Respiratory Aerosols in Patients With COVID-19 and Healthy Controls

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04739020
• Other study ID #: 20-1001
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2021
• Source: Johann Wolfgang Goethe University Hospital
• Contact: Desiree Gutmann, MD
• Phone: 004915117190498
• Email: desiree.gutmann[@]kgu.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 525
• Est. completion date: December 31, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV-2 Infection

Intervention

Diagnostic Test:
• Resp-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.
• Spirometry
Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
• Qualitative 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).

Locations

Country	Name	City	State
Germany	Johann Wolfgang Goethe University Hospital	Frankfurt	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital	Palas GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Aerosol concentration in children and adults	Distinction between children and adults via aerosol measurement.	Each patient visit will take about 1-2 hours.
Secondary	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.
Secondary	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.
Secondary	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.