Status:
COMPLETED
Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)
Lead Sponsor:
University of California, Los Angeles
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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, t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2021
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT04355143
Start Date
May 1 2020
End Date
July 21 2021
Last Update
November 3 2022
Active Locations (3)
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1
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
2
UCLA Santa Monica Hospital
Santa Monica, California, United States, 90404
3
Miami Cardiac and Vascular Institutde, Baptist Health South Florida
Miami, Florida, United States, 33176