Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Colchicine vs Current Standard of Care in Hospitalized Patients With COVID-19 and Cardiac Injury (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: NCT04510038
Recruitment Status : Suspended (Published RECOVERY trial provides evidence that further recruitment would not provide conclusive proof of worthwhile benefit of Colchicine on COVID patients.)
First Posted : August 12, 2020
Last Update Posted : August 23, 2021
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Raul Herrera, MD, Miami Cardiac and Vascular Institute

Tracking Information
First Submitted Date  ICMJE August 10, 2020
First Posted Date  ICMJE August 12, 2020
Last Update Posted Date August 23, 2021
Actual Study Start Date  ICMJE January 1, 2020
Actual Primary Completion Date March 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • All Cause Mortality [ Time Frame: 90 days ]
    Composite of all-cause mortality
  • Mechanical Ventilation [ Time Frame: 90 days ]
    Need for Mechanical Ventilation
  • Mechanical Circulatory Support [ Time Frame: 90 days ]
    Need for Mechanical Circulatory Support
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • Time to Deterioration [ Time Frame: 90 days ]
    Time to Primary Endpoint
  • Adverse Events [ Time Frame: 90 days ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
  • Troponin [ Time Frame: 90 days ]
    Peak Troponin Levels
  • Delta [ Time Frame: 90 days ]
    Troponin Levels Change from Baseline
  • BNP [ Time Frame: 90 days ]
    Change from Baseline on BNP levels
  • Changes in C Reactive Protein [ Time Frame: 90 days ]
    Changes from Baseline on C Reactive Protein
  • LOS [ Time Frame: 90 days ]
    Hospital Length of Stay
  • Re-Hospitalization [ Time Frame: 90 days ]
    Re-Hospitalization Rates
  • Changes in D Dimer [ Time Frame: 90 days ]
    Changes in D Dimer from Baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colchicine vs Current Standard of Care in Hospitalized Patients With COVID-19 and Cardiac Injury
Official Title  ICMJE Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)
Brief Summary Open-label randomized study comparing the current standard of care treatment of Covid-19 in hospitalized patients with evidence of cardiac injury vs. a group of the same type of patients treated with colchicine plus current standard of care.
Detailed Description

Myocardial injury has been described in up to 30% of COVID-19 infected patients, and portends a poor prognosis with currently no known treatment. Colchicine is a widely available, well-established, inexpensive, oral anti-inflammatory agent that has been FDA approved for the treatment of inflammatory disorders including gout and familial Mediterranean Fever. Trials have also shown its benefit to prevent post-cardiotomy syndrome, to treat acute and recurrent pericarditis, and reduce cardiovascular events after myocardial infarction. We extrapolate based on these indications and studies that colchicine may also help improve outcomes in hospitalized COVID-19 patients with evidence of cardiac injury.

This is an unblinded and randomized study comparing the treatment of colchicine plus current care (per institution treating physicians) as the active arm vs. current standard of care alone (per institution treating physicians) as the control arm.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Active group (Colchicine plus standard of care) vs Control group (standard of care alone)
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid19
  • Myocardial Injury
Intervention  ICMJE
  • Drug: Colchicine

    Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of CKD stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (AST/ALT > 3x normal).

    Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral

    Other Name: Colcrys
  • Other: Covid-19 Standard of Care
    As per treating physician
Study Arms  ICMJE
  • Experimental: Active Colchicine Arm
    Arm of Covid-19 hospitalized patients (with evidence of cardiac injury) treated with colchicine plus current standard of care.
    Interventions:
    • Drug: Colchicine
    • Other: Covid-19 Standard of Care
  • Active Comparator: Control Group
    Arm of Covid-19 hospitalized patients (with evidence of cardiac injury) treated with current standard of care only.
    Intervention: Other: Covid-19 Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: August 10, 2020)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Actual Primary Completion Date March 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and Women ≥ 18 years of age
  2. Cardiac injury (any of the following)

    1. Elevated troponin level
    2. Elevated BNP level
    3. New ischemic or arrhythmogenic ECG/telemetry changes
    4. New decrease in LVEF or new pericardial effusion on echocardiogram
  3. Able to provide informed consent

Exclusion Criteria:

  1. Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes:

    1. Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
    2. Hormone method with a barrier method
    3. Two barrier methods
    4. If a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction
  2. History of severe hematologic or neuromuscular disorder
  3. Co-administration of CYPA3A4 and P-glycoprotein transport inhibitor
  4. Severe renal impairment with concomitant hepatic impairment
  5. Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or hepatic impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04510038
Other Study ID Numbers  ICMJE 152247
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raul Herrera, MD, Miami Cardiac and Vascular Institute
Study Sponsor  ICMJE Miami Cardiac and Vascular Institute
Collaborators  ICMJE University of California, Los Angeles
Investigators  ICMJE
Principal Investigator: Sandra Chaparro, MD Baptist Health South Florida
Study Director: Raul E Herrera, MD Baptist Health South Florida
PRS Account Miami Cardiac and Vascular Institute
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP