NCT04602884已完成不适用
Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis: First Cross-Sectional Study
Scentech Medical Technologies Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年9月22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
- 50
- 试验地点
- 1
- 主要终点
- Correlation between Volatile Organic Compounds pattern and COVID-19 detection status.
研究概览
简要总结
EARLY DETECTION OF COVID-19 USING BREATH ANALYSIS- FIRST CROSS-SECTIONAL STUDY
详细描述
Primary objective- to identify and evaluate a set of biomarkers that represent both the genetic expression of the virus itself (SARS-CoV-2) and the metabolic activity of the immune system's response to the virus.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 55 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
排除标准
- •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
- •Pregnant women
- •Treated with antiviral drugs upon admission or during hospitalization
- •Novices and soldiers in initial training
结局指标
主要结局
Correlation between Volatile Organic Compounds pattern and COVID-19 detection status.
时间窗: Through the study completion, up to 3 months.
Correlation between the set of Volatile Organic Compounds found in breath biopsy and COVID-19 detection presence in a swab test.
次要结局
- Correlation between Volatile Organic Compounds pattern and time from COVID-19 detection.(Through the study completion, up to 3 months.)
- Correlation between the set of Volatile Organic Compounds found in breath biopsy and disease intensity.(Through the study completion, up to 3 months.)
研究者
研究点 (1)
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