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Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19) (Colheart-19)

Primary Purpose

Covid19

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Colchicine
Sponsored by
Baptist Health South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and Women ≥ 18 years of age
  • Covid-19 Positive
  • Hospitalized patients able to provide informed consent

  • Cardiac injury (as evidenced by any of the following)

    1. Elevated troponin level
    2. Elevated BNP level
    3. New ischemic or arrhythmogenic ECG/telemetry changes
    4. New decrease in Left Ventricular Ejection Fraction (LVEF) or new pericardial effusion on echocardiogram

Exclusion Criteria:

  • 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
  • History of severe hematologic or neuromuscular disorder
  • Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein transport inhibitor
  • Severe renal impairment with concomitant hepatic impairment
  • Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or hepatic impairment

Sites / Locations

  • Baptist Hospital of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Active

Control

Arm Description

Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians.

Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.

Outcomes

Primary Outcome Measures

Mortality
Composite of all-cause mortality
Mechanical Ventilation
Need for mechanical ventilation
Mechanical Circulatory Support
Need for mechanical circulatory support

Secondary Outcome Measures

Time (Days) to the Primary End Point
Number of days from start of therapy to either mortality or need for Mechanical Ventilation or Mechanical Circulatory Support
Peak and Delta (Change From Baseline) Troponin Level
Change from baseline to the time when Troponin levels peak during the hospitalization
Baseline Brain Natriuretic Peptide (BNP) Level
Documenting baseline Brain Natriuretic Peptide (BNP) at the time of hospitalization
Inflammatory Biomarkers
Baseline and delta (change from baseline) of C-Reactive Protein
Hospital Length of Stay
Duration of Hospitalization on each arm
Need for Re-hospitalization
90-day re-hospitalization rate
Change in Inflammatory Biomarkers
Baseline and delta (change from baseline) of D-Dimer

Full Information

First Posted
February 18, 2021
Last Updated
July 21, 2022
Sponsor
Baptist Health South Florida
Collaborators
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04762771
Brief Title
Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)
Acronym
Colheart-19
Official Title
Open-label (Unblinded) Randomization to Treatment of Colchicine Plus Current Care Per Institution Treating Physicians vs. Current Care Per Institution Treating Physicians (Control Arm)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Recovery Trial showed no convincing evidence that further recruitment would provide conclusive proof of worthwhile benefit for the evaluation of Colchicine in patients with Covid-19.
Study Start Date
December 23, 2020 (Actual)
Primary Completion Date
May 12, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baptist Health South Florida
Collaborators
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is an open-label unblinded, randomized study to treat hospitalized covid-19 patients with colchicine plus current care (per institution treating physicians) vs. current care per institution treating physicians alone (the control arm)
Detailed Description
We aim to determine if Colchicine improves short-term outcomes in hospitalized coronavirus disease-19 (COVID-19) patients with cardiac manifestations of disease. 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 randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is an unblinded randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Description
Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
Intervention Type
Drug
Intervention Name(s)
Colchicine
Other Intervention Name(s)
Treatment with Colchicine plus standard of care in hospitalized patients with Covid-19
Intervention Description
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 chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase > 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
Primary Outcome Measure Information:
Title
Mortality
Description
Composite of all-cause mortality
Time Frame
90 days
Title
Mechanical Ventilation
Description
Need for mechanical ventilation
Time Frame
90 days
Title
Mechanical Circulatory Support
Description
Need for mechanical circulatory support
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Time (Days) to the Primary End Point
Description
Number of days from start of therapy to either mortality or need for Mechanical Ventilation or Mechanical Circulatory Support
Time Frame
90 days
Title
Peak and Delta (Change From Baseline) Troponin Level
Description
Change from baseline to the time when Troponin levels peak during the hospitalization
Time Frame
baseline and 90 days
Title
Baseline Brain Natriuretic Peptide (BNP) Level
Description
Documenting baseline Brain Natriuretic Peptide (BNP) at the time of hospitalization
Time Frame
baseline
Title
Inflammatory Biomarkers
Description
Baseline and delta (change from baseline) of C-Reactive Protein
Time Frame
baseline and 90 days
Title
Hospital Length of Stay
Description
Duration of Hospitalization on each arm
Time Frame
90 days
Title
Need for Re-hospitalization
Description
90-day re-hospitalization rate
Time Frame
90 days
Title
Change in Inflammatory Biomarkers
Description
Baseline and delta (change from baseline) of D-Dimer
Time Frame
baseline and 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and Women ≥ 18 years of age Covid-19 Positive Hospitalized patients able to provide informed consent Cardiac injury (as evidenced by any of the following) Elevated troponin level Elevated BNP level New ischemic or arrhythmogenic ECG/telemetry changes New decrease in Left Ventricular Ejection Fraction (LVEF) or new pericardial effusion on echocardiogram Exclusion Criteria: Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes: Intrauterine devices (IUD), contraceptive implants, or tubal sterilization Hormone method 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 History of severe hematologic or neuromuscular disorder Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein transport inhibitor Severe renal impairment with concomitant hepatic impairment Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or hepatic impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Chaparro, MD
Organizational Affiliation
Baptist Health South Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raul E Herrera, MD
Organizational Affiliation
Baptist Health South Florida
Official's Role
Study Director
Facility Information:
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34658014
Citation
Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.
Results Reference
derived

Learn more about this trial

Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)

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