A Single Center, Two Arms, Non-interventional, Breath Samples Collection Clinical Trial, for Development of the TERA Bio Station T101, Intended for SARS-CoV-2 Exhalation Products Detection.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
The Sponsor has developed a rapid screening tool intended to determine if the subject tested has COVID-19.
详细描述
According to recent scientific literature, the virus infection occurs mainly through the nasal cavity, and therefore, samples of nasal and pharyngeal fluids are expected to be high viral load samples.
The proposed clinical trial is to test the mentioned for potential dominant virus particles absorbance frequencies according to which, it will be possible to perform a statistical analysis of spectral data of infected subjects' samples compared to healthy ones and to examine whether a statistical significance between 'Infected' and 'Healthy' can be demonstrated in terms spectroscopic measurements.
Indication for Use: Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.
The study is aimed to collect data in order to assess whether a patient's COVID -19 status can be identified by a unique spectrophotometric pattern.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subject aged 18 years and above
- •Subject is able and willing to provide informed consent
- •Subject is able to complete the breath test.
- •Requiring a diagnostic or screening RT-PCR test for COVID-
- •Positive to COVID-19 in RT-PCR test performed up to 48 hours before screening.
排除标准
- •Male of female subject under the age of
- •Subject is unable to provide and informed consent, for any reason.
结局指标
主要结局
Primary Outcome Measure
时间窗: The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample
Rate of positive and negative cases in collected breath samples using breath analyzer test compare to PCR results.
次要结局
未报告次要终点