Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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. 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: NCT04510038
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Raul Herrera, MD, Miami Cardiac and Vascular Institute

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.

Condition or disease Intervention/treatment Phase
Covid19 Myocardial Injury Drug: Colchicine Other: Covid-19 Standard of Care Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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
Official Title: Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: Active Colchicine Arm
Arm of Covid-19 hospitalized patients (with evidence of cardiac injury) treated with colchicine plus current standard of care.
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

Active Comparator: Control Group
Arm of Covid-19 hospitalized patients (with evidence of cardiac injury) treated with current standard of care only.
Other: Covid-19 Standard of Care
As per treating physician




Primary Outcome Measures :
  1. All Cause Mortality [ Time Frame: 90 days ]
    Composite of all-cause mortality

  2. Mechanical Ventilation [ Time Frame: 90 days ]
    Need for Mechanical Ventilation

  3. Mechanical Circulatory Support [ Time Frame: 90 days ]
    Need for Mechanical Circulatory Support


Secondary Outcome Measures :
  1. Time to Deterioration [ Time Frame: 90 days ]
    Time to Primary Endpoint

  2. Adverse Events [ Time Frame: 90 days ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".

  3. Troponin [ Time Frame: 90 days ]
    Peak Troponin Levels

  4. Delta [ Time Frame: 90 days ]
    Troponin Levels Change from Baseline

  5. BNP [ Time Frame: 90 days ]
    Change from Baseline on BNP levels

  6. Changes in C Reactive Protein [ Time Frame: 90 days ]
    Changes from Baseline on C Reactive Protein

  7. LOS [ Time Frame: 90 days ]
    Hospital Length of Stay

  8. Re-Hospitalization [ Time Frame: 90 days ]
    Re-Hospitalization Rates

  9. Changes in D Dimer [ Time Frame: 90 days ]
    Changes in D Dimer from Baseline



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04510038


Contacts
Layout table for location contacts
Contact: Raul E Herrera, MD 786-596-3505 raulh@baptisthealth.net
Contact: Sandra Chaparro, MD 786-596-3505 sandraCH@Baptisthealth.net

Sponsors and Collaborators
Miami Cardiac and Vascular Institute
University of California, Los Angeles
Investigators
Layout table for investigator information
Principal Investigator: Sandra Chaparro, MD Baptist Health South Florida
Study Director: Raul E Herrera, MD Baptist Health South Florida
Layout table for additonal information
Responsible Party: Raul Herrera, MD, Director Miami Cardiac and Vascular Institute, Research and Outcomes, Miami Cardiac and Vascular Institute
ClinicalTrials.gov Identifier: NCT04510038    
Other Study ID Numbers: 152247
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents