Colchicine vs Current Standard of Care in Hospitalized Patients With COVID-19 and Cardiac Injury

Covid19 Clinical Trial

— COLHEART-19  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04510038
• Other study ID #: 152247
• Status: Suspended
• Phase: Phase 2/Phase 3
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Miami Cardiac and Vascular Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Open-label randomized study comparing the current standard of care treatment of Covid-19 in hospitalized patients with evidence of cardiac injury vs. a group of the same type of patients treated with colchicine plus current standard of care.

Description:

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 and randomized study comparing the treatment of colchicine plus current care (per institution treating physicians) as the active arm vs. current standard of care alone (per institution treating physicians) as the control arm.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 75
• Est. completion date: December 31, 2022
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Men and Women = 18 years of age

2. Cardiac injury (any of the following)

1. Elevated troponin level

2. Elevated BNP level

3. New ischemic or arrhythmogenic ECG/telemetry changes

4. New decrease in LVEF or new pericardial effusion on echocardiogram

3. Able to provide informed consent

Exclusion Criteria:

1. 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

2. History of severe hematologic or neuromuscular disorder

3. Co-administration of CYPA3A4 and P-glycoprotein transport inhibitor

4. Severe renal impairment with concomitant hepatic impairment

5. Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or hepatic impairment

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Myocardial Injury
• Wounds and Injuries

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 CKD stage = 4 (CrCl = 30 ml/min) or liver failure (AST/ALT > 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

Other:
• Covid-19 Standard of Care
As per treating physician

Locations

Country	Name	City	State
United States	Baptist Health South Florida	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Miami Cardiac and Vascular Institute	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Cause 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 to Deterioration	Time to Primary Endpoint	90 days
Secondary	Adverse Events	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".	90 days
Secondary	Troponin	Peak Troponin Levels	90 days
Secondary	Delta	Troponin Levels Change from Baseline	90 days
Secondary	BNP	Change from Baseline on BNP levels	90 days
Secondary	Changes in C Reactive Protein	Changes from Baseline on C Reactive Protein	90 days
Secondary	LOS	Hospital Length of Stay	90 days
Secondary	Re-Hospitalization	Re-Hospitalization Rates	90 days
Secondary	Changes in D Dimer	Changes in D Dimer from Baseline	90 days