Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Frequency of activated protein C resistance and comparison between groups
研究概览
简要总结
Context: Until 70% of thrombotic event are reported during Sars-CoV2 infection. Antiphospholipid antibodies (aPL) tests are often positive. We aim to determine if aPL positivity is involved in thrombose of Sars-CoV2 infection investigating the effect of aPL on thrombin generation (TG) and leucocyte pathway activation (neutrophils extracellular traps (NETs) and activation of triggering receptor expressed on myeloid cells 1 (TREM-1)).
Method: We will compare plasma from five groups of subjects: patients with antiphospholipid syndrome (APS) and patients hospitalized for Sars-CoV-2 infection with or without aPL, and as control, patients with acute venous thromboembolism event and healthy volunteers. For each subject, we will analyze aPL, activated protein C (APC) resistance measured by TG and leukocytes markers as circulating neutrophils extracellular traps (NETs) and soluble triggering receptor expressed on myeloid cells one (sTREM-1). We will control aPL test at three month and analyze their persistent positivity and association with thrombotic event.
Results: we hypothesize that patients with COVID-19 and aPL will have a similar aPL and level of APS resistance that patients with APS. Also, we think that circulating NETs and sTREM-1 levels will be more important in patients with COVID-19 with aPL than patients without aPL and similar in patients with COVID-19 and aPL and patients with APS.
Conclusion: our study will be the first to analyze the potential role of aPL on APC resistance measured by TG and neutrophil activation in COVID-19.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient receiving a comprehensive information about the study, and not opposed to participate
- •+ one criterion among :
- •patient hospitalized fo a COVID-19
- •Patient with known APS
- •Patients hospitalized for an acute venous thromboembolism event aPL positivity or COVID-19
- •healthy volunteers
排除标准
- •For all participants : pregnancy, age below 18 years-old, absence of written informed consent , autoimmune or inflammatory disease except antiphospholipid syndrome
- •For patients with COVID-19: previous aPL positivity (before COVID-19 infection)
- •For patients with APS: previous symptomatic COVID-19 infection
- •For patients control with acute venous thromboembolism event: previous symptomatic COVID-19 infection, infection or inflammatory disease in flare at the time of thromboembolism event, known aPL positivity
- •For Healthy volunteers: history of thrombosis (venous, arterial or small vessels), previous symptomatic COVID-19 infection, infection or inflammatory disease in flare at the time of inclusion, known aPL positivity
结局指标
主要结局
Frequency of activated protein C resistance and comparison between groups
时间窗: at inclusion
次要结局
- frequency of positivity of each aPL test and comparison between groups(at inclusion)
- concentration of leucocytes activation markers and comparison between groups(at inclusion)
- frequency of persistent aPL test positivity and comparison between groups(at three month)
研究者
Virginie Dufrost
Dr
Central Hospital, Nancy, France