Covid19COVMASKNCT04481646
Novel Face Mask Sampling for COVID-19: A Diagnostic and Public Health Tool
An observational study of Covid19, run by University of Leicester at 1 site in United Kingdom.
Trial summary
COVID-19 has become a global problem. There is an urgent need to improve the diagnosis and screening of patients and healthcare workers for COVID-19 in the UK. Mask based sampling is a method of detecting SARS-COV-2 (the virus responsible for COVID-19) in the breath of suspected COVID-19 patients or healthcare workers… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Face mask sampling
- How many people
- 630 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2020to Jun 2025
- How long will I take part?
- 21 Days
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: as previously described
Who may be able to join
- Not requiring oxygen by face mask
- Either:
- o Patients admitted to hospital with suspected COVID-19
- Or o Healthcare workers working within University Hospitals of Leicester, including those with and without symptoms suspicious of COVID-19.
Who cannot join
- Participants requiring oxygen by face mask (i.e., Venturi, non rebreathe)
- Participants with respiratory failure
- Medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the study
- Individuals who are unable to provide informed consent for themselves (i.e., individuals who lack capacity).
Trial locations and contacts
1 site in 1 country.
Caroline Williams, MbChB contact
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW
Manish Pareek, 0116 2541414, manish.pareek@leicester.ac.uk
About this study
Official title: The Efficacy and Feasibility of Face Mask Sampling for Hospitalised Adult Patients and Healthcare Workers With Suspected COVID-19
COVID-19 has become a global problem. There is an urgent need to improve the diagnosis and screening of patients and healthcare workers for COVID-19 in the UK. Mask based sampling is a method of detecting SARS-COV-2 (the virus responsible for COVID-19) in the breath of suspected COVID-19 patients or healthcare workers in the mask that they would wear in hospital. The investigators have previously demonstrated the utility of this method in other respiratory infections, such as tuberculosis.
This project aims to investigate the utility of mask-based sampling is a tool for the diagnosis and quantification of COVID-19 in breath and the implications in a healthcare setting using three cohorts of participants. Initially we will compare the amount of COVID-19 detected by mask sampling compared with standard nasopharyngeal swab, which is the current gold standard test, in patients who present to hospital with COVID-19 symptoms.
We will address the length of time COVID-19 is breathed out by people affected by the virus and the how infectious the virus is over time in a cohort of symptomatic healthcare workers who are isolating at home. This will allow us to understand how long someone stays infectious for and may have the potential to inform public health measures, for instance when healthcare workers can return to work or duration of isolation. Finally we will investigate asymptomatic carriage of COVID-19 by different healthcare workers in different areas of the hospital during a screening study. This will allow us to understand the extent of infection amongst healthcare workers and allow us to address hospital acquired transmission.
Read the detailed description
In order to understand the utility of face mask sampling for the diagnosis of COVID-19 and the public health implications, three cohorts of participants will be asked to take part in this study. Each participant will be asked to wear a modified face mask containing strips of sampling material for up to one hour and undertake a nasopharyngeal (nose/throat) swab concurrently. Depending on which cohort the participants are recruited to, the number of these 'sampling sessions' will vary. Basic demographic and microbiological data will be collected for every participant.
Cohort 1:
Patients admitted to hospital with COVID-19 symptoms will be approached to undertake a face mask sample and nasopharyngeal swab at two time points 12 hours apart on a single day whilst in hospital. Medical records will be accessed for basic clinical, demographic and microbiological data.
Cohort 2:
Healthcare workers who have report COVID-19 symptoms will be asked to undertake a face mask sample and nasophayngeal swab on days 1,3,5,7,10,14 and 21 of the study, for part of which they will be quarantined at home.
During this time they will complete a simple symptom diary. Members of the research team will visit their home to consent and train them on sampling techniques on day 1. Masks and swabs will then be left with them to complete.
These samples will then be collected at a mutually convenient time as teh samples are sample at room temperature for many days. If the healthcare worker does not feel able to complete self-sampling then a research team member will visit to undertake the sampling. Full PPE will be worn at all times and Staff working on the study will have NHS honorary contracts in place and will operate under University Hospitals of Leicester NHS Trust policies and procedures surrounding infection control and risk assessments whilst conducting this research. Medical records will be accessed for basic clinical, demographic and microbiological data. The results of the face mask sample are not intended to provide any diagnostic results and as such, the results will not be made available to the participant or the Occupational Health Department and HCWs will be directed to continue to follow the University Hospitals of Leicester NHS Trust policy when determining whether or not they are safe and able to return to work.
Cohort 3:
Healthcare workers from different areas of the hospital will be approached as part of a screening programme. They will be asked to undertake a single face mask and swab sample. Basic clinical and environmental data will be collected about each participant so they exposure risk can be stratified. The research team will work closely with the senior managers of each area to introduce the study to each participant so to minimise any stigmata related to deciding to participate or not. Any participant that has either a mask or swab positive result will be followed up and offered conventional screening as per Public Heath England's guidance. Staff working on the study will have NHS honorary contracts in place and will operate under University Hospitals of Leicester NHS Trust policies and procedures surrounding infection control and risk assessments whilst conducting this research. HCWs will be reminded that the results of the FSM are not conclusive and should not be used for diagnostic purposes. Each individual who produces a FSM+ sample will be referred back to the Trust Occupational Health Department for followup and management as per Trust policy.
