Novel Face Mask Sampling for COVID-19: A Diagnostic and Public Health Tool
COVMASK
The Efficacy and Feasibility of Face Mask Sampling for Hospitalised Adult Patients and Healthcare Workers With Suspected COVID-19
1 other identifier
observational
630
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2020
CompletedFirst Submitted
Initial submission to the registry
July 21, 2020
CompletedFirst Posted
Study publicly available on registry
July 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedJuly 22, 2020
July 1, 2020
2 years
July 21, 2020
July 21, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Comparison with Naso-pharyngeal swab
Newly diagnosed patients compare mask and swab samples taken at the same time
6 months
Mask out over time
SARS-COV-2 RNA quantification over time SARS-COV-2 RNA quantification over 21 days post diagnosis
12 months
mask as a screening tool in asymptomatic people
screening of asymptomatic healthcare workers
6 months
Study Arms (3)
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.
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.
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.
Interventions
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.
Eligibility Criteria
as previously described
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leicesterlead
- University Hospitals, Leicestercollaborator
Study Sites (1)
University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW, United Kingdom
Biospecimen
Face mask sample (exhaled sample)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 21 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2020
First Posted
July 22, 2020
Study Start
June 12, 2020
Primary Completion
June 1, 2022
Study Completion
June 1, 2025
Last Updated
July 22, 2020
Record last verified: 2020-07