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

• Status: Suspended
• Trial end date: 2021-10-25
• Target enrollment: 0
• Participant gender: All

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 treating physicians alone (the control arm)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baptist Health South Florida
• Collaborator: University of California, Los Angeles
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• 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)

1. Elevated troponin level

2. Elevated BNP level

3. New ischemic or arrhythmogenic ECG/telemetry changes

4. New decrease in Left Ventricular Ejection Fraction (LVEF) or new pericardial effusion on echocardiogram

Exclusion Criteria:

• Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes:

1. Intrauterine devices (IUD), contraceptive implants, or tubal sterilization

2. Hormone method with a barrier method

3. Two barrier methods

4. 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