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

Healthy Clinical Trial

— QUELLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771585
• Other study ID #: 20-14 QUELLE
• Status: Completed
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: August 20, 2021

Study information

• Verified date: August 2021
• Source: Fraunhofer-Institute of Toxicology and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Community Mask
Fabric mask, no medical device
• Surgical Mask
Medical face mask (personal protective equipment), CE-certified
• FFP2 respirator
Filtering Face Piece with no less than 94% filtering capacity, CE-certified
• FFP3 respirator
Filtering Face Piece with no less than 99% filtering capacity, CE-certified

Locations

Country	Name	City	State
Germany	Fraunhofer ITEM	Hannover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Fraunhofer-Institute of Toxicology and Experimental Medicine

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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)