Measurement of Respiratory Aerosols in PCR SARS-CoV-2 Positive and Negative Children and Adults
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 525
- 试验地点
- 2
- 主要终点
- Aerosol concentration in PCR SARS-CoV-2 positive and negative participants
研究概览
简要总结
The proposed study will investigate respiratory aerosols in SARS-CoV-2 (Severe Acute Respiratory Syndrome Corona Virus 2) positive and negative children and adults with the Resp-Aer-Meter (Palas GmbH). For this purpose, first, the measurement of respiratory aerosols (particle sizes and concentration) with the Resp-Aer-Meter will be established. Thereafter, a comparison between polymerase chain reaction (PCR) SARS-CoV-2 positive and negative participants (children and adults) will be conducted. In addition to the measurement of aerosols, the clinical symptoms, lung function (FEV1) and laboratory inflammatory markers will be analyzed.
详细描述
Corona virus disease 2019 (COVID-19) is a viral illness caused by SARS-CoV-2. Current research suggests that the SARS-CoV-2 infection is primarily spread through droplets and aerosols. As per current literature, the spread through asymptomatic carriers, as well as highly contagious carriers ('super spreader') play an important role in the infectiousness of the virus. It is currently unclear, if the contagiousness of children differs from adults.
In the proposed investigation, measurement of the particle size and concentration in respiratory aerosols will be conducted via the Resp-Aer-Meter (Palas GmbH). First step will be to establish the measurements with this new device. Thereafter, a comparison between PCR SARS-CoV-2 positive and negative participants, as well as between children and adults, will be conducted. In addition to the measurement of aerosols, the clinical symptoms suggestive of COVID-19, lung function (FEV1) and laboratory inflammatory markers, if available, will be analyzed.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6 years or older
- •SARS-CoV-2 PCR testing within the last 3 days
- •Ability to capture extend and consequences of the study
- •Written informed consent of patient and, if applicable, of caregiver
排除标准
- •Age under 6 years
- •Inability to participate in aerosol measurement
- •Inability to participate in Spirometry
- •Inability to capture extend and consequences of the study
- •Only for arm 1 (PCR SARS-CoV-2 negative adults): chronic disease with immunosuppressive therapy
结局指标
主要结局
Aerosol concentration in PCR SARS-CoV-2 positive and negative participants
时间窗: Each patient visit will take about 1-2 hours.
Distinction between PCR SARS-CoV-2 positive and negative participants via aerosol measurement. Especially participants with high aerosol concentrations should be detected.
次要结局
- Change in aerosol concentration over time in PCR SARS-CoV-2 positive participants(7 days)
- Aerosol concentration in children and adults(Each patient visit will take about 1-2 hours.)
- Qualitative and quantitative virus detection in respiratory secretions of patients with high aerosol concentrations.(Each patient visit will take about 1-2 hours.)
- Cofounder Analysis(Each patient visit will take about 1-2 hours.)
- Aerosol concentration and clinical symptoms in PCR SARS-CoV-2 positive participants(Each patient visit will take about 1-2 hours.)
研究者
Stefan Zielen
Professor Stefan Zielen
Johann Wolfgang Goethe University Hospital