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

Fraunhofer-Institute of Toxicology and Experimental Medicine

Status: Completed

Conditions: Healthy

Treatments: Other: FFP2 respirator; Other: Surgical Mask; Other: FFP3 respirator; Other: Community Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT04771585

20-14 QUELLE

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Study Part A

No Intervention group

Description:

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.

Study Part B

Experimental group

Description:

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.

Treatment:

Other: Surgical Mask

Other: Community Mask

Other: FFP3 respirator

Other: FFP2 respirator