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

Phase 1

Terminated

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)

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Active	Colchicine	Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians.

Primary Outcome Measures

Name	Time	Method
Mortality	90 days	Composite of all-cause mortality
Mechanical Ventilation	90 days	Need for mechanical ventilation
Mechanical Circulatory Support	90 days	Need for mechanical circulatory support

Secondary Outcome Measures

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