Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)

Stopped early · Phase 1/Phase 2

Conditions studied: Covid19

In brief

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 treating physicians alone (the control arm)

Key facts

Study ID: NCT04762771
Run by: Baptist Health South Florida
People needed: 2
Starts: 2020-12-23
Expected to finish: 2021-09-20
Last updated by the study team: 2022-07-25

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Baptist Hospital of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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