- Conditions
- Covid19
- Being tested
- Face mask sampling
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face mask samplingDiagnostic test
Mask sampling consists of a modified face mask (flat surgical, duckbilled or FFP1) which contains up to strips of 3D printed Polyvinyl alcohol (PVA). As outlined in our previous work (ref lancet). These PVA strips are manufactured by the University of Leicester and measure approximately 50mm x 500mm and are fixed into place by adhesive pads. Mask assembly is conducted at the University of Leicester and are sterilised prior to use. Figure 3 and 4 shows examples of the inside of the mask with 4 strips placed inside and of how it is worn by study participants. The mask sampling system has been approved for previous studies in the UK, South Africa and The Gambia and has current approval for service improvement work at University Hospitals of Leicester NHS Trust for respiratory pathogens. It is awaiting approval as a medical device with the Medicines and Healthcare products Regulatory Agency.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients admitted to hospital with COVID-19 symptoms will be approached to undertake a face mask sample and nasopharyngeal swab at two time points 12 hours apart on a single day whilst in hospital. Medical records will be accessed for basic clinical, demographic and microbiological data. Receives: Diagnostic Test: Face mask sampling | |
| 2 | Healthcare workers who have report COVID-19 symptoms will be asked to undertake a face mask sample and nasophayngeal swab on days 1,3,5,7,10,14 and 21 of the study, for part of which they will be quarantined at home.During this time they will complete a simple symptom diary. Medical records will be accessed for basic clinical, demographic and microbiological data. Receives: Diagnostic Test: Face mask sampling | |
| 3 | Healthcare workers from different areas of the hospital will be approached as part of a screening programme. They will be asked to undertake a single face mask and swab sample. Basic clinical and environmental data will be collected about each participant so they exposure risk can be stratified. Receives: Diagnostic Test: Face mask sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison with Naso-pharyngeal swab
Newly diagnosed patients compare mask and swab samples taken at the same time
Measured: 6 months
Mask out over time
SARS-COV-2 RNA quantification over time SARS-COV-2 RNA quantification over 21 days post diagnosis
Measured: 12 months
mask as a screening tool in asymptomatic people
screening of asymptomatic healthcare workers
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start12 Jun 2020
- Primary completionJun 2022 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (estimated)
- Target duration
- 21 Days
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481646
- Sponsor's protocol ID
- 0775
- Acronym
- COVMASK
- Status last verified
- Jul 2020
- First submitted
- 21 Jul 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Feasibility of Face Mask Sampling for Hospitalised Adult Patients and Healthcare Workers With Suspected COVID-19
- ClinicalTrials.gov ID
- NCT04481646
- Acronym / sponsor ID
- COVMASK / 0775
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 22 Jul 2020 (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.
COVID-19 has become a global problem. There is an urgent need to improve the diagnosis and screening of patients and healthcare workers for COVID-19 in the UK. Mask based sampling is a method of detecting SARS-COV-2 (the virus responsible for COVID-19) in the breath of suspected COVID-19 patients or healthcare workers in the mask that they would wear in hospital. The investigators have previously demonstrated the utility of this method in other respiratory infections, such as tuberculosis.
This project aims to investigate the utility of mask-based sampling is a tool for the diagnosis and quantification of COVID-19 in breath and the implications in a healthcare setting using three cohorts of participants. Initially we will compare the amount of COVID-19 detected by mask sampling compared with standard nasopharyngeal swab, which is the current gold standard test, in patients who present to hospital with COVID-19 symptoms.
We will address the length of time COVID-19 is breathed out by people affected by the virus and the how infectious the virus is over time in a cohort of symptomatic healthcare workers who are isolating at home. This will allow us to understand how long someone stays infectious for and may have the potential to inform public health measures, for instance when healthcare workers can return to work or duration of isolation. Finally we will investigate asymptomatic carriage of COVID-19 by different healthcare workers in different areas of the hospital during a screening study. This will allow us to understand the extent of infection amongst healthcare workers and allow us to address hospital acquired transmission.
Detailed description
In order to understand the utility of face mask sampling for the diagnosis of COVID-19 and the public health implications, three cohorts of participants will be asked to take part in this study. Each participant will be asked to wear a modified face mask containing strips of sampling material for up to one hour and undertake a nasopharyngeal (nose/throat) swab concurrently. Depending on which cohort the participants are recruited to, the number of these 'sampling sessions' will vary. Basic demographic and microbiological data will be collected for every participant.
Cohort 1:
Patients admitted to hospital with COVID-19 symptoms will be approached to undertake a face mask sample and nasopharyngeal swab at two time points 12 hours apart on a single day whilst in hospital. Medical records will be accessed for basic clinical, demographic and microbiological data.
