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Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19) (COLHEART-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355143
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Los Angeles

Brief Summary:
Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm). Importantly, this adaptive trial design allows for patients in either study arm to receive other investigational drugs for COVID-19 as new science emerges.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Colchicine Tablets Other: Current care per UCLA treating physicians Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Random assignment to study arms in a 1:1 ratio
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open-Label, Controlled Trial of Colchicine to Reduce Cardiac Injury in Hospitalized COVID-19 Patients (COLHEART-19)
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : April 25, 2021
Estimated Study Completion Date : April 25, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: Colchicine plus current care
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Drug: Colchicine Tablets
COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Other Names:
  • COLCRYS
  • AR 374

Other: Current care per UCLA treating physicians
Current care

Active Comparator: Current care alone
Current care per UCLA physicians alone (control arm)
Other: Current care per UCLA treating physicians
Current care




Primary Outcome Measures :
  1. Composite of all-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS) [ Time Frame: 90 Days ]
    Number of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)


Secondary Outcome Measures :
  1. Delta (peak minus baseline) troponin level [ Time Frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized ]
    Change from initial troponin level to maximum level of troponin among measures taken during hospitalization and at 30 days

  2. Delta (baseline to peak) brain natriuretic peptide (BNP) level [ Time Frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized ]
    Change from baseline BNP level (Day 1) to maximum level of BNP among measures taken during hospitalization and at 30 days

  3. Change in left ventricular ejection fraction (LVEF) on echocardiography [ Time Frame: Baseline, Day 30 ]
    Number of participants experiencing LVEF of < 50% on echocardiogram with failure to show an improvement of ≥ 5% at 30 days

  4. Delta (peak minus baseline) C-Reactive protein (CRP) inflammatory biomarker level [ Time Frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized ]
  5. Delta (peak minus baseline) D-Dimer inflammatory biomarker level [ Time Frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized ]
    D-Dimer is a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis, so named because it contains two D fragments of the fibrin protein joined by a cross-link

  6. Time (days) to primary endpoint [ Time Frame: up to 90 days ]
  7. Number of participants requiring mechanical ventilation [ Time Frame: 90 days ]
  8. Number of participants requiring mechanical circulatory support (MCS) [ Time Frame: 90 days ]
  9. Re-hospitalization at 90 days [ Time Frame: 90 days ]
    Number of participants released and re-admitted to the hospital within 90 days of enrollment

  10. All-cause mortality [ Time Frame: 90 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed COVID-19 infection by polymerase chain reaction
  • Cardiac injury, including any of the following:

    • Elevated troponin level
    • Elevated B-type natriuretic peptide (BNP) level
    • New ischemic or arrhythmogenic changes on ECG/telemetry
    • New decrease in left ventricular ejection fraction (LVEF) or new pericardial effusion on echocardiogram
  • Able to provide informed consent

Exclusion Criteria:

  • Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use 2 forms of contraception, which includes:

    • Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
    • Hormone methods with a barrier method
    • Two barrier methods
    • If a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction
  • Co-administration of CYPA3A4 and P-glycoprotein (P-gp) transport system inhibitors
  • Concurrent use of strong CYP3A4 or P-gp inhibitors in patients with renal or hepatic impairment;
  • Severe hematologic or neuaromuscular disorders
  • Severe renal impairmant with concomitant hepatic impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04355143


Contacts
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Contact: Amir B Rabbani, MD 310-517-8578 arabbani@mednet.ucla.edu
Contact: Reza Ardehali, MD, PhD 310-825-9011 rardehali@mednet.ucla.edu

Locations
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United States, California
UCLA Ronald Reagan Medical Center Recruiting
Los Angeles, California, United States, 90095
UCLA Santa Monica Hospital Recruiting
Santa Monica, California, United States, 90404
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Reza Ardehali, MD, PhD University of California, Los Angeles
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Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04355143    
Other Study ID Numbers: 20-000685
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents