NCT04367545已完成不适用
Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic
University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年4月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Number of positive patient using saliva method compared to number of positive patient using standard method
研究概览
简要总结
The objective of the study is to develop and validate a molecular diagnostic strategy (RT-ddPCR multiplex) of COVID-19 based on a saliva sample and alternative to the RT-qPCR method, in order to :
- to compensate for the risk of a shortage of diagnostic kits, reagents and materials necessary for molecular diagnosis;
- to increase the molecular diagnostic capacity of COVID-19 at the Rouen University Hospital;
- and to have a method compatible with screening extended to populations at risk.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Person aged over 18 years presenting to the COVID-19 consultation of the Rouen University Hospital for screening
- •Person affiliated to a social security scheme
排除标准
- •Person objecting to participation in the research after reading information
- •Person under the protection of justice,
- •Person deprived of their liberty by administrative or judicial decision (guardianship, curatorship, etc.)
- •Patient under guardianship or curatorship
研究组 & 干预措施
Patient with COVID-19 infection suspicion
Experimental
Patient with COVID-19 infection suspicion are tested using standard diagnosis method
干预措施: Saliva collection (Diagnostic Test)
结局指标
主要结局
Number of positive patient using saliva method compared to number of positive patient using standard method
时间窗: One hour
Number of negative patient using saliva method compared to number of negative patient using standard method
时间窗: One hour
次要结局
未报告次要终点
研究者
研究点 (1)
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