Impact of Previous Treatment With Angiotensin II Receptor Blockers in Patients With SARS-Cov2 Infection Admitted to the Intensive Care Unit on Survival and Severity of the Disease (COVID-ARA2)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ACE2 level change over time
研究概览
简要总结
The actual pandemic infection related to SARS-CoV2 results in viral pneumonitis (COVID-19), that may, in the more severe cases, lead the patients to the intensive care unit (ICU). The more frequent presentation is acute respiratory distress syndrome (ARDS).
To penetrate cells, SARS-CoV2 uses Angioconvertase type 2 (ACE2) as a cellular entry receptor.
ACE2 belong to the renin-angiotensin-aldosteron system (SRAA), and ACE2 levels are directly modified when SRAA inhibitors are administred to patients, and ACE2 level increases particularely with Angiotensin II Receptor blockers (ARA2) use.
The aim of our study is to determine ACE2 level and activity in patients with SARSCoV2 infection admitted to the intensive care unit (ICU).
COVID ARA2 is a propsective cohort of patient with blood sampling at the day of admission, day 3 and day 7.
详细描述
The actual pandemic infection related to SARS-CoV2 results in viral pneumonitis (COVID-19), that may, in the more severe cases, lead the patients to the intensive care unit (ICU). The more frequent presentation is acute respiratory distress syndrome (ARDS).
To penetrate cells, SARS-CoV2 uses Angioconvertase type 2 (ACE2) as a cellular entry receptor.
ACE2 belong to the renin-angiotensin-aldosteron system (SRAA), and ACE2 levels are directly modified when SRAA inhibitors are administred to patients, and ACE2 level increases particularely with Angiotensin II Receptor Blockers (ARA2) use.
The aim of our study is to determine ACE2 level and activity in patients with SARSCoV2 infection admitted to the intensive care unit (ICU).
COVID ARA2 is a propsective cohort of patient with blood sampling at the day of admission, day 3 and day 7.
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
- 否
入选标准
- •admission to the intensive care unit,
- •with a proven COVID infection, responsible for acute respiratory failure
- •agree with participation to the study.
排除标准
- •aged under 18
- •under legal protection
- •pregnant or breastfeeding
结局指标
主要结局
ACE2 level change over time
时间窗: at the day of admission, day 3 and day 7
ELISA test (Higher the ACE2 level, higher the virus penetrate cells)
次要结局
- ACE2 activity over time(at the day of admission, day 3 and day 7)
- Mortality at day 28(day 28)
- ARDS severity(from the day of admission to day 7)
- Duration of mechanical ventilation(from the day of admission to day 28)
- Need for extracorporeal membran oxygenation(from the day of admission to day 28)
- Use of paralytic agents(from the day of admission to day 28)
- Number of session(s) of prone positionning(from the day of admission to day 28)
- Duration of extracorporeal membran oxygenation treatment(from the day of admission to day 28)
- Need for prone positionning(from the day of admission to day 28)
- Need for renal replacement therapy(from the day of admission to day 28)
- Need for vasoactive drugs (norepinephrine, dobutamine,epinephrine)(from the day of admission to day 28)
- Duration of vasoactive treatment(from the day of admission to day 28)
- Sequential Organ Failure Assessment (SOFA) score(from the day of admission to day 7)
- Type of vasoactive drugs(from the day of admission to day 28)