Randomized, Open-Label, Controlled Trial of Colchicine to Reduce Cardiac Injury in Hospitalized COVID-19 (Coronavirus Disease 2019) Patients (COLHEART-19)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 3
- 主要终点
- Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Colchicine plus current care
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
干预措施: Colchicine Tablets (Drug)
Colchicine plus current care
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
干预措施: Current care per UCLA treating physicians (Other)
Current care alone
Current care per UCLA physicians alone (control arm)
干预措施: Current care per UCLA treating physicians (Other)
结局指标
主要结局
Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS)
时间窗: 90 Days
Number of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)
次要结局
- Delta (Peak Minus Baseline) Troponin Level(Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized)
- Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level(Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized)
- Change in Left Ventricular Ejection Fraction (LVEF) on Echocardiography(Baseline, Day 30)
- Re-hospitalization at 90 Days(90 days)
- All-cause Mortality(90 days)
- Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level(Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized)
- Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level(Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized)
- Composite Event-Free Survival Over Time (Days)(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)