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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Colchicine Tablets
Current care per UCLA treating physicians
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

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

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

Sites / Locations

  • UCLA Ronald Reagan Medical Center
  • UCLA Santa Monica Hospital
  • Miami Cardiac and Vascular Institutde, Baptist Health South Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Colchicine plus current care

Current care alone

Arm Description

Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians

Current care per UCLA physicians alone (control arm)

Outcomes

Primary Outcome Measures

Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS)
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

Delta (Peak Minus Baseline) Troponin Level
Change from initial troponin level to maximum level of troponin among measures taken during hospitalization and at 30 days
Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level
Change from baseline BNP level (Day 1) to maximum level of BNP among measures taken during hospitalization and at 30 days
Change in Left Ventricular Ejection Fraction (LVEF) on Echocardiography
Number of participants experiencing LVEF of < 50% on echocardiogram with failure to show an improvement of ≥ 5% at 30 days
Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level
Change from baseline CRP level (Day 1) to maximum level of CRP among measures taken during hospitalization and at 30 days
Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level
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.
Composite Event-Free Survival Over Time (Days)
Participants reaching primary (composite) endpoint were subtracted from event-free survival reported at 10-day intervals
Number of Participants Requiring Mechanical Ventilation
Number of Participants Requiring Mechanical Circulatory Support (MCS)
Re-hospitalization at 90 Days
Number of participants released and re-admitted to the hospital within 90 days of enrollment
All-cause Mortality

Full Information

First Posted
April 14, 2020
Last Updated
November 1, 2022
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04355143
Brief Title
Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)
Acronym
COLHEART-19
Official Title
Randomized, Open-Label, Controlled Trial of Colchicine to Reduce Cardiac Injury in Hospitalized COVID-19 (Coronavirus Disease 2019) Patients (COLHEART-19)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
July 21, 2021 (Actual)
Study Completion Date
July 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Random assignment to study arms in a 1:1 ratio
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colchicine plus current care
Arm Type
Experimental
Arm Description
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Arm Title
Current care alone
Arm Type
Active Comparator
Arm Description
Current care per UCLA physicians alone (control arm)
Intervention Type
Drug
Intervention Name(s)
Colchicine Tablets
Other Intervention Name(s)
COLCRYS, AR 374
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Current care per UCLA treating physicians
Intervention Description
Current care
Primary Outcome Measure Information:
Title
Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS)
Description
Number of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Delta (Peak Minus Baseline) Troponin Level
Description
Change from initial troponin level to maximum level of troponin among measures taken during hospitalization and at 30 days
Time Frame
Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Title
Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level
Description
Change from baseline BNP level (Day 1) to maximum level of BNP among measures taken during hospitalization and at 30 days
Time Frame
Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Title
Change in Left Ventricular Ejection Fraction (LVEF) on Echocardiography
Description
Number of participants experiencing LVEF of < 50% on echocardiogram with failure to show an improvement of ≥ 5% at 30 days
Time Frame
Baseline, Day 30
Title
Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level
Description
Change from baseline CRP level (Day 1) to maximum level of CRP among measures taken during hospitalization and at 30 days
Time Frame
Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Title
Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level
Description
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.
Time Frame
Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Title
Composite Event-Free Survival Over Time (Days)
Description
Participants reaching primary (composite) endpoint were subtracted from event-free survival reported at 10-day intervals
Time Frame
Days 0, 10, 20, 30, 40, 50, 60, 70, 80, and 90
Title
Number of Participants Requiring Mechanical Ventilation
Time Frame
90 days
Title
Number of Participants Requiring Mechanical Circulatory Support (MCS)
Time Frame
90 days
Title
Re-hospitalization at 90 Days
Description
Number of participants released and re-admitted to the hospital within 90 days of enrollment
Time Frame
90 days
Title
All-cause Mortality
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Ardehali, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Ronald Reagan Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Santa Monica Hospital
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Miami Cardiac and Vascular Institutde, Baptist Health South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35783822
Citation
Rabbani A, Rafique A, Wang X, Campbell D, Wang D, Brownell N, Capdevilla K, Garabedian V, Chaparro S, Herrera R, Parikh RV, Ardehali R. Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With Coronavirus Disease-19. Front Cardiovasc Med. 2022 Jun 17;9:876718. doi: 10.3389/fcvm.2022.876718. eCollection 2022.
Results Reference
derived
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived

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

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