CAP-1002 in Severe COVID-19 Disease

NO_LONGER_AVAILABLE

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04338347

Run by

Capricor Inc.

Last updated by the study team

2020-12-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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