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)
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)

Terminated
COVID19

Drug: Colchicine

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
Other Name: Treatment with Colchicine plus standard of care in hospitalized patients with Covid-19

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)

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 99 Years
Countries
United States
Locations

Baptist Hospital of Miami
Miami, Florida, United States

University of California, Los Angeles
NCT Number
MeSH Terms
COVID-19
Colchicine