Respiratory Aerosols in Patients With COVID-19 and Healthy Controls

Not Applicable

• Conditions: SARS-CoV-2 Infection; Covid19

• 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.

Study Timeline

• Study Start: 2021-01-18
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-14
• Last Update Posted: 2021-12-15
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 525

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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