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Novel Face Mask Sampling for COVID-19: A Diagnostic and Public Health Tool

NCT04481646 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 630

Last updated 2020-07-22

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

DIAGNOSTIC_TEST

Face mask sampling

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.

Sponsors & Collaborators

  • University Hospitals, Leicester

    collaborator OTHER

  • University of Leicester

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-12
Primary Completion
2022-06-30
Completion
2025-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04481646 on ClinicalTrials.gov