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临床试验/NCT04498273
NCT04498273终止3 期

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

Frank C Sciurba69 个研究点 分布在 1 个国家目标入组 657 人开始时间: 2020年9月7日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Apixaban 2.5mg

Active Comparator

Anticoagulation: prophylactic dose Apixaban 2.5mg po bid

干预措施: Apixaban 2.5 MG (Drug)

Apixaban 5mg

Active Comparator

Anticoagulation: therapeutic dose Apixaban 5.0mg po bid

干预措施: Apixaban 5MG (Drug)

Aspirin

Active Comparator

Antiplatelet agent: low dose aspirin 81mg po qd

干预措施: Aspirin (Drug)

Placebo

Placebo Comparator

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

发起方
Frank C Sciurba
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Frank C Sciurba

Professor

University of Pittsburgh

研究点 (69)

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