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

NCT04771585 | Completed

• 1 other identifier: 20-14 QUELLE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Aerosols; Exhaled particles; Face mask

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• To assess the emitted particle size distribution of various respiratory activities.

  Day 1, Day 2 to 14

• To assess the reproducibility of exhaled particle quantification.

  Day 2 to 14

• 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)

Study Arms (2)

Study Part A

NO INTERVENTION

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

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

Interventions

Community Mask OTHER

Fabric mask, no medical device

Study Part B

Surgical Mask OTHER

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

Study Part B

FFP2 respirator OTHER

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

Study Part B

FFP3 respirator OTHER

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

Study Part B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead

Study Sites (1)

Fraunhofer ITEM

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (1)

• Schwarz K, Struss N, Banari L, Hohlfeld JM. Quantifying Exhaled Particles in Healthy Humans During Various Respiratory Activities Under Realistic Conditions. J Aerosol Med Pulm Drug Deliv. 2024 Apr;37(2):51-63. doi: 10.1089/jamp.2022.0076. Epub 2024 Jan 29.

  PMID: 38285475 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 25, 2021
• Study Start: March 29, 2021
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)