Cohort 2:
Healthcare workers who have report COVID-19 symptoms will be asked to undertake a face mask sample and nasophayngeal swab on days 1,3,5,7,10,14 and 21 of the study, for part of which they will be quarantined at home.
During this time they will complete a simple symptom diary. Members of the research team will visit their home to consent and train them on sampling techniques on day 1. Masks and swabs will then be left with them to complete.
These samples will then be collected at a mutually convenient time as teh samples are sample at room temperature for many days. If the healthcare worker does not feel able to complete self-sampling then a research team member will visit to undertake the sampling. Full PPE will be worn at all times and Staff working on the study will have NHS honorary contracts in place and will operate under University Hospitals of Leicester NHS Trust policies and procedures surrounding infection control and risk assessments whilst conducting this research. Medical records will be accessed for basic clinical, demographic and microbiological data. The results of the face mask sample are not intended to provide any diagnostic results and as such, the results will not be made available to the participant or the Occupational Health Department and HCWs will be directed to continue to follow the University Hospitals of Leicester NHS Trust policy when determining whether or not they are safe and able to return to work.
Cohort 3:
Healthcare workers from different areas of the hospital will be approached as part of a screening programme. They will be asked to undertake a single face mask and swab sample. Basic clinical and environmental data will be collected about each participant so they exposure risk can be stratified. The research team will work closely with the senior managers of each area to introduce the study to each participant so to minimise any stigmata related to deciding to participate or not. Any participant that has either a mask or swab positive result will be followed up and offered conventional screening as per Public Heath England's guidance. Staff working on the study will have NHS honorary contracts in place and will operate under University Hospitals of Leicester NHS Trust policies and procedures surrounding infection control and risk assessments whilst conducting this research. HCWs will be reminded that the results of the FSM are not conclusive and should not be used for diagnostic purposes. Each individual who produces a FSM+ sample will be referred back to the Trust Occupational Health Department for followup and management as per Trust policy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 21 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Face mask samplingPatients admitted to hospital with COVID-19 symptoms will be approached to undertake a face mask sample and nasopharyngeal swab at two time points 12 hours apart on a single day whilst in hospital. Medical records will be accessed for basic clinical, demographic and microbiological data. |
| 2 | – | Diagnostic Test: Face mask samplingHealthcare workers who have report COVID-19 symptoms will be asked to undertake a face mask sample and nasophayngeal swab on days 1,3,5,7,10,14 and 21 of the study, for part of which they will be quarantined at home.During this time they will complete a simple symptom diary. Medical records will be accessed for basic clinical, demographic and microbiological data. |
| 3 | – | Diagnostic Test: Face mask samplingHealthcare workers from different areas of the hospital will be approached as part of a screening programme. They will be asked to undertake a single face mask and swab sample. Basic clinical and environmental data will be collected about each participant so they exposure risk can be stratified. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- as previously described
Key inclusion criteria (4 listed)
- Not requiring oxygen by face mask
- Either:
- o Patients admitted to hospital with suspected COVID-19
- Or o Healthcare workers working within University Hospitals of Leicester, including those with and without symptoms suspicious of COVID-19.
Key exclusion criteria (4 listed)
- Participants requiring oxygen by face mask (i.e., Venturi, non rebreathe)
- Participants with respiratory failure
- Medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the study
- Individuals who are unable to provide informed consent for themselves (i.e., individuals who lack capacity).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face mask samplingMask sampling consists of a modified face mask (flat surgical, duckbilled or FFP1) which contains up to strips of 3D printed Polyvinyl alcohol (PVA). As outlined in our previous work (ref lancet). These PVA strips are manufactured by the University of Leicester and measure approximately 50mm x 500mm and are fixed into place by adhesive pads. Mask assembly is conducted at the University of Leicester and are sterilised prior to use. Figure 3 and 4 shows examples of the inside of the mask with 4 strips placed inside and of how it is worn by study participants. The mask sampling system has been approved for previous studies in the UK, South Africa and The Gambia and has current approval for service improvement work at University Hospitals of Leicester NHS Trust for respiratory pathogens. It is awaiting approval as a medical device with the Medicines and Healthcare products Regulatory Agency. | Diagnostic test | 1, 2, 3 |
Primary outcome
Comparison with Naso-pharyngeal swab
Time frame: 6 months
Newly diagnosed patients compare mask and swab samples taken at the same time
Mask out over time
Time frame: 12 months
SARS-COV-2 RNA quantification over time SARS-COV-2 RNA quantification over 21 days post diagnosis
mask as a screening tool in asymptomatic people
Time frame: 6 months
screening of asymptomatic healthcare workers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Caroline Williams, MbChB contact
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 Covid19, run by University of Leicester at 1 site in United Kingdom.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Jul 2020. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manish Pareek, MBChB PhD (01162541414, manish.pareek@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison with Naso-pharyngeal swab (time frame: 6 months). The study lists 3 primary outcomes in all. 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 22 Jul 2020.