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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Community Mask; Other: Surgical Mask; Other: FFP2 respirator; Other: FFP3 respirator

• Registration Number: NCT04771585
• Lead Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-25
• Study Start: 2021-03-29
• Status Verified: 2021-08
• Primary Completion: 2021-08-20
• Study Completion: 2021-08-20
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Study Part B	Surgical Mask	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.
Study Part B	Community Mask	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.
Study Part B	FFP2 respirator	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.
Study Part B	FFP3 respirator	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.

Primary Outcome Measures

Name	Time	Method
To compare the emitted small particle fraction between various respiratory activities.	Day 1, Day 2 to 14	Change of particle number per time unit between tidal breathing and various respiratory activities.
To assess the influence of different face masks on the emitted small particle fraction of various respiratory activities.	After completion of Study part A (approximately 3 months)	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.

Secondary Outcome Measures

Name	Time	Method
To assess the influence of different face masks on the emitted particle size distribution of various respiratory activities.	After completion of Study part A (approximately 3 months)	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.
To assess the emitted particle size distribution of various respiratory activities.	Day 1, Day 2 to 14	Compare changes of emitted particle size spectrum as quantity per size range during tidal breathing and selected respiratory activities.
To assess the reproducibility of exhaled particle quantification.	Day 2 to 14	Compare results for particle number per time unit and particle size spectrum from visit 1 and 2.

Trial Locations

Locations (1)

Fraunhofer ITEM; 🇩🇪 Hannover, Niedersachsen, Germany