Clinical Trial Details
— Status: No longer available
Administrative data
| NCT number |
NCT04338347 |
| Other study ID # |
CAP-1002-COVID-19 |
| Secondary ID |
|
| Status |
No longer available |
| Phase |
|
| First received |
|
| Last updated |
|
Study information
| Verified date |
November 2020 |
| Source |
Capricor Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Expanded Access
|
Clinical Trial 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.
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.
