INB03 for the Treatment of Pulmonary Complications From COVID-19

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

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

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: Placebo; Drug: INB03

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist
    • Jonesboro, Arkansas, United States, 72401
      • St. Bernard's
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital
  • Mississippi
    • Kosciusko, Mississippi, United States, 39090
      • Mississippi Baptist
  • Missouri
    • Southard, Missouri, United States, 38671
      • Baptist Memorial Hospital-DeSoto
  • New York
    • Staten Island, New York, United States, 10312
      • Richmond University Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Clinical Research Institute
  • Texas
    • Houston, Texas, United States, 77030
      • Memorial Hermann
    • Houston, Texas, United States, 77089
      • Memorial Hermann Southeast

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo + Standard of Care; Patients will receive placebo + standard medical care	Drug: Placebo; Patients will receive up to two once per week subcutaneous injections of Placebo; Other Names: Saline
Experimental: INB03 + Standard of Care; Patients will receive INB03 + standard medical care	Drug: INB03; Patients will receive up to two once per week subcutaneous injections of 1mg/kg INB03; Other Names: DN-TNF, XPro1595, XENP345, Quellor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cochran-Mantel-Haenszel Analysis of Proportion of Patients With Disease Progression	Primary Endpoint: Cochran-Mantel-Haenszel Analysis of Proportion of Patients with Disease Progression (mITT Population)	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients With All-cause Mortality	Assessing the effect of INB03 on all-cause mortality in participants with pulmonary complications from COVID-19 infection (mITT Population)	Through study completion which could be up to Day 70
Proportion Transferred to ICU Level Care by Day 28	Proportion of participants who transferred to ICU level care by Day 28 (ICU level care is defined as a hospital setting where patient to nurse ratio is < 4) - mITT population	Randomization to Day 28
Proportion With New Onset of Neurologic Disease by Day 28	Proportion of participants with a new onset of neurologic disease (requiring medical intervention), including stroke by Day 28 (mITT population)	Randomization to Day 28
Proportion With Evidence of New CHF or New MI Requiring Medical Intervention by Day 28	Proportion of participants with evidence of new CHF or new MI requiring medical intervention by Day 28 - mITT population	Randomization to Day 28
Proportion With New Onset Embolus or Thrombus by Day 28	Proportion of participants with a new onset embolus or thrombus by Day 28 - mITT population	Randomization to Day 28
Proportion Developing a Need for Renal Replacement Therapy 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 - mITT population	Randomization to Day 28
Proportion With an Increase in the WHO Ordinal Scale of Clinical Improvement Score at Any Time During the Study	Proportion of participants with an increase in the WHO Ordinal Scale of Clinical Improvement score at any time during the study - mITT population	Through study completion, which could be up to Day 70
Length of Hospital Stay	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, mITT population	Randomization to time of discharge or death, whichever occurs firts
Change From Baseline in Inflammation Markers Over Time - Troponin I	Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - Troponin I	Baseline to Day 40
Change From Baseline in Inflammation Markers Over Time - Glomerular Filtration Rate	Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - Glomerular Filtration Rate	Baseline to Day 40
Change From Baseline in Inflammation Markers Over Time - Ferritin	Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - Ferritin	Baseline to Day 40
Change From Baseline in Inflammation Markers Over Time - D-Dimer	Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - D-Dimer	Baseline to Day 40
Change From Baseline in Inflammation Markers Over Time - CRP	Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - C-Reactive Protein	Baseline to Day 40

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Inmune Bio, Inc.
• Investigators: Study Chair: Raymond Tesi, MD, Inmune Bio, Inc.

Publications and helpful links

Helpful Links

• Company Website

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Actual): October 13, 2021
• Study Completion (Actual): November 18, 2021

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Anti-TNF; TNF; cytokine storm; TNF inhibitor; Anti-TNF therapy; XPro1595; DN-TNF; Quellor; INB03
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Shock; Pathological Conditions, Signs and Symptoms; COVID-19; Cytokine Release Syndrome; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride; XENP 1595
• Other Study ID Numbers: INB03-COVID-19_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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