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Intravenous Infusion of CAP-1002 in Patients With COVID-19 (INSPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04623671
Recruitment Status : Active, not recruiting
First Posted : November 10, 2020
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Capricor Inc.

Tracking Information
First Submitted Date  ICMJE October 7, 2020
First Posted Date  ICMJE November 10, 2020
Last Update Posted Date January 19, 2022
Actual Study Start Date  ICMJE November 15, 2020
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2022)
  • Number of all-cause mortality cases [ Time Frame: 30 days ]
    All cause mortality within 30 days from start of treatment
  • Efficacy of CAP-1002 on Cytokine [ Time Frame: 30 days ]
    Cytokine absolute values and changes from start of treatment to Day 30.
  • Efficacy of CAP-1002 on Laboratory Biomarker [ Time Frame: 30 days ]
    Biomarker absolute values and changes from start of treatment to Day 30.
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2020)
  • Safety of CAP-1002 [ Time Frame: 90 days ]
    Number of adverse events from start of treatment
  • Efficacy of CAP-1002 on Cytokine [ Time Frame: 30 days ]
    Cytokine absolute values and changes from start of treatment to Day 30.
  • Efficacy of CAP-1002 on Biomarker [ Time Frame: 30 days ]
    Biomarker absolute values and changes from start of treatment to Day 30.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 4, 2022)
  • Number of Intensive Care Unit (ICU) discharges [ Time Frame: 30 days ]
    First Intensive Care Unit (ICU) discharge within 30 days from start of treatment
  • Number of Days in ICU [ Time Frame: 90 days ]
    Duration in ICU from start of treatment (up to 90 days)
  • Number of hospital discharges [ Time Frame: 30 days ]
    Discharge from hospital within 30 days from start of treatment
  • Number of Days in hospital [ Time Frame: 90 days ]
    Hospitalization length from start of treatment up to Day 90
  • WHO Ordinal Improvement [ Time Frame: 90 days ]
    Time to a 1-point decrease (indicative of improvement) on the WHO Ordinal Scale of Clinical Improvement from start of treatment
  • Severity vs. Time [ Time Frame: 30 days ]
    Area under the severity versus time curve, where severity is defined by the Ordinal Scale of Clinical Improvement and time is measured from start of treatment to Day 30
  • Ordinal Scale of Clinical improvement [ Time Frame: 30 days ]
    absolute values and changes from start of treatment up to Day 30. Minimum score is 0 which is uninfected and the maximum score is 8 which indicates death. Ascending scores signify worse outcome
Original Other Pre-specified Outcome Measures
 (submitted: November 9, 2020)
  • All cause mortality [ Time Frame: 30 days ]
    Number of all cause mortality cases within 30 days from start of treatment
  • ICU Discharge [ Time Frame: 30 days ]
    Number of Intensive Care Unit (ICU) discharges within 30 days from start of treatment
  • Duration in ICU [ Time Frame: 90 days ]
    Duration in ICU from start of treatment (up to 90 days)
  • Hospital Discharge [ Time Frame: 30 days ]
    Number of hospital discharges within 30 days from start of treatment
  • Hospitalization length [ Time Frame: 90 days ]
    Duration in hospital from start of treatment up to Day 90
  • Ventilatory status [ Time Frame: 90 days ]
    Duration of time on supplemental oxygen or mechanical ventilation from start of treatment up to Day 90
  • Acute Respiratory Distress [ Time Frame: 30 days ]
    Severity of ARDS as defined by the Berlin criteria, absolute values and changes from start of treatment to Day 30.
  • Ordinal Scale of Clinical Improvement [ Time Frame: 30 days ]
    Absolute values and changes from start of treatment to Day 30.
  • WHO Ordinal Improvement [ Time Frame: 90 days ]
    Time to a 1-point decrease (indicative of improvement) on the WHO Ordinal Scale of Clinical Improvement from start of treatment
  • Severity vs. Time [ Time Frame: 30 days ]
    Area under the severity versus time curve, where severity is defined by the Ordinal Scale of Clinical Improvement and time is measured from start of treatment to Day 30
 
Descriptive Information
Brief Title  ICMJE Intravenous Infusion of CAP-1002 in Patients With COVID-19
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Intravenous Infusion of CAP-1002 in Patients With COVID-19 (INSPIRE)
Brief Summary This is a randomized, double-blind, placebo-controlled, Pilot, Phase 2 Exploratory study that will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing and who are in severe or critical condition as indicated by life-support measures.
Detailed Description

This is a randomized, double-blind, placebo-controlled Pilot, Phase 2 Exploratory study that will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing and who are in severe or critical condition as indicated by life-support measures. Prior to protocol procedures, informed consent will be obtained from the subject or a legally authorized representative. Subjects will undergo a screening evaluation to determine eligibility based on the protocol inclusion and exclusion criteria.

