Exploration of Feasability of Blood and Saliva Proteomic Analysis Through Harvesting by Silica Matrix
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Feasibility of proteomic profile
研究概览
简要总结
Phase 1:
25 patients with a PCR-based diagnosis of Covid-19 will be be included to give 500 microliters of saliva and a 3 ml sample of blood for proteomic analysis; a drop of blood will also be put in a device connected to a silica matrix to perform spectrometric analyses. 25 patients with a non-Covid-19 respiratory infection will be included for the same samples. The proteomic analyses will be performed from classicaly draught blood, blood drop on silica, and saliva, to search for discriminating profiles between Covid-19 and non-Covid-19.
Phase 2:
150 patients with a suspected Covid-19 will be included at the same time than the Covid-19PCR is performed ; they will have a sample of saliva and of a drop of blood for proteomic analysis, whose results will be matched with PCR results.
详细描述
Phase 1: derivation analyses 25 patients with a PCR-based diagnosis of Covid-19 will be be included to give 500 microliters of saliva and a 3 ml sample of blood for proteomic analysis; a drop of blood will also be put in a device connected to a silica matrix to perform spectrometric analyses. 25 patients with a non-Covid-19 respiratory infection will be included for the same samples. The proteomic analyses will be performed from classicaly draught blood, blood drop on silica, and saliva, to search for discriminating profiles between Covid-19 and non-Covid-19.
Phase 2: confirmation analyses 150 patients with a suspected Covid-19 will be included at the same time than the Covid-19PCR is performed ; they will have a sample of saliva and of a drop of blood for proteomic analysis, whose results will be matched with PCR results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for group 1:
- •positive Covid-19 PCR
- •clinical signs evocative of Covid-19
排除标准
- •for group 1:
- •asymptomatic Covid-19 infection
- •Inclusion Criteria for group 1:
- •negative Covid-19 PCR
- •acute respiratory infection
- •Exclusion Criteria for group 1:
- •Inclusion Criteria:
- •suspicion of Covid-19
- •sample for Covid-19 PCR planned or performed the same day
- •admission ot emergency room exclusion criteria:
- •past known Covid-19
结局指标
主要结局
Feasibility of proteomic profile
时间窗: one day
MALDI-TOF mass spectrometric analysis of blood and saliva proteins to obtain a specific proteomic profile (obtained or not)
次要结局
- Stability of proteomic profile(two days)
- Interest of proteomic profile(one day)