NCT04602871已完成不适用
Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Feasibility Study
Scentech Medical Technologies Ltd2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2020年7月3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
- 54
- 试验地点
- 2
- 主要终点
- Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection.
研究概览
简要总结
Early Detection of COVID-19 Using Breath Analysis -Feasibility Study.
详细描述
An interventional diagnostic prospective study study with risks and minimal constraints.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hospitalized group:
- •Age 18 to 75 years at the time of consent
- •Positive results for SARS-CoV-2
- •Capable of understanding written and/or spoken language
- •Able to provide informed consent
- •Was not treated with Anti-viral drugs
- •Not a pregnant woman
- •Healthy group:
- •Healthy volunteers
- •Age 18 to 75 years at the time of consent
- •No history of COVID-19
- •Capable of understanding written and/or spoken language
- •Able to provide informed consent
- •Was not treated with Anti-viral drugs
- •Not a pregnant woman
- •Sexes Eligible for Study: All
排除标准
- •Hospitalized group:
- •Age under 18 years old
- •(Anticipated) inability to complete breath sampling procedure due to e.g. hyper- or hypoventilation, respiratory failure or claustrophobia when wearing the sampling mask
- •Persons under guardianship or deprived of liberty
- •Patients with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
- •Healthy group:
- •Age under 18 years old
- •History of COVID-19
- •Persons under guardianship or deprived of liberty
- •Subjects with the following diseases: Cancer, Asthma, Chronic Respiratory Disease
结局指标
主要结局
Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection.
时间窗: Through the study completion, up to 3 months.
Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection in a swab test.
次要结局
- Correlation between Volatile Organic Compounds pattern and the course of the disease(Through the study completion, up to 3 months.)
研究者
研究点 (2)
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