease

  28 days

• Incidence of abnormal findings in clinical safety laboratory parameters, vital signs, and ECGs.

  28 days

Study Arms (2)

Placebo + Standard of Care

PLACEBO COMPARATOR

Patients will receive placebo + standard medical care

Drug: Placebo

INB03 + Standard of Care

EXPERIMENTAL

Patients will receive INB03 + standard medical care

Drug: INB03

Interventions

INB03 DRUG

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

Also known as: DN-TNF, XPro1595, XENP345, Quellor

INB03 + Standard of Care

Placebo DRUG

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

Placebo + Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have one or more of the following comorbidities:
• Age ≥ 65 years;
• Obesity (BMI ≥ 30);
• Hypertension (on one or more drugs for treatment of hypertension);
• Diabetes (on one or more drugs for Type I or Type II diabetes);
• Cardiovascular disease (on one or more drugs for treatment of cardiovascular disease, other than aspirin);
• History of congestive heart failure (CHF) or myocardial infarction (MI);
• Black or African-American race (at least one parent identifies as Black or African-American);
• Hispanic or Latino ethnicity.
• Have a positive COVID-19 test in the last 28 days;
• Have room air SaO2 \< 96%, or SpO2 \< 96% on room air at sea level, or PaO2/FiO2 \< 300;
• Have abnormal chest X-ray, MRI or CT scan consistent with pulmonary complications from COVID-19;
• Provide written informed consent prior to any study related procedures being performed.

You may not qualify if:

• Participants will be excluded from the study if 1 or more of the following criteria are applicable at Screening:
• Age \< 18 years;
• Require immediate intubation due to advanced respiratory failure - including continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BIPAP);
• Require immediate admission to an Intensive Care Unit (ICU) for any reason;
• On therapy with approved TNF inhibitor (eg: infliximab, etanercept, adalimumab, certolizumab pegol, golimumab, thalidomide, etc) in the last 6 months;
• 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;
• Taking any medication known to be CCR5 receptor antagonist (eg: leronlimab, aplaviroc, vicriviroc or maraviroc) in the last 6 months;
• Taking any medication known to inhibit the cytokine pathway (eg: anakinra, tocilizumab, siltuximab, etc) in the last 6 months;
• Known to be pregnant;
• Has known HIV, HCV or HBV infection;
• Has known Mycobacterium tuberculosis infection or evidence of infection on chest X-ray;
• Significant hepatic disease (ALT/AST\> 4 times the ULN);
• On therapy for cancer in the last 6 months;
• 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;
• Known hypersensitivity to investigational product or its excipients;

Sponsors & Collaborators

• Inmune Bio, Inc.: lead

Study Sites (9)

NEA Baptist

Jonesboro, Arkansas, 72401, United States

Location

St. Bernard's

Jonesboro, Arkansas, 72401, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Mississippi Baptist

Kosciusko, Mississippi, 39090, United States

Location

Baptist Memorial Hospital-DeSoto

Southard, Missouri, 38671, United States

Location

Richmond University Medical Center

Staten Island, New York, 10312, United States

Location

Baptist Clinical Research Institute

Memphis, Tennessee, 38120, United States

Location

Memorial Hermann

Houston, Texas, 77030, United States

Location

Memorial Hermann Southeast

Houston, Texas, 77089, United States

Location

Related Links

• Company Website

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome

Interventions

XENP 1595

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Raymond Tesi, MD

  Inmune Bio, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo + Standard of Care vs. INB03 + Standard of Care

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: April 30, 2020
• Study Start: October 21, 2020
• Primary Completion: October 13, 2021
• Study Completion: November 18, 2021
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)