Colchicine vs Current Standard of Care in Hospitalized Patients With COVID-19 and Cardiac Injury

• Status: Suspended
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Open-label randomized study comparing the current standard of care treatment of Covid-19 in hospitalized patients with evidence of cardiac injury vs. a group of the same type of patients treated with colchicine plus current standard of care.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Miami Cardiac and Vascular Institute
• Collaborator: University of California, Los Angeles
• Treatments: Colchicine

Criteria

Inclusion Criteria:

1. Men and Women ≥ 18 years of age

2. Cardiac injury (any of the following)

1. Elevated troponin level

2. Elevated BNP level

3. New ischemic or arrhythmogenic ECG/telemetry changes

4. New decrease in LVEF or new pericardial effusion on echocardiogram

3. Able to provide informed consent

Exclusion Criteria:

1. 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

2. History of severe hematologic or neuromuscular disorder

3. Co-administration of CYPA3A4 and P-glycoprotein transport inhibitor

4. Severe renal impairment with concomitant hepatic impairment

5. Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or hepatic impairment