Covid19, SARS-CoV-2 Infection
Conditions
Keywords
COVID-19, Aerosol, SARS-CoV-2
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.
Interventions
DIAGNOSTIC_TESTResp-Aer-Meter
Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.
DIAGNOSTIC_TESTSpirometry
Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
DIAGNOSTIC_TESTQualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations
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).
Sponsors
Palas GmbH
Johann Wolfgang Goethe University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Contacts
Primary ContactDesiree Gutmann, MD
Backup ContactStefan Zielen, Professor
Outcome results
None listed