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

NCT ID: NCT04762771

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-23
• Study Completion Date: 2021-09-20

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)

Detailed 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)

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active

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

Group Type: ACTIVE_COMPARATOR

Colchicine

Intervention Type: 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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Treatment with Colchicine plus standard of care in hospitalized patients with Covid-19

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Baptist Health South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Chaparro, MD

Role: PRINCIPAL_INVESTIGATOR

Baptist Health South Florida

Raul E Herrera, MD

Role: STUDY_DIRECTOR

Baptist Health South Florida

Locations

Baptist Hospital of Miami

Miami, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34658014 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

152247

Identifier Type: -

Identifier Source: org_study_id

NCT04510038

Identifier Type: -

Identifier Source: nct_alias