aeroCOVID1: Understanding Potential Airborne Transmission and the Protective Value of Type II Surgical Masks in SARS-CoV-2

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Completed
CT.gov ID
NCT04698837
Collaborator
University of Bern (Other), Lucerne University of Applied Sciences and Arts (Other)
30
1
10.9
2.8

Study Details

Study Description

Brief Summary

Modes of transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and specifically the proportion of airborne transmission in this infection is unknown. In the aeroCOVID study, a highly efficient bioaerosol and droplet sampling dummy is used to emulate a susceptible healthcare worker (HCW) and to perform patient proximity sampling. The dummy will measure the dummy-inhaled dose of SARS-CoV-2 in two particle size fractions in a standardized interaction with hospitalized coronavirus disease 2019 (COVID-19) patients. All measurements are performed in a masked and unmasked dummy setup in parallel, in order to gain further information on the protection of type II masks against the respective particle size exposure.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Modes of interpersonal transmission in SARS-CoV-2 are to date only incompletely understood and require further investigation in order to define best preventive measures. Although a dichotomization of inhaled particles by particle size is an oversimplification and a large particle size does not exclude shortterm airborne behavior, the suspension time of virus containing particles and the probability of particles to accumulate in room air is primarily defined by particle size distribution. Particles with a size below 10 µm have a high probability of accumulation due to their mean suspension time of minutes to hours.

    The study aims to measure the total amount of virus copies per particle size fraction inhaled by a highly efficient sampling dummy emulating a susceptible HCW in a standardized interaction with hospitalized COVID-19 patients. As a secondary endpoint, the proportion of culturable virus in each setup is measured as well.

    Sampling is done in using two parallel bioaerosol and droplet sampling dummies - one type II masked and one with an unmasked dummy head as inlet - in order to gain additional information on the protective effect of type II surgical masks in a real-life exhaled particle size distribution in hospitalized COVID patients. The sampling dummy consists of a real size face relief connected to an 60° inlet cone, a cyclone for collection of particles >10 µm and a laminar flow water-based condensation bioaerosol collector for particle collection below 10 µm particle size.

    After patient proximity sampling, a nasopharyngeal swab for SARS-CoV-2 polymerase chain reaction (PCR) assay is performed. Relevant indoor climate parameters like temperature, humidity and carbon dioxide (CO2) as well as room characteristics as air change rate are recorded as well.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    AeroCOVID 1: Understanding Potential Airborne Transmission and the Protective Value of Type II Surgical Masks in SARS-CoV-2 Using Patient Proximity Environmental Sampling With a Highly Efficient Bioaerosol and Droplet Collection Dummy
    Actual Study Start Date :
    Feb 2, 2021
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Total amount of dummy-inhaled virus copies per 30 minutes sampling per size fraction (>10 µm, <10 µm) [30 minutes sampling]

    Secondary Outcome Measures

    1. Viability of dummy-inhaled viable virus per size fraction (>10 µm, and <10 µm) [30 minutes sampling]

    2. Reduction of dummy-inhaled virus copies per 30 minutes sampling in a type II-masked setup, as compared to unmasked, per size fraction (>10 µm, <10 µm) [30 minutes sampling]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 110 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • positive SARS-CoV-2 PCR or antigen test from a nasopharyngeal or oropharyngeal swab

    • ≥18 years of age

    • ability to give consent

    • ability to follow simple instructions

    Exclusion Criteria:
    • symptom onset more than 10 days prior to inclusion

    • pregnancy

    • lack of written informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Bern Bern Switzerland

    Sponsors and Collaborators

    • University Hospital Inselspital, Berne
    • University of Bern
    • Lucerne University of Applied Sciences and Arts

    Investigators

    • Principal Investigator: Philipp Jent, MD, University of Bern

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital Inselspital, Berne
    ClinicalTrials.gov Identifier:
    NCT04698837
    Other Study ID Numbers:
    • 2020-02768
    First Posted:
    Jan 7, 2021
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital Inselspital, Berne

    Study Results

    No Results Posted as of May 18, 2022