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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-29

Study Completion Date

2021-08-20

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Study Part A

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Study Part B

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.

Group Type EXPERIMENTAL

Community Mask

Intervention Type OTHER

Fabric mask, no medical device

Surgical Mask

Intervention Type OTHER

Medical face mask (personal protective equipment), CE-certified

FFP2 respirator

Intervention Type OTHER

Filtering Face Piece with no less than 94% filtering capacity, CE-certified

FFP3 respirator

Intervention Type OTHER

Filtering Face Piece with no less than 99% filtering capacity, CE-certified

Interventions

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Community Mask

Fabric mask, no medical device

Intervention Type OTHER

Surgical Mask

Medical face mask (personal protective equipment), CE-certified

Intervention Type OTHER

FFP2 respirator

Filtering Face Piece with no less than 94% filtering capacity, CE-certified

Intervention Type OTHER

FFP3 respirator

Filtering Face Piece with no less than 99% filtering capacity, CE-certified

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Able and willing to give written informed consent.
2. Healthy male and female subjects, aged 18-80 years.
3. Body mass index between 18 and 35 kg/m2.
4. FEV1 ≥ 80% predicted.

Exclusion Criteria

1. 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.
2. Risk of non-compliance with study procedures.
3. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
4. 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.
5. History of lung disease including but not confined to COPD, asthma or pulmonary fibrosis.
6. History of latex allergy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes