Skip to main content
OpenTrials
Completed

NCT Number: NCT04771585

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fraunhofer ITEM

Hanover, Lower Saxony, 30625, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Community Mask

Other

Fabric mask, no medical device

Surgical Mask

Other

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

FFP2 respirator

Other

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

FFP3 respirator

Other

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

Primary outcomes

  1. To compare the emitted small particle fraction between various respiratory activities.

    Time frame: Day 1, Day 2 to 14

    Change of particle number per time unit between tidal breathing and various respiratory activities.

  2. To assess the influence of different face masks on the emitted small particle fraction of various respiratory activities.

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. To assess the reproducibility of exhaled particle quantification.

    Time frame: Day 2 to 14

    Compare results for particle number per time unit and particle size spectrum from visit 1 and 2.

  3. To assess the influence of different face masks on the emitted particle size distribution of various respiratory activities.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fraunhofer-Institute of Toxicology and Experimental Medicine

Other

Registry information

Official study title

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

Acronym: QUELLE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2021
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.