Intravenous Infusion of CAP-1002 in Patients With COVID-19
INSPIRE
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Intravenous Infusion of CAP-1002 in Patients With COVID-19 (INSPIRE)
1 other identifier
interventional
55
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 covid19
Started Nov 2020
Typical duration for phase_2 covid19
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
November 10, 2020
CompletedStudy Start
First participant enrolled
November 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2022
CompletedResults Posted
Study results publicly available
February 20, 2025
CompletedFebruary 20, 2025
January 1, 2025
1.2 years
October 7, 2020
January 31, 2025
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of CAP-1002: Incidence of All-Cause Mortality
Number of all-cause mortality cases from start of treatment up to end of study. Survival was measured as the time between the date of the start of treatment and the date of death.
Up to End of Study (Day 90)
Study Arms (2)
CAP-1002
ACTIVE COMPARATORThe active pharmaceutical ingredient in CAP-1002 is Cardiosphere-Derived Cells (CDCs). CDCs are known to secrete numerous bioactive elements (growth factors, exosomes) which impact the therapeutic benefits of the cell-based therapy. The mechanism of action is the composite ability to be immunomodulatory, anti-fibrotic, anti-inflammatory, and pro-angiogenic.
Placebo
PLACEBO COMPARATORMatching placebo solution
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects at least 18 years of age at time of consent.
- Diagnosis of SARS-CoV-2 infection confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay.
- Compromised respiratory status as defined by arterial oxygen saturation \< 92% (oxygen saturation measured by pulse oximetry) OR cardiomyopathy due to COVID-19 (defined as a new drop in ejection fraction to ≤ 50% during COVID-19 with no evidence of obstructive coronary artery disease based on medical records review).
- Elevation of at least 1 inflammatory marker (IL-1, IL-6, IL-10, TNF-α, ferritin, CRP) defined as ≥ 2x upper limit of laboratory normal reference value.
- Written informed consent provided by subject or legal representative.
You may not qualify if:
- Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV).
- Patients who have been intubated.
- Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia.
- Patients with untreated human immunodeficiency virus (HIV) infection.
- Creatinine clearance less than 30 mL/minute.
- Liver function tests \> 5x normal.
- Current or history (within the previous 5 years) of systemic autoimmune or connective tissue disease.
- Known allergy or hypersensitivity to any of the IP constituents such as dimethyl sulfoxide (DMSO) or bovine proteins.
- Treatment with a cell therapy product within 12 months prior to randomization.
- Participation in an ongoing protocol studying an experimental drug or device.
- Pregnant or breastfeeding female subjects, and sexually active female subjects of childbearing potential not willing to use contraceptive methods.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Capricor Inc.lead
Study Sites (4)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California Davis
Sacramento, California, 95817, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
PharmaTex Research, LLC
Amarillo, Texas, 79109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Awadalla
- Organization
- Capricor, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Tim Albertson, MD
UC Davis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Syringes (60-mL) with amber film-covered barrels
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2020
First Posted
November 10, 2020
Study Start
November 15, 2020
Primary Completion
February 4, 2022
Study Completion
February 4, 2022
Last Updated
February 20, 2025
Results First Posted
February 20, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share