COVID-19 Outpatient Thrombosis Prevention Trial A Multi-center Adaptive Randomized Placebo-controlled Platform Trial Evaluating the Efficacy and Safety of Anti-thrombotic Strategies in COVID Adults Not Requiring Hospitalization at Time of Diagnosis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 657
- 试验地点
- 69
- 主要终点
- Hospitalization for Cardiovascular/Pulmonary Events
研究概览
简要总结
A multi-center adaptive randomized placebo-controlled platform trial evaluating the efficacy and safety of anti-thrombotic strategies in COVID-19 adults not requiring hospitalization at time of diagnosis
详细描述
The COVID-19 Outpatient Thrombosis Prevention Trial is a multi-center adaptive randomized double-blind placebo-controlled platform trial to compare the effectiveness of anti-coagulation with anti-platelet agents and with placebo to prevent thrombotic events in patients diagnosed with COVID-19 who have evidence of increased inflammation based on elevated D-dimer and hsCRP levels, yet are not admitted to hospital as COVID-19 related symptoms are currently stable. Participants will all be adults between 40 and 79 years who will be enrolled from approximately 100 facilities, such as emergency rooms and other settings where a physician is present to evaluate the patient for inclusion and exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 40 Years 至 80 Years(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
Apixaban 2.5mg
Anticoagulation: prophylactic dose Apixaban 2.5mg po bid
干预措施: Apixaban 2.5 MG (Drug)
Apixaban 5mg
Anticoagulation: therapeutic dose Apixaban 5.0mg po bid
干预措施: Apixaban 5MG (Drug)
Aspirin
Antiplatelet agent: low dose aspirin 81mg po qd
干预措施: Aspirin (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Hospitalization for Cardiovascular/Pulmonary Events
时间窗: 45 days
The primary outcome will be a composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment.
次要结局
未报告次要终点
研究者
Frank C Sciurba
Professor
University of Pittsburgh
