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A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Intravenous Delivery of CAP-1002 in Patients With Severe COVID-19

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Intravenous Delivery of CAP-1002 in Patients With Severe COVID-19

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 28 May 2020

At a glance

  • Drugs CAP-1002 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Expanded access; Therapeutic Use
  • Sponsors Capricor
  • Most Recent Events

    • 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.
    • 07 Apr 2020 New trial record

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 -

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. Diagnosis of SARS-CoV-2 infection confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay 3. Compromised respiratory status as defined by the below criteria to maintain arterial oxygen saturation ≥ 92%, where oxygen saturation is assessed 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 artery disease based on medical record review): 1. Patients requiring mechanical invasive intubation, 2. Patients requiring noninvasive positive pressure ventilation, 3. Patients on non-rebreather face masks or high-flow nasal canula (flow ≥ 6 L/min or FiO2 ≥ 40%) 4. Elevation of at least 1 inflammatory biomarker (IL-1, IL-6, IL-10, TNF-α, ferritin, CRP) defined as ≥ 2x the upper limit of the laboratory reference value 5. Written informed consent provided by the subject or legal representative

Patient Exclusion Criteria

1. Currently receiving extracorporeal membrane oxygenation (ECMO) or high frequency oscillatory ventilation (HFOV) 2. Patients with established positive bacterial blood cultures prior to enrollment or suspicion of superimposed bacterial pneumonia 3. Patients with untreated HIV infection 4. Creatinine clearance less than 30 ml/minute 5. LFTs > 5x normal 6. Current or history (within the previous 5 years) of systemic autoimmune or connective tissue disease 7. Known allergy or hypersensitivity to any of the investigational product constituents such as dimethyl sulfoxide (DMSO) or bovine proteins 8. Treatment with a cell therapy product within 12 months prior to randomization 9. Pregnant or breastfeeding at screening

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

COVID-2019 infections
Results from the compassionate care program for CAP 1002, demonstrated 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

COVID-2019 infections
Results from the compassionate care program, reported no adverse events related to the administration of CAP 1002 [1] .

Publications

  1. Capricor Therapeutics. New Capricor Data Reports 100 Percent Survival in Critical COVID-19 Patients Treated with CAP-1002. Media-Rel 2020;.

    Media Release
  2. Capricor Therapeutics. Capricor Initiates Compassionate Use Program for Severe COVID-19 Patients using CAP-1002, its Novel Cell Therapy. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Capricor Therapeutics 2 2 2

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
Paula Williams, MS
646-784-7030
pwilliams@capricor.com
show details
Capricor Inc.
-
Raj Makkar, MD Cedars-Sinai Medical Center, Los Angeles, CA 90048
-
Siegfried Rogy, PhD
818-618-5774
srogy@capricor.com
show details
Capricor Inc.
-

Centres

Centre Name Location Trial Centre Country
Capricor Inc.
-
-
Cedars-Sinai Medical Center Los Angeles, California USA
Cedars-Sinai Medical Center, Los Angeles, CA 90048
-
-

Trial History

Event Date Event Type Comment
28 May 2020 Other trial event Last checked against Clinicaltrials.gov record. Updated 28 May 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

References

  1. Capricor Therapeutics. New Capricor Data Reports 100 Percent Survival in Critical COVID-19 Patients Treated with CAP-1002. Media-Rel 2020;.

    Media Release
  2. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  3. 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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