Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04623671
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2020-10-07
Brief Title:
Intravenous Infusion of CAP-1002 in Patients With COVID-19
Sponsor:
Capricor Inc
Organization:
Capricor Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study Evaluating the Safety and Efficacy of Intravenous Infusion of CAP-1002 in Patients With COVID-19 INSPIRE
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRE
Brief Summary:
This is a randomized double-blind placebo-controlled Pilot Phase 2 Exploratory study that will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing and who are in severe or critical condition as indicated by life-support measures
Detailed Description:
This is a randomized double-blind placebo-controlled Pilot Phase 2 Exploratory study that will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing and who are in severe or critical condition as indicated by life-support measures 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
The primary objectives of the study are to determine the safety and effectiveness of intravenously infused CAP-1002 in improving clinical outcomes in severely or critically ill patients with COVID-19
Eligible subjects will be randomized to either the CAP-1002 or placebo group 11 ratio and undergo baseline safety and efficacy assessments approximately 1 to 5 days prior to the administration of investigational product IP Treatment administration consists of IP consisting of 150M CDCs or matching placebo on study Day 1 Background standard of care treatment and practices will be maintained for all patients enrolled in the study
Subjects will complete Screening followed by a Treatment and Follow-up phase A detailed medical history will be collected including the presence of any co-morbidities and risk factors believed to be associated with COVID-19 outcomes or emergent factors since the time of infection Eligibility must be reviewed and confirmed on Day 1 prior to the infusion of IP
Subjects will be observed during the index hospitalization and monitored for outcome and safety with vital signs heart rate blood pressure respiratory rate and oxygen saturation physical examinations electrocardiograms clinical laboratory testing including complete blood count and comprehensive metabolic panel inflammatory markers and adverse events Blood samples will be collected and submitted to a central laboratory for future proteomic assay assessment Use of any concomitant medications to treat COVID-19 will be documented
Follow-up will be conducted on Days 2 3 7 15 30 60 and 90 either in the inpatient setting or by telephone if the subject has been discharged All subject participation will be a maximum of 13 weeks from Screening
The primary objectives of the study are to determine the safety and effectiveness of intravenously infused CAP-1002 in improving clinical outcomes in severely or critically ill patients with COVID-19
Eligible subjects will be randomized to either the CAP-1002 or placebo group 11 ratio and undergo baseline safety and efficacy assessments approximately 1 to 5 days prior to the administration of investigational product IP Treatment administration consists of IP consisting of 150M CDCs or matching placebo on study Day 1 Background standard of care treatment and practices will be maintained for all patients enrolled in the study
Subjects will complete Screening followed by a Treatment and Follow-up phase A detailed medical history will be collected including the presence of any co-morbidities and risk factors believed to be associated with COVID-19 outcomes or emergent factors since the time of infection Eligibility must be reviewed and confirmed on Day 1 prior to the infusion of IP
Subjects will be observed during the index hospitalization and monitored for outcome and safety with vital signs heart rate blood pressure respiratory rate and oxygen saturation physical examinations electrocardiograms clinical laboratory testing including complete blood count and comprehensive metabolic panel inflammatory markers and adverse events Blood samples will be collected and submitted to a central laboratory for future proteomic assay assessment Use of any concomitant medications to treat COVID-19 will be documented
Follow-up will be conducted on Days 2 3 7 15 30 60 and 90 either in the inpatient setting or by telephone if the subject has been discharged All subject participation will be a maximum of 13 weeks from Screening
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None