CAP-1002 in Severe COVID-19 Disease
CAP-1002 Treatment in Patients With Severe COVID-19 and in Critical Condition as Indicated by Life Support Measurements
1 other identifier
expanded_access
N/A
1 country
1
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.
Trial Health
Trial Health Score
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2020
CompletedFirst Posted
Study publicly available on registry
April 8, 2020
CompletedDecember 1, 2020
November 1, 2020
March 31, 2020
November 29, 2020
Conditions
Interventions
Extracellular Vesicles (EVs) from Cardiosphere-Derived Cells (CDCs)
Eligibility Criteria
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Capricor Inc.lead
Study Sites (1)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raj Makkar, MD
Cedars-Sinai Medical Center, Los Angeles, CA 90048
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2020
First Posted
April 8, 2020
Last Updated
December 1, 2020
Record last verified: 2020-11