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

University of California, Los Angeles93 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19

Interventions

Colchicine TabletsDRUG

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.

Current care per UCLA treating physiciansOTHER

Current care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

UCLA Ronald Reagan Medical Center

Los Angeles, California, United States

UCLA Santa Monica Hospital

Santa Monica, California, United States

Miami Cardiac and Vascular Institutde, Baptist Health South Florida

Miami, Florida, United States

Outcomes

Primary Outcomes

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)

Time frame: 90 Days

Secondary Outcomes

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

Time frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized

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

Time frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized

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

Time frame: Baseline, Day 30

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

Time frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized

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.

Data from ClinicalTrials.gov

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