NCT04602949已完成不适用
Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Validation Study
Scentech Medical Technologies Ltd1 个研究点 分布在 1 个国家目标入组 2,558 人开始时间: 2020年11月12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
- 2,558
- 试验地点
- 1
- 主要终点
- Presence of Volatile Organic Compounds indicating carriers of COVID-19.
研究概览
简要总结
DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY
详细描述
A diagnostic prospective single-site study, with no anticipated risks or constraints.
Primary objective- To validate the value of a set of breath VOC biomarkers that enable us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6 to 75 years at the time of consent
- •Capable of understanding written and/or spoken language
- •Able to provide informed consent
- •Was not treated with Anti-viral drugs
排除标准
- •Age under 6 years old
- •Under guardianship or deprived of liberty
- •Pregnant or lactating woman
结局指标
主要结局
Presence of Volatile Organic Compounds indicating carriers of COVID-19.
时间窗: Through the study completion, up to 3 months.
Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls.
次要结局
- sensitivity level of biomarkers' algorithm.(Through the study completion, up to 3 months.)
- Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.).(Through the study completion, up to 3 months.)
研究者
研究点 (1)
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