Clinical trial NCT04771585: Quantification of Exhaled Particles to Identify Airborne Transmission Risks of COVID-19
Official title: Quantification of Exhaled Particles to Identify Airborne Transmission Risks of SARS-Co-V-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Aerosols
Exhaled particles
Face mask
Lead sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To compare the emitted small particle fraction between various respiratory activities.
timeFrame: Day 1, Day 2 to 14
measure: To assess the influence of different face masks on the emitted small particle fraction of various respiratory activities.
timeFrame: After completion of Study part A (approximately 3 months)
Secondary outcomes:
measure: To assess the emitted particle size distribution of various respiratory activities.
timeFrame: Day 1, Day 2 to 14
measure: To assess the reproducibility of exhaled particle quantification.
timeFrame: Day 2 to 14
measure: To assess the influence of different face masks on the emitted particle size distribution of various respiratory activities.
timeFrame: After completion of Study part A (approximately 3 months)
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Fraunhofer ITEM
state: Niedersachsen
Study officials:
References: