The purpose of this study is to determine whether XPro1595 can prevent the progression of respiratory complications in COVID19 patients.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
79
NEA Baptist
Jonesboro, Arkansas, United States
St. Bernard's
Jonesboro, Arkansas, United States
Jewish Hospital
Louisville, Kentucky, United States
Mississippi Baptist
Kosciusko, Mississippi, United States
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)
Time frame: 28 days
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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Randomization to Day 28
Proportion Developing a Need for Renal Replacement Therapy by Day 28
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Baptist Memorial Hospital-DeSoto
Southard, Missouri, United States
Richmond University Medical Center
Staten Island, New York, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
Memorial Hermann
Houston, Texas, United States
Memorial Hermann Southeast
Houston, Texas, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Day 40