Clinical trial NCT04370236: 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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: TNF
XPro1595
DN-TNF
cytokine storm
Quellor
Anti-TNF
Anti-TNF therapy
TNF inhibitor
INB03
Lead sponsor: Inmune Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-30
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo + Standard of Care vs. INB03 + Standard of Care
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of participants with disease progression from randomization to 28 days post-randomization
timeFrame: 28 days
Secondary outcomes:
measure: Proportion of participants with all-cause mortality
timeFrame: 28 days
measure: 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);
timeFrame: 28 days
measure: Proportion of participants with a new onset of neurologic disease (requiring medical intervention), including stroke by Day 28;
timeFrame: 28 days
measure: Proportion of participants with evidence of new CHF or new MI requiring medical intervention by Day 28;
timeFrame: 28 days
measure: Proportion of participants with a new onset embolus or thrombus by Day 28;
timeFrame: 28 days
measure: 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;
timeFrame: 28 days
measure: Proportion of participants with an increase in the WHO Ordinal Scale of Clinical Improvement score at any time during the study;
timeFrame: 28 days
measure: 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;
timeFrame: 28 days
measure: Change from baseline in inflammation markers over time.
timeFrame: 28 days
Other outcomes:
measure: Incidence of adverse events and serious adverse events not due to underlying disease
timeFrame: 28 days
measure: Incidence of abnormal findings in clinical safety laboratory parameters, vital signs, and ECGs.
timeFrame: 28 days
Locations:
city: Jonesboro
country: United States
facility: NEA Baptist
state: Arkansas
city: Jonesboro
country: United States
facility: St. Bernard's
state: Arkansas
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Kosciusko
country: United States
facility: Mississippi Baptist
state: Mississippi
city: Southard
country: United States
facility: Baptist Memorial Hospital-DeSoto
state: Missouri
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Memphis
country: United States
facility: Baptist Clinical Research Institute
state: Tennessee
city: Houston
country: United States
facility: Memorial Hermann
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Southeast
state: Texas
Study officials:
affiliation: Inmune Bio, Inc.
name: Raymond Tesi, MD
role: STUDY_CHAIR
References: