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

Quantification of Exhaled Particles to Identify Airborne Transmission Risks of SARS-Co-V-2

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Community Mask; Other: Surgical Mask; Other: FFP2 respirator; Other: FFP3 respirator

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Fraunhofer ITEM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: Community Mask; Fabric mask, no medical device; Other: Surgical Mask; Medical face mask (personal protective equipment), CE-certified; Other: FFP2 respirator; Filtering Face Piece with no less than 94% filtering capacity, CE-certified; Other: FFP3 respirator; Filtering Face Piece with no less than 99% filtering capacity, CE-certified

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Actual): August 20, 2021
• Study Completion (Actual): August 20, 2021

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Aerosols; Face mask; Exhaled particles
• Other Study ID Numbers: 20-14 QUELLE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No