Clinical trial NCT04355143: Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)
Official title: Randomized, Open-Label, Controlled Trial of Colchicine to Reduce Cardiac Injury in Hospitalized COVID-19 (Coronavirus Disease 2019) Patients (COLHEART-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random assignment to study arms in a 1:1 ratio
Primary purpose: TREATMENT

Brief summary: Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm). Importantly, this adaptive trial design allows for patients in either study arm to receive other investigational drugs for COVID-19 as new science emerges.


Eligibility criteria: Inclusion Criteria:

* Confirmed COVID-19 infection by polymerase chain reaction
* 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:

* Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use 2 forms of contraception, which includes:

  * 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

Primary outcomes:
measure: Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS)
timeFrame: 90 Days
Secondary outcomes:
measure: Delta (Peak Minus Baseline) Troponin Level
timeFrame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
measure: Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level
timeFrame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
measure: Change in Left Ventricular Ejection Fraction (LVEF) on Echocardiography
timeFrame: Baseline, Day 30
measure: Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level
timeFrame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
measure: Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level
timeFrame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
measure: Composite Event-Free Survival Over Time (Days)
timeFrame: Days 0, 10, 20, 30, 40, 50, 60, 70, 80, and 90
measure: Number of Participants Requiring Mechanical Ventilation
timeFrame: 90 days
measure: Number of Participants Requiring Mechanical Circulatory Support (MCS)
timeFrame: 90 days
measure: Re-hospitalization at 90 Days
timeFrame: 90 days
measure: All-cause Mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Ronald Reagan Medical Center
state: California
city: Santa Monica
country: United States
facility: UCLA Santa Monica Hospital
state: California
city: Miami
country: United States
facility: Miami Cardiac and Vascular Institutde, Baptist Health South Florida
state: Florida
Study officials:
affiliation: University of California, Los Angeles
name: Reza Ardehali, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.