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

• Status: Active, not recruiting
• Trial end date: 2021-09-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Colchicine

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 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 neuaromuscular disorders

• Severe renal impairmant with concomitant hepatic impairment