Quantification of Exhaled Particles to Identify Airborne Transmission Risks of COVID-19

Study Overview
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Brief Summary
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In this study, the aerosols emitted during various respiratory activities will be quantified in healthy subjects. The differences in aerosol size spectrum and number during tidal breathing, speaking, coughing and singing will be assessed. Subjects with an endogenously high aerosol emission will repeat the respiratory activities wearing face masks with varying particle filter capacity to investigate the aerosol emission reduction.

Official Title
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Quantification of Exhaled Particles to Identify Airborne Transmission Risks of SARS-Co-V-2

Conditions
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Healthy

Intervention / Treatment
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* Other: Community Mask
* Other: Surgical Mask
* Other: FFP2 respirator
* Other: FFP3 respirator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to give written informed consent. Healthy male and female subjects, aged 18-80 years. Body mass index between 18 and 35 kg/m2. FEV1 ≥ 80% predicted. Exclusion Criteria: Any clinically relevant abnormal findings in physical examination or lung function at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study. Risk of non-compliance with study procedures. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study. History of an acute respiratory infection with symptoms such as cough, rhinitis, sore throat, hoarseness or fever, within four weeks prior to the informed consent visit. In case of acute respiratory infection during study participation, the visit may be rescheduled within the allowed time window. Subjects must be asymptomatic for at least 3 days. Re-screening is allowed should the time window be exceeded. History of lung disease including but not confined to COPD, asthma or pulmonary fibrosis. History of latex allergy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: In part A of the study, aerosol emission of subjects will be characterized. From this population, the 10 highest-emitting subjects will enter part B of the study to investigate the effect of face masks on aerosol emission down to the submicron range.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Study Part A<br>Aerosol number and size spectrum characterization of 30 subjects, stratified by age groups, including 10 professional singers. Subjects will be examined twice within 14 days to assess reproducibility of aerosol emission. | |
| Experimental: Study Part B<br>From the 30 subjects of Part A, the 10 highest-emitting subjects will be assessed a third time, wearing four different classes of face masks consecutively with increasing aerosol filtering capacity. | Other: Community Mask<br>* Fabric mask, no medical device<br>Other: Surgical Mask<br>* Medical face mask (personal protective equipment), CE-certified<br>Other: FFP2 respirator<br>* Filtering Face Piece with no less than 94% filtering capacity, CE-certified<br>Other: FFP3 respirator<br>* Filtering Face Piece with no less than 99% filtering capacity, CE-certified<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the emitted small particle fraction between various respiratory activities. | Change of particle number per time unit between tidal breathing and various respiratory activities. | Day 1, Day 2 to 14 | 
| To assess the influence of different face masks on the emitted small particle fraction of various respiratory activities. | Change of particle number per time unit between tidal breathing and selected respiratory activities for community masks, surgical masks, FFP2 and FFP3 respirators in high-emitting subjects. | After completion of Study part A (approximately 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the emitted particle size distribution of various respiratory activities. | Compare changes of emitted particle size spectrum as quantity per size range during tidal breathing and selected respiratory activities. | Day 1, Day 2 to 14 | 
| To assess the reproducibility of exhaled particle quantification. | Compare results for particle number per time unit and particle size spectrum from visit 1 and 2. | Day 2 to 14 | 
| To assess the influence of different face masks on the emitted particle size distribution of various respiratory activities. | Compare changes of emitted particle size spectrum as quantity per size range during tidal breathing and selected respiratory activities for community masks, surgical masks, FFP2 and FFP3 respirators in high-emitting subjects. | After completion of Study part A (approximately 3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aerosols, Exhaled particles, Face mask