The primary objectives of the study are to determine the safety and effectiveness of intravenously infused CAP-1002 in improving clinical outcomes in severely or critically ill patients with COVID-19.

Eligible subjects will be randomized to either the CAP-1002 or placebo group (1:1 ratio) and undergo baseline safety and efficacy assessments approximately 1 to 5 days prior to the administration of investigational product (IP). Treatment administration consists of IP consisting of 150M CDCs or matching placebo on study Day 1. Background standard of care treatment and practices will be maintained for all patients enrolled in the study.

Subjects will complete Screening followed by a Treatment and Follow-up phase. A detailed medical history will be collected, including the presence of any co-morbidities and risk factors believed to be associated with COVID-19 outcomes or emergent factors since the time of infection. Eligibility must be reviewed and confirmed on Day 1 prior to the infusion of IP.

Subjects will be observed during the index hospitalization and monitored for outcome and safety with vital signs (heart rate, blood pressure, respiratory rate, and oxygen saturation), physical examinations, electrocardiograms, clinical laboratory testing including complete blood count and comprehensive metabolic panel, inflammatory markers and adverse events. Blood samples will be collected and submitted to a central laboratory for future proteomic assay assessment. Use of any concomitant medications to treat COVID-19 will be documented.

Follow-up will be conducted on Days 2, 3, 7, 15, 30, 60, and 90 either in the inpatient setting or by telephone if the subject has been discharged. All subject participation will be a maximum of 13 weeks from Screening.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Syringes (60-mL) with amber film-covered barrels
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Biological: CAP-1002
    100-mL (total volume) infusion of 150M CDCs in 5% Human Serum Albumin (HSA)
    Other Names:
    • Cardiosphere-Derived Cells
    • CDCs
  • Biological: Placebo
    Matching placebo solution
Study Arms  ICMJE
  • Active Comparator: CAP-1002
    The active pharmaceutical ingredient in CAP-1002 is Cardiosphere-Derived Cells (CDCs). CDCs are known to secrete numerous bioactive elements (growth factors, exosomes) which impact the therapeutic benefits of the cell-based therapy. The mechanism of action is the composite ability to be immunomodulatory, anti-fibrotic and regenerative.
    Intervention: Biological: CAP-1002
  • Placebo Comparator: Placebo
    Matching placebo solution
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 4, 2022)
63
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2020)
60
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female subjects at least 18 years of age at time of consent.
  2. Diagnosis of SARS-CoV-2 infection confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay.
  3. Compromised respiratory status as defined by arterial oxygen saturation < 92% (oxygen saturation measured by pulse oximetry) OR cardiomyopathy due to COVID-19 (defined as a new drop in ejection fraction to ≤ 50% during COVID-19 with no evidence of obstructive coronary artery disease based on medical records review).
  4. Elevation of at least 1 inflammatory marker (IL-1, IL-6, IL-10, TNF-α, ferritin, CRP) defined as ≥ 2x upper limit of laboratory normal reference value.
  5. Written informed consent provided by subject or legal representative.

Exclusion Criteria:

  1. Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV).
  2. Patients who have been intubated.
  3. Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia.
  4. Patients with untreated human immunodeficiency virus (HIV) infection.
  5. Creatinine clearance less than 30 mL/minute.
  6. Liver function tests > 5x normal.
  7. Current or history (within the previous 5 years) of systemic autoimmune or connective tissue disease.
  8. Known allergy or hypersensitivity to any of the IP constituents such as dimethyl sulfoxide (DMSO) or bovine proteins.
  9. Treatment with a cell therapy product within 12 months prior to randomization.
  10. Participation in an ongoing protocol studying an experimental drug or device.
  11. Pregnant or breastfeeding female subjects, and sexually active female subjects of childbearing potential not willing to use contraceptive methods.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04623671
Other Study ID Numbers  ICMJE CAP-1002-COVID-19-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Capricor Inc.
Study Sponsor  ICMJE Capricor Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tim Albertson, MD UC Davis
PRS Account Capricor Inc.
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP