A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Intravenous Delivery of CAP-1002 in Patients With Severe COVID-19
Latest Information Update: 04 Nov 2021
At a glance
- Drugs CAP-1002 (Primary)
- Indications COVID 2019 infections; Respiratory tract infections
- Focus Adverse reactions; Expanded access; Therapeutic Use
- Sponsors Capricor
- 07 Oct 2020 Status changed from recruiting to completed.
- 29 Apr 2020 Results (n=6) presented in the Capricor Therapeutics media release.
- 29 Apr 2020 According to a Capricor Therapeutics media release, the U.S. Food and Drug Administration (FDA) approved the Company's expanded access protocol to treat up to 20 additional COVID-19 patients. Data (n=6) from this trial has been submitted for publication.
Most Recent Events
Trial Overview
Purpose
This randomized, double-blind, placebo-controlled trial will enroll subjects with a clinical diagnosis of COVID-19 confirmed by laboratory testing.
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
COVID 2019 infections | treatment | - |
Respiratory tract infections | treatment | - |
Biomarker
NCT Number | Biomarker Name | Biomarker Function |
---|---|---|
NCT04338347 | BNP | Detailed Description |
C-reactive protein (CRP) | Detailed Description, Eligibility Criteria | |
Cardiac Troponin I | Eligibility Criteria | |
Cardiac Troponin T | Detailed Description, Eligibility Criteria | |
Estrogen receptor alpha (ER alpha) | Detailed Description | |
Interleukin-6 (IL-6) | Eligibility Criteria | |
myoglobin | Eligibility Criteria |
Subjects
- Subject Type patients
- Sex male & female
- Age Group ≥ 18 years; adult
Patient Inclusion Criteria
1. Male or female subjects at least 18 years of age at time of consent 2. Confirmed COVID-19 infection by clinical diagnosis and laboratory testing 3. In critical condition as indicated by life support measurements 4. 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)
Patient Exclusion Criteria
1. Male or female subjects at least 18 years of age at time of consent 2. Confirmed COVID-19 infection by clinical diagnosis and laboratory testing 3. In critical condition as indicated by life support measurements 4. 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)
Trial Details
Identifiers
Identifier | Owner |
---|---|
NCT04338347 | ClinicalTrials.gov: US National Institutes of Health |
CAP1002COVID19 | - |
Organisations
- Sponsors Capricor
- Affiliations Capricor; Capricor Therapeutics
Trial Dates
Other Details
- Design double-blind; prospective; randomised
- Phase of Trial Clinical Phase Unknown
- Location USA
- Focus Adverse reactions; Expanded access; Therapeutic Use
Interventions
Drugs | Route | Formulation |
---|---|---|
CAP-1002Primary Drug | Intravenous | Infusion |
Biological: CAP-1002 Allogeneic Cardiosphere-Derived Cells (Extracellular Vesicles (EVs) from Cardiosphere-Derived Cells (CDCs))
Results
Therapeutic efficacy
Updated results from the from the compassionate care programme for CAP 1002 showed that of the seven patients hospitalized with severe COVID-2019 infection, six were on ventilator support. All patients were treated with CAP 1002. Four of the seven patients were fully discharged and three died between one- and two-months post-treatment. Earlier results from the compassionate care programme had demonstrated that of the five patients on ventilator support, four patients no longer required ventilator support within just one to four days following the infusion. The fifth patient remained on mechanical ventilation and the sixth patient received supplemental oxygen and clinically stable. Following infusion, several patients showed improvements in biomarkers, such as ferritin, absolute lymphocyte counts and CRP. Five male patients and one female patient (between ages 19 and 75) suffering from COVID-19 received IV infusions of 150 million allogeneic cardiosphere-derived cells CAP 1002 [1] .
Adverse events
Results from the compassionate care program, reported no adverse events related to the administration of CAP 1002 [1] .
Pharmacokinetics
COVID-2019 infections
Results from the from the compassionate care programme for CAP 1002 showed that the treatment caused a decrease in the white blood cell count, IL-6 levels, C-reactive protein, and/or reduced reliance on supplemental oxygen. The patients had received IV infusions of 150 million allogeneic cardiosphere-derived cells CAP 1002.
Publications
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Capricor Therapeutics. New Capricor Data Reports 100 Percent Survival in Critical COVID-19 Patients Treated with CAP-1002. Media-Rel 2020;.
Media Release -
Capricor Therapeutics. Capricor Initiates Compassionate Use Program for Severe COVID-19 Patients using CAP-1002, its Novel Cell Therapy. Media-Rel 2020;.
Media Release
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Khaled Alsabaawi
310-423-6226 Khaled.Alsabaawi@cshs.org
show details
|
Cedars-Sinai Medical Center | USA |
Larry Larscheid, BS
310-358-3200 clinicalresearch@capricor.com
show details
|
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|
Paula Williams, MS
646-784-7030
show details
pwilliams@capricor.com |
Capricor Inc. |
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|
Raj Makkar, MD | Cedars-Sinai Medical Center, Los Angeles, CA 90048 |
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|
Siegfried Rogy, PhD
310-358-3200 clinicalresearch@capricor.com
show details
|
, Capricor Inc. |
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|
Tarun Chakravarty, MD | Cedars-Sinai Medical Center | USA |
Centres
Centre Name | Location | Trial Centre Country |
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- |
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Capricor Inc. |
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Cedars-Sinai Medical Center | Los Angeles, California | USA |
Cedars-Sinai Medical Center, Los Angeles, CA 90048 |
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Trial History
Event Date | Event Type | Comment |
---|---|---|
01 Dec 2020 | Biomarker Update | Biomarkers information updated Updated 04 Nov 2021 |
30 Nov 2020 | Other trial event | Last checked against Clinicaltrials.gov record. Updated 30 Nov 2020 |
07 Oct 2020 | Status change - completed | Status changed from recruiting to completed. Updated 09 Oct 2020 |
29 Apr 2020 | Results | Results (n=6) presented in the Capricor Therapeutics media release. Updated 04 May 2020 |
29 Apr 2020 | Other trial event | According to a Capricor Therapeutics media release, the U.S. Food and Drug Administration (FDA) approved the Company's expanded access protocol to treat up to 20 additional COVID-19 patients. Data (n=6) from this trial has been submitted for publication. Updated 04 May 2020 |
09 Apr 2020 | Other trial event | New source identified and integrated (ClinicalTrials.gov, NCT04338347). Updated 09 Apr 2020 |
07 Apr 2020 | New trial record | New trial record Updated 07 Apr 2020 |
03 Apr 2020 | Other trial event | According to an Capricor Therapeutics media release, the company has submitted an expanded access Investigational New Drug (IND) application to investigate the use of CAP-1002 in certain COVID-19 patients which is currently under review with the FDA. Updated 07 Apr 2020 |
03 Apr 2020 | Results | Results published in the Capricor Therapeutics Media Release. Updated 07 Apr 2020 |
03 Apr 2020 | Other trial event | According to an Capricor Therapeutics media release, the company announced that it is providing CAP-1002, its novel cell therapy to patients with advanced COVID-19 under the compassionate use pathway. Two patients were treated last week at a leading healthcare center in Los Angeles, California with additional patients planned in the coming weeks. Updated 07 Apr 2020 |
Table of Contents
References
-
Capricor Therapeutics. New Capricor Data Reports 100 Percent Survival in Critical COVID-19 Patients Treated with CAP-1002. Media-Rel 2020;.
Media Release -
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Capricor Therapeutics. Capricor Initiates Compassionate Use Program for Severe COVID-19 Patients using CAP-1002, its Novel Cell Therapy. Media-Rel 2020;.
Media Release
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