Status:
TERMINATED
Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)
Lead Sponsor:
Baptist Health South Florida
Collaborating Sponsors:
University of California, Los Angeles
Conditions:
Covid19
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
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 treat...
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 ...
Eligibility Criteria
Inclusion
- 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)
- Elevated troponin level
- Elevated BNP level
- New ischemic or arrhythmogenic ECG/telemetry changes
- New decrease in Left Ventricular Ejection Fraction (LVEF) or new pericardial effusion on echocardiogram
Exclusion
- Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes:
- Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
- Hormone method 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
- 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
Key Trial Info
Start Date :
December 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04762771
Start Date
December 23 2020
End Date
September 20 2021
Last Update
July 25 2022
Active Locations (1)
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1
Baptist Hospital of Miami
Miami, Florida, United States, 33176