Official Title
Randomized, Open-Label, Controlled Trial of Colchicine to Reduce Cardiac Injury in Hospitalized COVID-19 (Coronavirus Disease 2019) Patients (COLHEART-19)
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.

Status
Completed
Conditions
COVID-19
Interventions

Drug: Colchicine Tablets

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.
Other Name: Array

Other: Current care per UCLA treating physicians

Current care

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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

Investigators

Reza Ardehali, MD, PhD, Principal Investigator
University of California, Los Angeles

Sponsors / Collaborators
University of California, Los Angeles
NCT Number
NCT04355143
MeSH Terms
COVID-19
Colchicine