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

Covid19 Clinical Trial

— Colheart-19  

Official title:

Open-label (Unblinded) Randomization to Treatment of Colchicine Plus Current Care Per Institution Treating Physicians vs. Current Care Per Institution Treating Physicians (Control Arm)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04762771
• Other study ID #: 152247
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: December 23, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: July 2022
• Source: Baptist Health South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

We aim to determine if Colchicine improves short-term outcomes in hospitalized coronavirus disease-19 (COVID-19) patients with cardiac manifestations of disease. Myocardial injury has been described in up to 30% of COVID-19 infected patients, and portends a poor prognosis with currently no known treatment. Colchicine is a widely available, well-established, inexpensive, oral anti-inflammatory agent that has been FDA approved for the treatment of inflammatory disorders including gout and familial Mediterranean Fever. Trials have also shown its benefit to prevent post-cardiotomy syndrome, to treat acute and recurrent pericarditis, and reduce cardiovascular events after myocardial infarction. We extrapolate based on these indications and studies that colchicine may also help improve outcomes in hospitalized COVID-19 patients with evidence of cardiac injury. 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)

Other known NCT identifiers

• NCT04510038

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 20, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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)

1. Elevated troponin level

2. Elevated BNP level

3. New ischemic or arrhythmogenic ECG/telemetry changes

4. New decrease in Left Ventricular Ejection Fraction (LVEF) or new pericardial effusion on echocardiogram

Exclusion Criteria:

• Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use

adequate contraception, which includes:

1. Intrauterine devices (IUD), contraceptive implants, or tubal sterilization

2. Hormone method with a barrier method

3. Two barrier methods

4. 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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Colchicine
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

Locations

Country	Name	City	State
United States	Baptist Hospital of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Baptist Health South Florida	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Composite of all-cause mortality	90 days
Primary	Mechanical Ventilation	Need for mechanical ventilation	90 days
Primary	Mechanical Circulatory Support	Need for mechanical circulatory support	90 days
Secondary	Time (Days) to the Primary End Point	Number of days from start of therapy to either mortality or need for Mechanical Ventilation or Mechanical Circulatory Support	90 days
Secondary	Peak and Delta (Change From Baseline) Troponin Level	Change from baseline to the time when Troponin levels peak during the hospitalization	baseline and 90 days
Secondary	Baseline Brain Natriuretic Peptide (BNP) Level	Documenting baseline Brain Natriuretic Peptide (BNP) at the time of hospitalization	baseline
Secondary	Inflammatory Biomarkers	Baseline and delta (change from baseline) of C-Reactive Protein	baseline and 90 days
Secondary	Hospital Length of Stay	Duration of Hospitalization on each arm	90 days
Secondary	Need for Re-hospitalization	90-day re-hospitalization rate	90 days
Secondary	Change in Inflammatory Biomarkers	Baseline and delta (change from baseline) of D-Dimer	baseline and 90 days