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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355143
Recruitment Status : Completed
First Posted : April 21, 2020
Results First Posted : November 3, 2022
Last Update Posted : November 3, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, Los Angeles

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 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 (Coronavirus Disease 2019) Patients (COLHEART-19)
Actual Study Start Date : May 1, 2020
Actual Primary Completion Date : July 21, 2021
Actual Study Completion Date : July 21, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arms and Interventions
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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


Outcome Measures
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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 ]
    Change from baseline CRP level (Day 1) to maximum level of CRP among measures taken during hospitalization and at 30 days

  5. Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level [ Time Frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized ]
    Change from baseline D-Dimer level (Day 1) to maximum level among measures taken during hospitalization and at 30 days. 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. Composite Event-Free Survival Over Time (Days) [ Time Frame: Days 0, 10, 20, 30, 40, 50, 60, 70, 80, and 90 ]
    Participants reaching primary (composite) endpoint were subtracted from event-free survival reported at 10-day intervals

  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 ]

Eligibility Criteria
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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 Cytochrome P450 3A4 (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 neuromuscular disorders
  • Severe renal impairment with concomitant hepatic impairment
Contacts and Locations
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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


Locations
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United States, California
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
UCLA Santa Monica Hospital
Santa Monica, California, United States, 90404
United States, Florida
Miami Cardiac and Vascular Institutde, Baptist Health South Florida
Miami, Florida, United States, 33176
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Reza Ardehali, MD, PhD University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by University of California, Los Angeles:
Study Protocol  [PDF] June 5, 2020
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Results First Posted: November 3, 2022
Last Update Posted: November 3, 2022
Last Verified: November 2022
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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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents