Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6,667
- 试验地点
- 66
- 主要终点
- Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of hospitalization, death or major thrombosis (MI, stroke, ALI, or PE)
研究概览
简要总结
ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.
详细描述
The ACT COVID-19 program consists of two parallel trials testing the effects of interventions in complementary populations in outpatients and inpatients.
In the outpatient study, symptomatic patients in the community who are COVID-19 positive and at high risk of disease progression: colchicine compared with control (anti-inflammatory); and ASA compared with control (anti-thrombotic); using a 2 x 2 factorial design. The primary outcome for colchicine vs. control is the composite of hospitalization or death. The primary outcome for ASA vs. control is the composite of hospitalization, death, or major thrombosis [myocardial infarction(MI), stroke, acute limb ischemia(ALI), or pulmonary embolism (PE)].
For inpatients, in symptomatic patients who are COVID-19 positive and who are hospitalized: colchicine is compared with control (anti-inflammatory), and the combination of ASA and rivaroxaban is compared with control (anti-thrombotic); using a 2 x 2 factorial design. The primary outcome for colchicine vs. control is the composite of high flow oxygen, mechanical ventilation, or death. The primary outcome for the combination of ASA and rivaroxaban vs. control is the composite of high flow oxygen, mechanical ventilation, death, or major thrombosis (MI, stroke, ALI, or PI).
*The Inpatient study previously also included a comparison of Interferon-β with control in a 2x2x2 design. The Interferon-β arm was closed to recruitment in November 2020.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Colchicine
Outpatients:
0.6 mg twice daily for 3 days, then 0.6 mg once daily for 25 days (total 28 days).
Inpatients:
1.2 mg followed by 0.6 mg 2 hours later, then 0.6 mg twice daily for 28 days.
(*Depending on availability, 0.6 mg tablets can be substituted by 0.5 mg tablets for a regimen in outpatients of 0.5 mg twice daily for 3 days, then 0.5 mg once daily for 25 days [total 28 days]; and in inpatients of 1.0 mg followed by 0.5 mg 2 hours later, then 0.5 mg twice daily for 28 days).
干预措施: Colchicine (Drug)
Interferon Beta [This arm is now closed to recruitment]
Inpatients Only:
0.25 mg by subcutaneous injection on days 1, 3, 5 & 7
干预措施: Interferon-Beta (Drug)
Aspirin (ASA)
Outpatients:
75 to 100 mg once daily for 28 days.
Inpatients:
75 to 100 mg once daily for 28 days
干预措施: Aspirin (Drug)
Rivaroxaban
Inpatients Only:
2.5 mg twice daily for 28 days.
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of hospitalization, death or major thrombosis (MI, stroke, ALI, or PE)
时间窗: 45 days post randomization
Outpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of hospitalization or death
时间窗: 45 days post randomization
Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or death
时间窗: 45 days post randomization
Inpatient trial - Aspirin and Rivaroxaban vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, death or major thrombosis (MI, stroke, ALI, or PE)
时间窗: 45 days post randomization
次要结局
- Outpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)(45 days post randomization)
- Inpatient trial - Colchicine vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death(45 days post randomization)
- Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of the composite of high flow oxygen, mechanical ventilation, or respiratory death(45 days post randomization)
- Inpatient trial - Aspirin vs. control: Time from randomization to first occurrence of any thrombosis (MI, stroke, ALI, PE, or DVT)(45 days post randomization)