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

NCT04355143 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 20-000685
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Delta (Peak Minus Baseline) Troponin Level

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

• Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level

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

• Change in Left Ventricular Ejection Fraction (LVEF) on Echocardiography

  Baseline, Day 30

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

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

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

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

Study Arms (2)

Colchicine plus current care

EXPERIMENTAL

Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians

Drug: Colchicine Tablets; Other: Current care per UCLA treating physicians

Current care alone

ACTIVE COMPARATOR

Current care per UCLA physicians alone (control arm)

Other: Current care per UCLA treating physicians

Interventions

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.

Also known as: COLCRYS, AR 374

Colchicine plus current care

Current care per UCLA treating physicians OTHER

Current care

Colchicine plus current care; Current care alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (3)

UCLA Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

Location

UCLA Santa Monica Hospital

Santa Monica, California, 90404, United States

Location

Miami Cardiac and Vascular Institutde, Baptist Health South Florida

Miami, Florida, 33176, United States

Location

Related Publications (2)

• Rabbani A, Rafique A, Wang X, Campbell D, Wang D, Brownell N, Capdevilla K, Garabedian V, Chaparro S, Herrera R, Parikh RV, Ardehali R. Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With Coronavirus Disease-19. Front Cardiovasc Med. 2022 Jun 17;9:876718. doi: 10.3389/fcvm.2022.876718. eCollection 2022.

  PMID: 35783822 DERIVED

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Reza Ardehali, MD, PhD
• Organization: University of California Los Angeles

rardehali@mednet.ucla.edu

310-825-5280

Study Officials

• Reza Ardehali, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random assignment to study arms in a 1:1 ratio

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 21, 2020
• Study Start: May 1, 2020
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: November 3, 2022
• Results First Posted: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)