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CAP-1002 in Severe COVID-19 Disease

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04338347
Expanded Access Status : Available
First Posted : April 8, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Capricor Inc.

Brief Summary:

This randomized, double-blind, placebo-controlled trial will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing. Eligible subjects will be randomized to either CAP-1002 or placebo in a 1:1 ratio. Intravenous administration of CAP-1002 or placebo will occur at the clinical site on Day 1 and Day 7 (± 1 day) for a maximum of 2 doses, based on clinical course. Subjects will complete Screening, a Treatment Phase and a Follow-up Phase. The Treatment Phase is variable based on each subject's clinical status while the subject remains in the hospital and will contain either one or two treatment periods.

Baseline safety and efficacy assessments will be conducted prior to the first infusion. Follow-up will be conducted on Day 15 and Day 30 from the first infusion in Treatment Period 1. Subjects will be observed during the index hospitalization and monitored for outcome and safety. Transthoracic echocardiograms will be performed when indicated by clinical or laboratory evidence of cardiac involvement during the index hospitalization. Use of any concomitant medications to treat COVID-19 will be documented.

Stopping rules on the subject-level and study-level have been defined to ensure subjects are not exposed to significant risk. Oversight of the trial will be provided by independent Clinical Event Committee (CEC), Data Safety Monitoring Board (DSMB), and Medical Monitor.


Condition or disease Intervention/treatment
COVID-19 Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells

Detailed Description:

This randomized, double-blind, placebo-controlled trial will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing. Prior to protocol procedures, informed consent will be obtained from the subject or a legally authorized representative. Eligible subjects will be randomized to either CAP-1002 or placebo in a 1:1 ratio. Intravenous administration of CAP-1002 or placebo will occur at the clinical site on Day 1 and Day 7 (± 1 day) for a maximum of 2 doses, based on clinical course.

Subjects will complete Screening, a Treatment Phase and a 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 (e.g., age, gender, diabetes, COPD or respiratory conditions, body mass index, cardiovascular or renal disease) or emergent factors since the time of infection. The Treatment Phase is variable based on each subject's clinical status while the subject remains in the hospital and will contain either one or two treatment periods. Baseline safety and efficacy assessments will be conducted prior to the first infusion. Follow-up will be conducted on Day 15 and Day 30 from the first infusion in Treatment Period 1. Follow-up will either be conducted in the inpatient setting or as a phone follow-up should the subject be discharged. 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 (ECGs), clinical laboratory testing (CBC, CMP, BNP, CRP, ESR, cytokine assay, viral load, troponin I, myoglobin, ferritin, procalcitonin, ABGs, and lipid panel), chest x-rays, and adverse events. A blood sample will be collected at the clinical site and sent to a central laboratory for proteomic assay testing. Transthoracic echocardiograms will be performed when indicated by clinical or laboratory evidence of cardiac involvement during the index hospitalization. Use of any concomitant medications to treat COVID-19 will be documented.

Stopping rules on the subject-level and study-level have been defined to ensure subjects are not exposed to significant risk. Oversight of the trial will be provided by independent Clinical Event Committee (CEC), Data Safety Monitoring Board (DSMB), and Medical Monitor.

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population, Treatment IND/Protocol
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Intravenous Delivery of CAP-1002 in Patients With Severe COVID-19

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells
    Extracellular Vesicles (EVs) from Cardiosphere-Derived Cells (CDCs)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 the below criteria to maintain arterial oxygen saturation ≥ 92%, where oxygen saturation is assessed 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 artery disease based on medical record review):

    1. Patients requiring mechanical invasive intubation,
    2. Patients requiring noninvasive positive pressure ventilation,
    3. Patients on non-rebreather face masks or high-flow nasal canula (flow ≥ 6 L/min or FiO2 ≥ 40%)
  4. Elevation of at least 1 inflammatory biomarker (IL-1, IL-6, IL-10, TNF-α, ferritin, CRP) defined as ≥ 2x the upper limit of the laboratory reference value
  5. Written informed consent provided by the subject or legal representative

Exclusion Criteria:

  1. Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV)
  2. Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia
  3. Patients with untreated HIV infection
  4. Creatinine clearance less than 30 ml/minute
  5. LFTs > 5x normal
  6. Current or history (within the previous 5 years) of systemic autoimmune or connective tissue disease
  7. Known allergy or hypersensitivity to any of the investigational product constituents such as dimethyl sulfoxide (DMSO) or bovine proteins
  8. Treatment with a cell therapy product within 12 months prior to randomization
  9. Pregnant or breastfeeding at screening

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): NCT04338347


Contacts
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Contact: Siegfried Rogy, PhD 310-358-3200 clinicalresearch@capricor.com
Contact: Larry Larscheid, BS 310-358-3200 clinicalresearch@capricor.com

Locations
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United States, California
Cedars-Sinai Medical Center Available
Los Angeles, California, United States, 90048
Contact: Mitch Gheoghiu, MD    310-423-6152    Mitch.Gheorghiu@cshs.org   
Contact: Khaled Alsabaawi    310-423-6226    Khaled.Alsabaawi@cshs.org   
Sub-Investigator: Tarun Chakravarty, MD         
Sponsors and Collaborators
Capricor Inc.
Investigators
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Principal Investigator: Raj Makkar, MD Cedars-Sinai Medical Center, Los Angeles, CA 90048
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Responsible Party: Capricor Inc.
ClinicalTrials.gov Identifier: NCT04338347    
Other Study ID Numbers: CAP-1002-COVID-19
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020