Skip to main content
OpenTrials
Completed

NCT Number: NCT04355143

Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCLA Ronald Reagan Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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 Cytochrome P450 3A4 (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 neuromuscular disorders
  • Severe renal impairment with concomitant hepatic impairment

Treatment and study plan

Colchicine Tablets

Drug

COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.

Other names: COLCRYS, AR 374

Current care per UCLA treating physicians

Other

Current care

Primary outcomes

  1. Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS)

    Time frame: 90 Days

    Number of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)

Secondary outcomes

  1. Delta (Peak Minus Baseline) Troponin Level

    Time frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized

    Change from initial troponin level to maximum level of troponin among measures taken during hospitalization and at 30 days

  2. Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level

    Time frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized

    Change from baseline BNP level (Day 1) to maximum level of BNP among measures taken during hospitalization and at 30 days

  3. Change in Left Ventricular Ejection Fraction (LVEF) on Echocardiography

    Time frame: Baseline, Day 30

    Number of participants experiencing LVEF of < 50% on echocardiogram with failure to show an improvement of ≥ 5% at 30 days

  4. Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level

    Time frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized

    Change from baseline CRP level (Day 1) to maximum level of CRP among measures taken during hospitalization and at 30 days

  5. Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level

    Time frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized

    Change from baseline D-Dimer level (Day 1) to maximum level among measures taken during hospitalization and at 30 days. D-Dimer is a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis, so named because it contains two D fragments of the fibrin protein joined by a cross-link.

  6. Composite Event-Free Survival Over Time (Days)

    Time frame: Days 0, 10, 20, 30, 40, 50, 60, 70, 80, and 90

    Participants reaching primary (composite) endpoint were subtracted from event-free survival reported at 10-day intervals

  7. Number of Participants Requiring Mechanical Ventilation

    Time frame: 90 days

  8. Number of Participants Requiring Mechanical Circulatory Support (MCS)

    Time frame: 90 days

  9. Re-hospitalization at 90 Days

    Time frame: 90 days

    Number of participants released and re-admitted to the hospital within 90 days of enrollment

  10. All-cause Mortality

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Randomized, Open-Label, Controlled Trial of Colchicine to Reduce Cardiac Injury in Hospitalized COVID-19 (Coronavirus Disease 2019) Patients (COLHEART-19)

Acronym: COLHEART-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2020
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.