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

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: Colchicine Tablets; Other: Current care per UCLA treating physicians

• Registration Number: NCT04355143
• Lead Sponsor: University of California, Los Angeles

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-21
• Study Start: 2020-05-01
• Primary Completion: 2021-07-21
• Study Completion: 2021-07-21
• Results First Submitted: 2022-07-19
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-01
• Last Update Submitted: 2022-11-01
• Results First Posted: 2022-11-03
• Last Update Posted: 2022-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine plus current care	Colchicine Tablets	Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine plus current care	Current care per UCLA treating physicians	Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Current care alone	Current care per UCLA treating physicians	Current care per UCLA physicians alone (control arm)

Primary Outcome Measures

Name	Time	Method
Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS)	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 Outcome Measures

Name	Time	Method
Delta (Peak Minus Baseline) Troponin Level	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
Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level	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
Change in Left Ventricular Ejection Fraction (LVEF) on Echocardiography	Baseline, Day 30	Number of participants experiencing LVEF of \< 50% on echocardiogram with failure to show an improvement of ≥ 5% at 30 days
Re-hospitalization at 90 Days	90 days	Number of participants released and re-admitted to the hospital within 90 days of enrollment
All-cause Mortality	90 days
Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level	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
Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level	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.
Composite Event-Free Survival Over Time (Days)	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
Number of Participants Requiring Mechanical Ventilation	90 days
Number of Participants Requiring Mechanical Circulatory Support (MCS)	90 days

Trial Locations

Locations (3)

UCLA Ronald Reagan Medical Center; 🇺🇸 Los Angeles, California, United States

UCLA Santa Monica Hospital; 🇺🇸 Santa Monica, California, United States

Miami Cardiac and Vascular Institutde, Baptist Health South Florida; 🇺🇸 Miami, Florida, United States