CAP-1002 in Severe COVID-19 Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CAP-1002 Treatment in Patients With Severe COVID-19 and in Critical Condition as Indicated by Life Support Measurements

Conditions
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COVID-19

Intervention / Treatment
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* Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects at least 18 years of age at time of consent Confirmed COVID-19 infection by clinical diagnosis and laboratory testing In critical condition as indicated by life support measurements 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells|Extracellular Vesicles (EVs) from Cardiosphere-Derived Cells (CDCs)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |