Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Reza Ardehali, MD, PhD (ucla)

Description

Summary

Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm). Importantly, this adaptive trial design allows for patients in either study arm to receive other investigational drugs for COVID-19 as new science emerges.

Official Title

Randomized, Open-Label, Controlled Trial of Colchicine to Reduce Cardiac Injury in Hospitalized COVID-19 Patients (COLHEART-19)

Keywords

COVID-19 Colchicine Colchicine Tablets Current care per UCLA treating physicians

Eligibility

You can join if…

Open to people ages 18 years and up

  • Confirmed COVID-19 infection by polymerase chain reaction
  • Cardiac injury, including any of the following:
  • Elevated troponin level
  • Elevated B-type natriuretic peptide (BNP) level
  • New ischemic or arrhythmogenic changes on ECG/telemetry
  • New decrease in left ventricular ejection fraction (LVEF) or new pericardial effusion on echocardiogram
  • Able to provide informed consent

You CAN'T join if...

  • Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use 2 forms of contraception, which includes:
  • Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
  • Hormone methods 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
  • Co-administration of CYPA3A4 and P-glycoprotein (P-gp) transport system inhibitors
  • Concurrent use of strong CYP3A4 or P-gp inhibitors in patients with renal or hepatic impairment;
  • Severe hematologic or neuaromuscular disorders
  • Severe renal impairmant with concomitant hepatic impairment

Locations

  • UCLA Ronald Reagan Medical Center accepting new patients
    Los Angeles California 90095 United States
  • UCLA Santa Monica Hospital accepting new patients
    Santa Monica California 90404 United States

Lead Scientist at UC Health

  • Reza Ardehali, MD, PhD (ucla)
    Associate Professor-in-Residence, Medicine. Authored (or co-authored) 57 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04355143
Phase
Phase 2
Study Type
Interventional
Last Updated