Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)
NCT ID: NCT04355143
Last Updated: 2022-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2020-05-01
2021-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Colchicine plus current care
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine Tablets
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.
Current care per UCLA treating physicians
Current care
Current care alone
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians
Current care
Interventions
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Colchicine Tablets
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.
Current care per UCLA treating physicians
Current care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
Responsible Party
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Principal Investigators
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Reza Ardehali, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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UCLA Ronald Reagan Medical Center
Los Angeles, California, United States
UCLA Santa Monica Hospital
Santa Monica, California, United States
Miami Cardiac and Vascular Institutde, Baptist Health South Florida
Miami, Florida, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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20-000685
Identifier Type: -
Identifier Source: org_study_id
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