SARS-CoV-2aeroCOVID1NCT04698837
Understanding Potential Airborne Transmission and the Protective Value of Type II Surgical Masks in SARS-CoV-2
An observational study of SARS-CoV-2, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- SARS-CoV-2
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Feb 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study is performed with hospitalized COVID-19 patients at Inselspital, Bern University hospital. The study site hospital is a tertiary university hospital treating COVID-19 patients on normal hospital wards as well as in the intensive care unit.
Who may be able to join
- 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
Who cannot join
- symptom onset more than 10 days prior to inclusion
- pregnancy
- lack of written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- SARS-CoV-2
- Keywords
- Airborne transmission, Aerosol transmission, Surgical masks
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of dummy-inhaled virus copies per 30 minutes sampling per size fraction (>10 µm, <10 µm)
Measured: 30 minutes sampling
Secondary outcomes (2)
Viability of dummy-inhaled viable virus per size fraction (>10 µm, and <10 µm)
Measured: 30 minutes sampling
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)
Measured: 30 minutes sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start2 Feb 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, Lucerne University of Applied Sciences and Arts
- Responsible party
- Sponsor
- Investigators
- Philipp Jent, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698837
- Sponsor's protocol ID
- 2020-02768
- Acronym
- aeroCOVID1
- Status last verified
- May 2022
- First submitted
- 4 Jan 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04698837
- Acronym / sponsor ID
- aeroCOVID1 / 2020-02768
- Conditions
- SARS-CoV-2
- Keywords
- Airborne transmission, Aerosol transmission, Surgical masks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern, Lucerne University of Applied Sciences and Arts
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is performed with hospitalized COVID-19 patients at Inselspital, Bern University hospital. The study site hospital is a tertiary university hospital treating COVID-19 patients on normal hospital wards as well as in the intensive care unit.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- symptom onset more than 10 days prior to inclusion
- pregnancy
- lack of written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total amount of dummy-inhaled virus copies per 30 minutes sampling per size fraction (>10 µm, <10 µm)
Time frame: 30 minutes sampling
2 secondary outcomes
Viability of dummy-inhaled viable virus per size fraction (>10 µm, and <10 µm)
Time frame: 30 minutes sampling
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)
Time frame: 30 minutes sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Jent, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of dummy-inhaled virus copies per 30 minutes sampling per size fraction (>10 µm, <10 µm) (time frame: 30 minutes sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.