Respiratory Aerosols in Patients With COVID-19 and Healthy Controls
- Conditions
- SARS-CoV-2 InfectionCovid19
- Interventions
- Diagnostic Test: Resp-Aer-MeterDiagnostic Test: SpirometryDiagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations
- Registration Number
- NCT04739020
- Lead Sponsor
- Johann Wolfgang Goethe University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 525
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCR SARS-CoV-2 Negative Children Resp-Aer-Meter Children with recent negative SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of children admitted to the Children's Hospital or presenting for planned diagnostic testing or follow up. PCR SARS-CoV-2 Positive Children Resp-Aer-Meter Children with recent positive SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of asymptomatic children that are admitted to the Children's Hospital for reasons other than COVID-19 and symptomatic children. PCR SARS-CoV-2 Negative Adults Resp-Aer-Meter Healthy adults with recent negative SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of parents of participating children and other healthy volunteers. PCR SARS-CoV-2 Negative Adults Spirometry Healthy adults with recent negative SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of parents of participating children and other healthy volunteers. PCR SARS-CoV-2 Negative Adults Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations Healthy adults with recent negative SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of parents of participating children and other healthy volunteers. PCR SARS-CoV-2 Positive Adults Resp-Aer-Meter Adults with recent positive SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of asymptomatic parents that are in the hospital with their children and symptomatic adults that are admitted to the infectious disease ward. PCR SARS-CoV-2 Positive Adults Spirometry Adults with recent positive SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of asymptomatic parents that are in the hospital with their children and symptomatic adults that are admitted to the infectious disease ward. PCR SARS-CoV-2 Negative Children Spirometry Children with recent negative SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of children admitted to the Children's Hospital or presenting for planned diagnostic testing or follow up. PCR SARS-CoV-2 Positive Children Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations Children with recent positive SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of asymptomatic children that are admitted to the Children's Hospital for reasons other than COVID-19 and symptomatic children. PCR SARS-CoV-2 Positive Adults Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations Adults with recent positive SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of asymptomatic parents that are in the hospital with their children and symptomatic adults that are admitted to the infectious disease ward. PCR SARS-CoV-2 Negative Children Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations Children with recent negative SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of children admitted to the Children's Hospital or presenting for planned diagnostic testing or follow up. PCR SARS-CoV-2 Positive Children Spirometry Children with recent positive SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of asymptomatic children that are admitted to the Children's Hospital for reasons other than COVID-19 and symptomatic children.
- Primary Outcome Measures
Name Time Method Aerosol concentration in PCR SARS-CoV-2 positive and negative participants 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.
- Secondary Outcome Measures
Name Time Method Change in aerosol concentration over time in PCR SARS-CoV-2 positive participants 7 days Characterization of longitudinal change in aerosol concentration over the course of illness in PCR SARS-CoV-2 positive patients.
Aerosol concentration in children and adults Each patient visit will take about 1-2 hours. Distinction between children and adults via aerosol measurement.
Qualitative and quantitative virus detection in respiratory secretions of patients with high aerosol concentrations. Each patient visit will take about 1-2 hours. Quantitative and qualitative virus PCR measurements of respiratory secretions in participants with aerosol concentrations \> 5000/L.
Cofounder Analysis Each patient visit will take about 1-2 hours. Investigation of change in aerosol concentration due to confounders, such as age, sex, other viral illness, lung function, height, weight, BMI and smoking status.
Aerosol concentration and clinical symptoms in PCR SARS-CoV-2 positive participants Each patient visit will take about 1-2 hours. Correlation between clinical symptoms and results of aerosol measurement in PCR SARS-CoV-2 positive participants. Determination if more symptoms lead to higher aerosol concentrations.
Trial Locations
- Locations (1)
Johann Wolfgang Goethe University Hospital
🇩🇪Frankfurt, Hessen, Germany