Respiratory Aerosols in Patients With COVID-19 and Healthy Controls

Study Overview
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Brief Summary
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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
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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.

Official Title
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Measurement of Respiratory Aerosols in PCR SARS-CoV-2 Positive and Negative Children and Adults

Conditions
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SARS-CoV-2 Infection, Covid19

Intervention / Treatment
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* Diagnostic Test: Resp-Aer-Meter
* Diagnostic Test: Spirometry
* Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCR SARS-CoV-2 Negative Adults<br>Healthy adults with recent negative SARS-CoV-2 PCR test (nasopharyngeal swab). Will consist of parents of participating children and other healthy volunteers. | Diagnostic Test: Resp-Aer-Meter<br>* Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.<br>Diagnostic Test: Spirometry<br>* Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.<br>Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations<br>* Comparison between result of aerosol measurement and quantitative and qualitative virus PCR of respiratory secretions that are caught in a filter in which the patient breathes for 10 minutes. Test will be conducted on patients with high aerosol concentrations (>5000/L).<br>|
| Active Comparator: PCR SARS-CoV-2 Positive Adults<br>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. | Diagnostic Test: Resp-Aer-Meter<br>* Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.<br>Diagnostic Test: Spirometry<br>* Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.<br>Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations<br>* Comparison between result of aerosol measurement and quantitative and qualitative virus PCR of respiratory secretions that are caught in a filter in which the patient breathes for 10 minutes. Test will be conducted on patients with high aerosol concentrations (>5000/L).<br>|
| Active Comparator: PCR SARS-CoV-2 Negative Children<br>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. | Diagnostic Test: Resp-Aer-Meter<br>* Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.<br>Diagnostic Test: Spirometry<br>* Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.<br>Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations<br>* Comparison between result of aerosol measurement and quantitative and qualitative virus PCR of respiratory secretions that are caught in a filter in which the patient breathes for 10 minutes. Test will be conducted on patients with high aerosol concentrations (>5000/L).<br>|
| Active Comparator: PCR SARS-CoV-2 Positive Children<br>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. | Diagnostic Test: Resp-Aer-Meter<br>* Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.<br>Diagnostic Test: Spirometry<br>* Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.<br>Diagnostic Test: Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations<br>* Comparison between result of aerosol measurement and quantitative and qualitative virus PCR of respiratory secretions that are caught in a filter in which the patient breathes for 10 minutes. Test will be conducted on patients with high aerosol concentrations (>5000/L).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerosol concentration in PCR SARS-CoV-2 positive and negative participants | Distinction between PCR SARS-CoV-2 positive and negative participants via aerosol measurement. Especially participants with high aerosol concentrations should be detected. | Each patient visit will take about 1-2 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in aerosol concentration over time in PCR SARS-CoV-2 positive participants | Characterization of longitudinal change in aerosol concentration over the course of illness in PCR SARS-CoV-2 positive patients. | 7 days | 
| Aerosol concentration in children and adults | Distinction between children and adults via aerosol measurement. | Each patient visit will take about 1-2 hours. | 
| Qualitative and quantitative virus detection in respiratory secretions of patients with high aerosol concentrations. | Quantitative and qualitative virus PCR measurements of respiratory secretions in participants with aerosol concentrations > 5000/L. | Each patient visit will take about 1-2 hours. | 
| Cofounder Analysis | Investigation of change in aerosol concentration due to confounders, such as age, sex, other viral illness, lung function, height, weight, BMI and smoking status. | Each patient visit will take about 1-2 hours. | 
| Aerosol concentration and clinical symptoms in PCR SARS-CoV-2 positive participants | 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. | Each patient visit will take about 1-2 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Aerosol, SARS-CoV-2