NCT04899232终止2 期
Antithrombin III (AT3) in Infectious Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)/ Coronavirus Disease of 2019 (COVID-19)
Enrique Ginzburg1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年7月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in ISTH DIC Score
研究概览
简要总结
The purpose of this research study is to see if participants who have SARS-CoV-2 and low levels of AT3 in the blood will benefit by being given AT3.
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
AT3 less than 100% with SOC plus AT3 supplement
Experimental
Participants in this group, with endogenous Antithrombin lll less than 100%, will receive 5 doses of supplemental Antithrombin III on Days 1, 3, 5, 7 and 9, in addition to standard of care (SOC) treatment.
干预措施: Antithrombin III (Drug)
结局指标
主要结局
Change in ISTH DIC Score
时间窗: Baseline, Day 9
As measured by the International Society of Thrombosis and Haemostasis Disseminated Intravascular Coagulation scale (ISTH DIC) which has a total score ranging from 0-8 with a score of 5 and higher indicating overt DIC.
次要结局
- Change in Fibrinogen Levels(Baseline, Day 9)
- Mortality Rate(Up to 60 days)
- Pulmonary Function(Up to 60 days)
- Change in SOFA Respiratory Sub Score(Baseline, Day 9)
- Change in SOFA Scores(Baseline, Day9)
- Number of Events of Venous Thromboembolism(Up to 60 days)
- Length of Hospital Stay(Up to 60 days)
- Number of Events of Major Bleeding(Up to 60 days)
- Change in D-Dimer Levels(Baseline, Day 9)
- Change in Prothrombin Time(Baseline, Day 9)
研究者
Enrique Ginzburg
Professor
University of Miami
研究点 (1)
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