Back to resultsINB03 for the Treatment of Pulmonary Complications From COVID-19
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
INB03
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring TNF, XPro1595, DN-TNF, cytokine storm, Quellor, Anti-TNF, Anti-TNF therapy, TNF inhibitor, INB03
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
- Participating in an investigational drug or device trial;
- Congestive heart failure (CHF) or myocardial infarction (MI) diagnosed in the last 2 months.
Sites / Locations
- NEA Baptist
- St. Bernard's
- Jewish Hospital
- Mississippi Baptist
- Baptist Memorial Hospital-DeSoto
- Richmond University Medical Center
- Baptist Clinical Research Institute
- Memorial Hermann
- Memorial Hermann Southeast
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo + Standard of Care
INB03 + Standard of Care
Arm Description
Patients will receive placebo + standard medical care
Patients will receive INB03 + standard medical care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of participants with all-cause mortality
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);
Proportion of participants with a new onset of neurologic disease (requiring medical intervention), including stroke by Day 28;
Proportion of participants with evidence of new CHF or new MI requiring medical intervention by Day 28;
Proportion of participants with a new onset embolus or thrombus by Day 28;
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;
Proportion of participants with an increase in the WHO Ordinal Scale of Clinical Improvement score at any time during the study;
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;
Change from baseline in inflammation markers over time.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04370236
Brief Title
INB03 for the Treatment of Pulmonary Complications From COVID-19
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Futility
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
October 13, 2021 (Actual)
Study Completion Date
November 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inmune Bio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
TNF, XPro1595, DN-TNF, cytokine storm, Quellor, Anti-TNF, Anti-TNF therapy, TNF inhibitor, INB03
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Placebo + Standard of Care vs. INB03 + Standard of Care
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo + Standard of Care
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo + standard medical care
Arm Title
INB03 + Standard of Care
Arm Type
Experimental
Arm Description
Patients will receive INB03 + standard medical care
Intervention Type
Drug
Intervention Name(s)
INB03
Other Intervention Name(s)
DN-TNF, XPro1595, XENP345, Quellor
Intervention Description
Patients will receive up to two once per week subcutaneous injections of 1mg/kg INB03
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive up to two once per week subcutaneous injections of Placebo
Primary Outcome Measure Information:
Title
Proportion of participants with disease progression from randomization to 28 days post-randomization
Description
Disease progression is defined by the development of need for mechanical ventilation or death. Mechanical ventilation includes CPAP, BIPAP or mechanical ventilation requiring intubation.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Proportion of participants with all-cause mortality
Time Frame
28 days
Title
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);
Time Frame
28 days
Title
Proportion of participants with a new onset of neurologic disease (requiring medical intervention), including stroke by Day 28;
Time Frame
28 days
Title
Proportion of participants with evidence of new CHF or new MI requiring medical intervention by Day 28;
Time Frame
28 days
Title
Proportion of participants with a new onset embolus or thrombus by Day 28;
Time Frame
28 days
Title
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;
Time Frame
28 days
Title
Proportion of participants with an increase in the WHO Ordinal Scale of Clinical Improvement score at any time during the study;
Time Frame
28 days
Title
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;
Time Frame
28 days
Title
Change from baseline in inflammation markers over time.
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
Incidence of adverse events and serious adverse events not due to underlying disease
Time Frame
28 days
Title
Incidence of abnormal findings in clinical safety laboratory parameters, vital signs, and ECGs.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
Participating in an investigational drug or device trial;
Congestive heart failure (CHF) or myocardial infarction (MI) diagnosed in the last 2 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Tesi, MD
Organizational Affiliation
Inmune Bio, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
NEA Baptist
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
St. Bernard's
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Mississippi Baptist
City
Kosciusko
State/Province
Mississippi
ZIP/Postal Code
39090
Country
United States
Facility Name
Baptist Memorial Hospital-DeSoto
City
Southard
State/Province
Missouri
ZIP/Postal Code
38671
Country
United States
Facility Name
Richmond University Medical Center
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Baptist Clinical Research Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Memorial Hermann Southeast
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.inmunebio.com
Description
Company Website
Learn more about this trial
INB03 for the Treatment of Pulmonary Complications From COVID-19
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