NCT04367142已完成不适用
Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept
University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年8月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of the COR-DIAL based on nasopharyngeal swabs taken on admission of the patient compared to the final diagnosis of COVID-19 made by the medical team
研究概览
简要总结
The objective of study is to estimate the sensitivity and specificity of the COR-DIAL based on nasopharyngeal samples taken at the patient's admission in relation to the final diagnosis of COVID-19 made by the medical team.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female or child without age limit
- •Admitted to a Reference Health Establishment in an emergency unit, hospitalisation or intensive care unit for suspicion of SARS-CoV-2 infection, regardless of the clinical presentation and degree of severity.
- •Patient to be diagnosed using a PCR test on nasopharyngeal swab.
- •Social insured
排除标准
- •Atypical or suspicious cases without a final diagnosis of COVID-19 positive or negative
- •Patient refusal to participate
结局指标
主要结局
Sensitivity and specificity of the COR-DIAL based on nasopharyngeal swabs taken on admission of the patient compared to the final diagnosis of COVID-19 made by the medical team
时间窗: Baseline (at admission)
次要结局
- Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and COR-DIAL based on nasopharyngeal swabs taken on patient admission(Baseline (at admission))
研究者
研究点 (1)
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