Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)

NCT04762771 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 152247
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label unblinded, randomized study to treat hospitalized covid-19 patients with colchicine plus current care (per institution treating physicians) vs. current care per institution treating physicians alone (the control arm)

Conditions

Covid19

Outcome Measures

Primary Outcomes (3)

• Mortality

  Composite of all-cause mortality

  90 days

• Mechanical Ventilation

  Need for mechanical ventilation

  90 days

• Mechanical Circulatory Support

  Need for mechanical circulatory support

  90 days

Secondary Outcomes (7)

• Time (Days) to the Primary End Point

  90 days

• Peak and Delta (Change From Baseline) Troponin Level

  baseline and 90 days

• Baseline Brain Natriuretic Peptide (BNP) Level

  baseline

• Inflammatory Biomarkers

  baseline and 90 days

• Hospital Length of Stay

  90 days

Study Arms (2)

Active

ACTIVE COMPARATOR

Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians.

Drug: Colchicine

Control

NO INTERVENTION

Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.

Interventions

Colchicine DRUG

Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral

Also known as: Treatment with Colchicine plus standard of care in hospitalized patients with Covid-19

Active

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women ≥ 18 years of age
• Covid-19 Positive
• Hospitalized patients able to provide informed consent
• Cardiac injury (as evidenced by any of the following)
• Elevated troponin level
• Elevated BNP level
• New ischemic or arrhythmogenic ECG/telemetry changes
• New decrease in Left Ventricular Ejection Fraction (LVEF) or new pericardial effusion on echocardiogram

You may not qualify if:

• Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes:
• Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
• Hormone method 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
• History of severe hematologic or neuromuscular disorder
• Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein transport inhibitor
• Severe renal impairment with concomitant hepatic impairment
• Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or hepatic impairment

Sponsors & Collaborators

• Baptist Health South Florida: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Related Publications (1)

• Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.

  PMID: 34658014 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Colchicine; Therapeutics; Standard of Care

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; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

The rapid decline in COVID patients and other competing trials did not allowed enrollment of additional subjects. Given the small sample size, the study was terminated.

Results Point of Contact

• Title: Raul Herrera, MD (Director Miami Cardiac & Vascular Institute)
• Organization: baptist health south florida

RaulH@BaptistHealth.net

786-596-7609

Study Officials

• Sandra Chaparro, MD

  Baptist Health South Florida

  PRINCIPAL INVESTIGATOR

• Raul E Herrera, MD

  Baptist Health South Florida

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an unblinded randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: December 23, 2020
• Primary Completion: May 12, 2021
• Study Completion: September 20, 2021
• Last Updated: July 25, 2022
• Results First Posted: March 14, 2022

Record last verified: 2022-07

Locations

US (1)