Ignite Creation Date:
2024-05-06 @ 2:28 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04338347
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2020-12-01
First Post:
2020-03-31
Brief Title:
CAP-1002 in Severe COVID-19 Disease
Sponsor:
Capricor Inc
Organization:
Capricor Inc
Study Overview
Official Title:
CAP-1002 Treatment in Patients With Severe COVID-19 and in Critical Condition as Indicated by Life Support Measurements
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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 Investigators discretion based on the pre-treatment guidelines provided by Capricor andor institutional protocols to minimize the risk of potential severe allergic reactions such as anaphylaxis Final decisions regarding the pre-treatment medications doses administered and routes of administration will be determined by the Investigator taking into consideration the subjects 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 andor 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 loadnasal swab troponin Itroponin T and transthoracic echocardiogram Additional CT andor 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
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 Investigators discretion based on the pre-treatment guidelines provided by Capricor andor institutional protocols to minimize the risk of potential severe allergic reactions such as anaphylaxis Final decisions regarding the pre-treatment medications doses administered and routes of administration will be determined by the Investigator taking into consideration the subjects 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 andor 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 loadnasal swab troponin Itroponin T and transthoracic echocardiogram Additional CT andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None