ClinicalTrials.gov

History of Changes for Study: NCT04338347
CAP-1002 in Severe COVID-19 Disease
Latest version (submitted May 22, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 6, 2020 None (earliest Version on record)
2 May 2, 2020 Contacts/Locations and Study Status
3 May 22, 2020 Contacts/Locations, Study Description, Eligibility, Study Status and Study Identification
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Changes (Side-by-Side) for Study: NCT04338347
April 6, 2020 (v1) -- May 22, 2020 (v3)

Changes in: Contacts/Locations, Study Description, Study Status, Eligibility and Study Identification

Study Identification
Unique Protocol ID: CAP-1002-COVID-19 CAP-1002-COVID-19
Brief Title: CAP-1002 in Severe COVID-19 Disease CAP-1002 in Severe COVID-19 Disease
Official Title: CAP-1002 Treatment in Patients With Severe COVID-19 and in Critical Condition as Indicated by Life Support Measurements A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Intravenous Delivery of CAP-1002 in Patients With Severe COVID-19
Secondary IDs:
Study Status
Record Verification: March 2020 May 2020
Expanded Access Status: Available Available
Sponsor/Collaborators
Sponsor: Capricor Inc. Capricor Inc.
Responsible Party: Sponsor Sponsor
Collaborators:
Oversight
Study Description
Brief Summary:

This expanded access protocol will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing and who are in critical condition as indicated by life support measurements. Eligible subjects will receive open-label intravenous administration of investigational product (CAP-1002) containing 150 million allogeneic Cardiosphere-Derived Cells (CDCs). CAP-1002 administration will be conducted at the investigative site on Day 1 and weekly up to a maximum of 4 doses, based on clinical course.

Subjects will complete protocol assessments at Screening; Day 1; Weeks 1-3; and Follow-up by phone 30 and 90 days after the last infusion. Baseline assessments will be conducted prior to first infusion on Day 1.

The patient will be observed during the lengths of hospitalization and monitored for outcome and safety. Safety and outcome data will be collected and reported at the conclusion of treatment and follow-up.

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.

Detailed Description:

This is an expanded access protocol that will enroll subjects with clinical diagnosis of COVID-19 infection confirmed by laboratory testing and who are in critical condition as indicated by life support measurements. 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.

Eligible subjects will receive open-label intravenous administration of investigational product (CAP-1002) containing 150 million allogeneic Cardiosphere-Derived Cells (CDCs). CAP-1002 administration will be conducted at the investigative site on Day 1 and weekly up to a maximum of 4 doses, based on clinical course. Starting at the second CAP-1002 administration and at all subsequent administrations, medications may be administered to the subject at the Investigator's discretion based on the pre-treatment guidelines provided by Capricor and/or institutional protocols to minimize the risk of potential severe allergic reactions such as anaphylaxis. Final decisions regarding the pre-treatment medication(s), dose(s) administered, and route(s) of administration will be determined by the Investigator taking into consideration the subject's medical status, COVID-19, related conditions, concomitant medications, and medical history. For any pre-treatment medication administered, the FDA approved label will be reviewed for information on potential side effects and/or drug interactions and followed for detailed instructions on weight-based dosing.

Subjects will complete protocol assessments at Screening; Day 1; Weeks 1-3; and Follow-up by phone 30 and 90 days after the last infusion. Baseline assessments will be conducted prior to first infusion on Day 1.

The patient will be observed during the lengths of hospitalization and monitored for outcome and safety with vital signs, physical examinations, ECGs, PFTs, clinical laboratory testing (including CBC, BMP, BNP, CRP, ESR, hsCRP, cytokine assay, viral load/nasal swab), troponin I/troponin T and transthoracic echocardiogram. Additional CT and/or cardiac MRI imaging may be performed, as appropriate. Safety and outcome data (including mortality, need for additional levels of supportive care, length of stay) will be collected and reported at the conclusion of treatment and follow-up. Additional samples of blood may be collected for proteomic analysis.

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.

Conditions
Conditions: COVID-19 COVID-19
Keywords:
Study Design
Study Type: Expanded Access
Intermediate-size Population
Treatment IND/Protocol
Expanded Access
Intermediate-size Population
Treatment IND/Protocol
Interventions
Interventions: Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells
Extracellular Vesicles (EVs) from Cardiosphere-Derived Cells (CDCs)
Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells
Extracellular Vesicles (EVs) from Cardiosphere-Derived Cells (CDCs)
Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age:
Sex: All All
Gender Based:
Criteria:

Inclusion Criteria:

  1. Male or female subjects at least 18 years of age at time of consent
  2. Confirmed COVID-19 infection by clinical diagnosis and laboratory testing
  3. In critical condition as indicated by life support measurements
  4. Have one or more of the following laboratory parameters:
    • lymphocytopenia
    • elevated IL-6
    • elevated Troponin I/Troponin T (TnI/T)
    • elevated myoglobin
    • elevated C-Reactive Protein (CRP)

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
Contacts/Locations
Central Contact: Siegfried Rogy, PhD
Telephone: 818-618-5774
Email: srogy@capricor.com
Siegfried Rogy, PhD
Telephone: 310-358-3200
Email: clinicalresearch@capricor.com
Central Contact Backup: Paula Williams, MS
Telephone: 646-784-7030
Email: pwilliams@capricor.com
Larry Larscheid, BS
Telephone: 310-358-3200
Email: clinicalresearch@capricor.com
Study Officials: Raj Makkar, MD
Principal Investigator
Cedars-Sinai Medical Center, Los Angeles, CA 90048
Raj Makkar, MD
Principal Investigator
Cedars-Sinai Medical Center, Los Angeles, CA 90048
Locations: United States, CaliforniaUnited States, California
Cedars-Sinai Medical Center
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
Cedars-Sinai Medical Center
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
References
Citations:
Links:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services