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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine plus current care | Experimental | Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians |
|
| Current care alone | Active Comparator | Current care per UCLA physicians alone (control arm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine Tablets | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS) | Number of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS) | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Delta (Peak Minus Baseline) Troponin Level | Change from initial troponin level to maximum level of troponin among measures taken during hospitalization and at 30 days | Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized |
| Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level |
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Inclusion Criteria:
Confirmed COVID-19 infection by polymerase chain reaction
Cardiac injury, including any of the following:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Reza Ardehali, MD, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Ronald Reagan Medical Center | Los Angeles | California | 90095 | United States | ||
| UCLA Santa Monica Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35783822 | Derived | 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. | |
| 34473343 |
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Of 304 screened individuals that met inclusion criteria,169 met exclusion criteria, 11 had co-enrollment conflicts with other clinical trials, 31 declined to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Colchicine Plus Current Care | Colchicine 0.6 mg po BID (twice a day) 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 |
| FG001 | Current Care Alone | Current care per UCLA physicians alone (control arm) Current care per UCLA treating physicians: Current care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS) | Number of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS) | Posted | Count of Participants | Participants | 90 Days |
|
90 Days
Due to illness of study participants, Adverse Events were recorded as such only if thought to be at least possibly related to study intervention, and not likely due to the primary disease process or its treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reza Ardehali, MD, PhD | University of California Los Angeles | 310-825-5280 | rardehali@mednet.ucla.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 5, 2020 | Aug 23, 2022 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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Random assignment to study arms in a 1:1 ratio
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|
| Current care per UCLA treating physicians | Other | Current care |
|
Change from baseline BNP level (Day 1) to maximum level of BNP among measures taken during hospitalization and at 30 days |
| Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized |
| Change in Left Ventricular Ejection Fraction (LVEF) on Echocardiography | Number of participants experiencing LVEF of < 50% on echocardiogram with failure to show an improvement of ≥ 5% at 30 days | Baseline, Day 30 |
| Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level | Change from baseline CRP level (Day 1) to maximum level of CRP among measures taken during hospitalization and at 30 days | Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized |
| Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level | Change from baseline D-Dimer level (Day 1) to maximum level among measures taken during hospitalization and at 30 days. D-Dimer is a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis, so named because it contains two D fragments of the fibrin protein joined by a cross-link. | Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized |
| Composite Event-Free Survival Over Time (Days) | Participants reaching primary (composite) endpoint were subtracted from event-free survival reported at 10-day intervals | Days 0, 10, 20, 30, 40, 50, 60, 70, 80, and 90 |
| Number of Participants Requiring Mechanical Ventilation | 90 days |
| Number of Participants Requiring Mechanical Circulatory Support (MCS) | 90 days |
| Re-hospitalization at 90 Days | Number of participants released and re-admitted to the hospital within 90 days of enrollment | 90 days |
| All-cause Mortality | 90 days |
| Santa Monica |
| California |
| 90404 |
| United States |
| Miami Cardiac and Vascular Institutde, Baptist Health South Florida | Miami | Florida | 33176 | United States |
| 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. |
| BG001 |
| Current Care Alone |
Current care per UCLA physicians alone (control arm) Current care per UCLA treating physicians: Current care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Clinical Risk Factors | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight (kg) divided by height (m) squared. | Participants for whom BMI measurements were recorded at baseline. | Mean | Standard Deviation | kg/m^2 |
|
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
|
| Secondary | Delta (Peak Minus Baseline) Troponin Level | Change from initial troponin level to maximum level of troponin among measures taken during hospitalization and at 30 days | Posted | Mean | Standard Deviation | ng/mL | Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized |
|
|
|
| Secondary | Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level | Change from baseline BNP level (Day 1) to maximum level of BNP among measures taken during hospitalization and at 30 days | Participants with analyzable samples at each timepoint | Posted | Mean | Standard Deviation | pg/mL | Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized |
|
|
|
| Secondary | Change in Left Ventricular Ejection Fraction (LVEF) on Echocardiography | Number of participants experiencing LVEF of < 50% on echocardiogram with failure to show an improvement of ≥ 5% at 30 days | no participant was able to receive a repeat echocardiogram at day 30 | Posted | Baseline, Day 30 |
|
|
| Secondary | Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level | Change from baseline CRP level (Day 1) to maximum level of CRP among measures taken during hospitalization and at 30 days | Participants with analyzable samples at each timepoint | Posted | Mean | Standard Deviation | mg/dL | Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized |
|
|
|
| Secondary | Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level | Change from baseline D-Dimer level (Day 1) to maximum level among measures taken during hospitalization and at 30 days. D-Dimer is a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis, so named because it contains two D fragments of the fibrin protein joined by a cross-link. | Participants with analyzable samples at each timepoint | Posted | Mean | Standard Deviation | µg/mL | Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized |
|
|
|
| Secondary | Composite Event-Free Survival Over Time (Days) | Participants reaching primary (composite) endpoint were subtracted from event-free survival reported at 10-day intervals | in the rare event of missing data, patients were excluded from analyses | Posted | Count of Participants | Participants | Days 0, 10, 20, 30, 40, 50, 60, 70, 80, and 90 |
|
|
|
| Secondary | Number of Participants Requiring Mechanical Ventilation | Posted | Count of Participants | Participants | 90 days |
|
|
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| Secondary | Number of Participants Requiring Mechanical Circulatory Support (MCS) | Posted | Count of Participants | Participants | 90 days |
|
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| Secondary | Re-hospitalization at 90 Days | Number of participants released and re-admitted to the hospital within 90 days of enrollment | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | All-cause Mortality | in the rare event of missing data, patients were excluded from analyses | Posted | Count of Participants | Participants | 90 days |
|
|
|
| 8 |
| 48 |
| 0 |
| 48 |
| 2 |
| 48 |
| EG001 | Current Care Alone | Current care per UCLA physicians alone (control arm) Current care per UCLA treating physicians: Current care | 6 | 45 | 0 | 45 | 0 | 45 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Day 90 |
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