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

COVID-19 Clinical Trial

— COLHEART-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355143
• Other study ID #: 20-000685
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2020
• Est. completion date: July 21, 2021

Study information

• Verified date: November 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: July 21, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Colchicine Tablets
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:
• Current care per UCLA treating physicians
Current care

Locations

Country	Name	City	State
United States	UCLA Ronald Reagan Medical Center	Los Angeles	California
United States	Miami Cardiac and Vascular Institutde, Baptist Health South Florida	Miami	Florida
United States	UCLA Santa Monica Hospital	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS)	Number of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)	90 Days
Secondary	Delta (Peak Minus Baseline) Troponin Level	Change from initial troponin level to maximum level of troponin among measures taken during hospitalization and at 30 days	Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Secondary	Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level	Change from baseline BNP level (Day 1) to maximum level of BNP among measures taken during hospitalization and at 30 days	Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Secondary	Change in Left Ventricular Ejection Fraction (LVEF) on Echocardiography	Number of participants experiencing LVEF of < 50% on echocardiogram with failure to show an improvement of = 5% at 30 days	Baseline, Day 30
Secondary	Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level	Change from baseline CRP level (Day 1) to maximum level of CRP among measures taken during hospitalization and at 30 days	Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Secondary	Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level	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.	Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Secondary	Composite Event-Free Survival Over Time (Days)	Participants reaching primary (composite) endpoint were subtracted from event-free survival reported at 10-day intervals	Days 0, 10, 20, 30, 40, 50, 60, 70, 80, and 90
Secondary	Number of Participants Requiring Mechanical Ventilation		90 days
Secondary	Number of Participants Requiring Mechanical Circulatory Support (MCS)		90 days
Secondary	Re-hospitalization at 90 Days	Number of participants released and re-admitted to the hospital within 90 days of enrollment	90 days
Secondary	All-cause Mortality		90 days