Summary

Eligibility
for people ages 18-100 (full criteria)
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

Myocardial injury has been described in up to 30% of COVID-19 infected patients, and portends a poor prognosis with currently no known treatment. Colchicine is a widely available, well-established, inexpensive, oral anti-inflammatory agent that has been FDA approved for the treatment of inflammatory disorders including gout and familial Mediterranean Fever. Trials have also shown its benefit to prevent post-cardiotomy syndrome, to treat acute and recurrent pericarditis, and reduce cardiovascular events after myocardial infarction. We extrapolate based on these indications and studies that colchicine may also help improve outcomes in hospitalized COVID-19 patients with evidence of cardiac injury. This is an unblinded and randomized study comparing the treatment of colchicine plus current care (per institution treating physicians) as the active arm vs. current standard of care alone (per institution treating physicians) as the control arm.

Keywords

Covid19 Myocardial Injury Wounds and Injuries Colchicine

Eligibility

You can join if…

Open to people ages 18-100

  1. Men and Women ≥ 18 years of age
  2. Cardiac injury (any of the following)
  3. Elevated troponin level
  4. Elevated BNP level
  5. New ischemic or arrhythmogenic ECG/telemetry changes
  6. New decrease in LVEF or new pericardial effusion on echocardiogram
  7. Able to provide informed consent

You CAN'T join if...

  1. Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes:
  2. Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
  3. Hormone method with a barrier method
  4. Two barrier methods
  5. If a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction
  6. History of severe hematologic or neuromuscular disorder
  7. Co-administration of CYPA3A4 and P-glycoprotein transport inhibitor
  8. Severe renal impairment with concomitant hepatic impairment
  9. Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or hepatic impairment

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Miami Cardiac and Vascular Institute
ID
NCT04510038
Phase
Phase 2/3
Study Type
Interventional
Last Updated