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

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ClinicalTrials.gov Identifier: NCT04623671
Recruitment Status : Recruiting
First Posted : November 10, 2020
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Capricor Inc.

Brief Summary:
This is a randomized, double-blind, placebo-controlled 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.

Condition or disease Intervention/treatment Phase
Covid19 Biological: CAP-1002 Biological: Placebo Phase 2

Detailed Description:

This is a randomized, double-blind, placebo-controlled 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Syringes (60-mL) with amber film-covered barrels
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Intravenous Infusion of CAP-1002 in Patients With COVID-19 (INSPIRE)
Actual Study Start Date : November 15, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 30, 2021

Arm Intervention/treatment
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.
Biological: CAP-1002
100-mL (total volume) infusion of 150M CDCs in 5% Human Serum Albumin (HSA)
Other Names:
  • Cardiosphere-Derived Cells
  • CDCs

Placebo Comparator: Placebo
Matching placebo solution
Biological: Placebo
Matching placebo solution




Primary Outcome Measures :
  1. Safety of CAP-1002 [ Time Frame: 90 days ]
    Number of adverse events from start of treatment

  2. Efficacy of CAP-1002 on Cytokine [ Time Frame: 30 days ]
    Cytokine absolute values and changes from start of treatment to Day 30.

  3. Efficacy of CAP-1002 on Laboratory Biomarker [ Time Frame: 30 days ]
    Biomarker absolute values and changes from start of treatment to Day 30.


Other Outcome Measures:
  1. All cause mortality [ Time Frame: 30 days ]
    Number of all cause mortality cases within 30 days from start of treatment

  2. ICU Discharge [ Time Frame: 30 days ]
    Number of Intensive Care Unit (ICU) discharges within 30 days from start of treatment

  3. Duration in ICU [ Time Frame: 90 days ]
    Duration in ICU from start of treatment (up to 90 days)

  4. Hospital Discharge [ Time Frame: 30 days ]
    Number of hospital discharges within 30 days from start of treatment

  5. Hospitalization length [ Time Frame: 90 days ]
    Duration in hospital from start of treatment up to Day 90

  6. Ventilatory status [ Time Frame: 90 days ]
    Duration of time on supplemental oxygen or mechanical ventilation from start of treatment up to Day 90

  7. 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.

  8. Ordinal Scale of Clinical Improvement [ Time Frame: 30 days ]
    Absolute values and changes from start of treatment to Day 30.

  9. 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

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04623671


Contacts
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Contact: Sudhir Borgonha 3103583200 sborgonha@capricor.com
Contact: Veena Ramanna 3103583200 vramanna@capricor.com

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Tracey S Early, BS, MA, CCRP    310-423-1231    tracey.early@cshs.org   
Principal Investigator: Oren Friedman, MD         
University of California Davis Recruiting
Sacramento, California, United States, 95817
Contact: Skyler Pearson    916-734-3867    sjpearson@ucdavis.edu   
Contact: Erin Hardy    916-734-3866    eehardy@ucdavis.edu   
Principal Investigator: Tim Albertson, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Katrina Williams, RN    313-399-1539    kwilli35@hfhs.org   
Contact: Melissa Resk    3135871639    mresk1@hfhs.org   
Principal Investigator: Mayur Ramesh, MD         
United States, Texas
PharmaTex Research, LLC Recruiting
Amarillo, Texas, United States, 79109
Contact: Megan Hazelrigg    806-355-2581    mhazelrigg@ccallp.com   
Principal Investigator: David Brabham, MD         
Sponsors and Collaborators
Capricor Inc.
Investigators
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Principal Investigator: Tim Albertson, MD UC Davis
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Responsible Party: Capricor Inc.
ClinicalTrials.gov Identifier: NCT04623671    
Other Study ID Numbers: CAP-1002-COVID-19-02
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Capricor Inc.:
SARS-CoV-2
COVID
COVID-19
COVID19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases