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Futility
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + Standard of Care | Placebo Comparator | Patients will receive placebo + standard medical care |
|
| INB03 + Standard of Care | Experimental | Patients will receive INB03 + standard medical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INB03 | Drug | Patients will receive up to two once per week subcutaneous injections of 1mg/kg INB03 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Have one or more of the following comorbidities:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Tesi, MD | Inmune Bio, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NEA Baptist | Jonesboro | Arkansas | 72401 | United States | ||
| St. Bernard's |
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| Label | URL |
|---|---|
| Company Website | View source |
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There were no stratification factors and each unblinded pharmacist was provided a randomization schedule unique to the specific site.
There were 79 patients enrolled to either INB03 + SOC (n=40) or Placebo + SOC (n=39)
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| ID | Title | Description |
|---|---|---|
| FG000 | INB03+SOC | This was the group of patients (n=40, 39 were dosed) that was randomized to and received at least one dose of INB03 |
| FG001 | Placebo+SOC | This was the group of patients (n=39, 38 were dosed) that was randomized and received at least one dose of placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | INB03 + Standard of Care | Analyzed arms/groups were INB03+SOC and Placebo+SOC |
| BG001 | Placebo + Standard of Care | Analyzed arms/groups were INB03+SOC and Placebo+SOC |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age Category (Years) | Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | mITT population | Posted | Count of Participants | Participants | 28 days |
|
Adverse event data was collected from all patients from the time of randomization until Day 70 (or discontinuation from the study)
Adverse event summary is provided below.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INB03+SOC | The clinical trial will have two treatment arms - INB03 + SOC or Placebo + SOC. All participants will receive a single dose of study drug by SC injection immediately upon randomization. Participants randomized to receive INB03 will receive INB03 1mg/kg (up to a maximum dose of 90mg) and participants randomized to Placebo will receive a SC injection of normal saline. A second dose of INB03 1mg/kg or Placebo by SC injection will be administered on Study Day 8 to participants who remain in hospital. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
An interim analysis was planned to be performed when approximately 70 participants in the mITT population had completed the Study Day 28 assessment or had an intercurrent event within 28 days on study (withdrawal or lost to follow-up). Imputation of missing data was performed.
Efficacy data, including the primary endpoint and cumulative safety data, were reviewed at the time of the interim analysis by the DMC.
A non-binding one-way futility analysis was performed as described in the SAP.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CJ Barnum, PhD | INmune Bio, Inc. | 561-710-0512 | cbarnum@inmunebio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2021 | Jan 20, 2026 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2021 | Aug 7, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000080424 | Cytokine Release Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C540591 | XENP 1595 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Placebo + Standard of Care vs. INB03 + Standard of Care
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| Placebo | Drug | Patients will receive up to two once per week subcutaneous injections of Placebo |
|
|
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 |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Jewish Hospital | Louisville | Kentucky | 40202 | United States |
| Mississippi Baptist | Kosciusko | Mississippi | 39090 | United States |
| Baptist Memorial Hospital-DeSoto | Southard | Missouri | 38671 | United States |
| Richmond University Medical Center | Staten Island | New York | 10312 | United States |
| Baptist Clinical Research Institute | Memphis | Tennessee | 38120 | United States |
| Memorial Hermann | Houston | Texas | 77030 | United States |
| Memorial Hermann Southeast | Houston | Texas | 77089 | United States |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Sex (Male, Female) | Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Measure Description: Self-reported Race Analysis was performed on all patients that were randomized and received at least one dose of INB03 (n=39, v 40 randomized) or Placebo (n=38, v 39 randomized) | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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) | The mITT population was used for this analysis | Posted | Count of Participants | Participants | Through study completion which could be up to Day 70 |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Randomization to Day 28 |
|
|
|
| Secondary | 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) | Posted | Count of Participants | Participants | Randomization to Day 28 |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Randomization to Day 28 |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Randomization to Day 28 |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Randomization to Day 28 |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Through study completion, which could be up to Day 70 |
|
|
|
| Secondary | 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 | All of the 77 randomized participants in this study were hospitalized during this study. | Posted | Mean | Standard Deviation | Day | Randomization to time of discharge or death, whichever occurs firts |
|
|
|
| Secondary | 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 | Not all patients on study reached Day 40. Not all subjects that did reach Day 40 had available samples for each inflammation marker. | Posted | Mean | Standard Deviation | ng/ML | Baseline to Day 40 |
|
|
|
| Secondary | 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 | Not all patients on study reached Day 40. Not all subjects that did reach Day 40 had available samples for each inflammation marker. | Posted | Mean | Standard Deviation | mL/min/1.73m2 | Baseline to Day 40 |
|
|
|
| Secondary | Change From Baseline in Inflammation Markers Over Time - Ferritin | Change from Baseline in COVID-19 Specific Inflammation Markers over time in mITT Population - Ferritin | Not all patients on study reached Day 40. Not all subjects that did reach Day 40 had available samples for each inflammation marker. | Posted | Mean | Standard Deviation | ug/L | Baseline to Day 40 |
|
|
|
| Secondary | 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 | Not all patients on study reached Day 40. Not all subjects that did reach Day 40 had available samples for each inflammation marker. | Posted | Mean | Standard Deviation | mg/L FEU | Baseline to Day 40 |
|
|
|
| Secondary | 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 | Not all patients on study reached Day 40. Not all subjects that did reach Day 40 had available samples for each inflammation marker. | Posted | Mean | Standard Deviation | nmol/L | Baseline to Day 40 |
|
|
|
| 4 |
| 39 |
| 8 |
| 39 |
| 4 |
| 39 |
| EG001 | Placebo+SOC | The clinical trial will have two treatment arms - INB03 + SOC or Placebo + SOC. All participants will receive a single dose of study drug by SC injection immediately upon randomization. Participants randomized to receive INB03 will receive INB03 1mg/kg (up to a maximum dose of 90mg) and participants randomized to Placebo will receive a SC injection of normal saline. A second dose of INB03 1mg/kg or Placebo by SC injection will be administered on Study Day 8 to participants who remain in hospital. | 1 | 38 | 5 | 38 | 10 | 38 |
| Cardiac Arrest | Cardiac disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Acute Respiratory Distress Syndrom | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Septic Shock | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Ischaemic Stroke | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia Bacterial | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Septic Shock | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Non-systematic Assessment |
|
| Pneumonia bacterial | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Non-systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D017670 |
| Sodium Compounds |