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

University of California, Los Angeles (UCLA)

Status and phase

Completed

Phase 2

Conditions

COVID-19

Treatments

Other: Current care per UCLA treating physicians

Drug: Colchicine Tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT04355143

20-000685

Details and patient eligibility

About

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.

Enrollment

93 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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