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

Phase 2TerminatedNCT04762771

Baptist Health South Florida2 enrolled

Overview

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)

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid19

Interventions

ColchicineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Baptist Hospital of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Mortality

Composite of all-cause mortality

Time frame: 90 days

Mechanical Ventilation

Need for mechanical ventilation

Time frame: 90 days

Mechanical Circulatory Support

Need for mechanical circulatory support

Time frame: 90 days

Secondary Outcomes

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

Time frame: 90 days

Peak and Delta (Change From Baseline) Troponin Level

Change from baseline to the time when Troponin levels peak during the hospitalization

Time frame: baseline and 90 days

Baseline Brain Natriuretic Peptide (BNP) Level

Documenting baseline Brain Natriuretic Peptide (BNP) at the time of hospitalization

Time frame: baseline

Inflammatory Biomarkers

Baseline and delta (change from baseline) of C-Reactive Protein

Time frame: baseline and 90 days

Hospital Length of Stay

Duration of Hospitalization on each arm

Time frame: 90 days

Need for Re-hospitalization

Data from ClinicalTrials.gov

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