<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04481646</url>
  </required_header>
  <id_info>
    <org_study_id>0775</org_study_id>
    <nct_id>NCT04481646</nct_id>
  </id_info>
  <brief_title>Novel Face Mask Sampling for COVID-19: A Diagnostic and Public Health Tool</brief_title>
  <acronym>COVMASK</acronym>
  <official_title>The Efficacy and Feasibility of Face Mask Sampling for Hospitalised Adult Patients and Healthcare Workers With Suspected COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leicester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospitals, Leicester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Leicester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      COVID-19 has become a global problem. There is an urgent need to improve the diagnosis and&#xD;
      screening of patients and healthcare workers for COVID-19 in the UK. Mask based sampling is a&#xD;
      method of detecting SARS-COV-2 (the virus responsible for COVID-19) in the breath of&#xD;
      suspected COVID-19 patients or healthcare workers in the mask that they would wear in&#xD;
      hospital. The investigators have previously demonstrated the utility of this method in other&#xD;
      respiratory infections, such as tuberculosis.&#xD;
&#xD;
      This project aims to investigate the utility of mask-based sampling is a tool for the&#xD;
      diagnosis and quantification of COVID-19 in breath and the implications in a healthcare&#xD;
      setting using three cohorts of participants. Initially we will compare the amount of COVID-19&#xD;
      detected by mask sampling compared with standard nasopharyngeal swab, which is the current&#xD;
      gold standard test, in patients who present to hospital with COVID-19 symptoms.&#xD;
&#xD;
      We will address the length of time COVID-19 is breathed out by people affected by the virus&#xD;
      and the how infectious the virus is over time in a cohort of symptomatic healthcare workers&#xD;
      who are isolating at home. This will allow us to understand how long someone stays infectious&#xD;
      for and may have the potential to inform public health measures, for instance when healthcare&#xD;
      workers can return to work or duration of isolation. Finally we will investigate asymptomatic&#xD;
      carriage of COVID-19 by different healthcare workers in different areas of the hospital&#xD;
      during a screening study. This will allow us to understand the extent of infection amongst&#xD;
      healthcare workers and allow us to address hospital acquired transmission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to understand the utility of face mask sampling for the diagnosis of COVID-19 and&#xD;
      the public health implications, three cohorts of participants will be asked to take part in&#xD;
      this study. Each participant will be asked to wear a modified face mask containing strips of&#xD;
      sampling material for up to one hour and undertake a nasopharyngeal (nose/throat) swab&#xD;
      concurrently. Depending on which cohort the participants are recruited to, the number of&#xD;
      these 'sampling sessions' will vary. Basic demographic and microbiological data will be&#xD;
      collected for every participant.&#xD;
&#xD;
      Cohort 1:&#xD;
&#xD;
      Patients admitted to hospital with COVID-19 symptoms will be approached to undertake a face&#xD;
      mask sample and nasopharyngeal swab at two time points 12 hours apart on a single day whilst&#xD;
      in hospital. Medical records will be accessed for basic clinical, demographic and&#xD;
      microbiological data.&#xD;
&#xD;
      Cohort 2:&#xD;
&#xD;
      Healthcare workers who have report COVID-19 symptoms will be asked to undertake a face mask&#xD;
      sample and nasophayngeal swab on days 1,3,5,7,10,14 and 21 of the study, for part of which&#xD;
      they will be quarantined at home.&#xD;
&#xD;
      During this time they will complete a simple symptom diary. Members of the research team will&#xD;
      visit their home to consent and train them on sampling techniques on day 1. Masks and swabs&#xD;
      will then be left with them to complete.&#xD;
&#xD;
      These samples will then be collected at a mutually convenient time as teh samples are sample&#xD;
      at room temperature for many days. If the healthcare worker does not feel able to complete&#xD;
      self-sampling then a research team member will visit to undertake the sampling. Full PPE will&#xD;
      be worn at all times and Staff working on the study will have NHS honorary contracts in place&#xD;
      and will operate under University Hospitals of Leicester NHS Trust policies and procedures&#xD;
      surrounding infection control and risk assessments whilst conducting this research. Medical&#xD;
      records will be accessed for basic clinical, demographic and microbiological data. The&#xD;
      results of the face mask sample are not intended to provide any diagnostic results and as&#xD;
      such, the results will not be made available to the participant or the Occupational Health&#xD;
      Department and HCWs will be directed to continue to follow the University Hospitals of&#xD;
      Leicester NHS Trust policy when determining whether or not they are safe and able to return&#xD;
      to work.&#xD;
&#xD;
      Cohort 3:&#xD;
&#xD;
      Healthcare workers from different areas of the hospital will be approached as part of a&#xD;
      screening programme. They will be asked to undertake a single face mask and swab sample.&#xD;
      Basic clinical and environmental data will be collected about each participant so they&#xD;
      exposure risk can be stratified. The research team will work closely with the senior managers&#xD;
      of each area to introduce the study to each participant so to minimise any stigmata related&#xD;
      to deciding to participate or not. Any participant that has either a mask or swab positive&#xD;
      result will be followed up and offered conventional screening as per Public Heath England's&#xD;
      guidance. Staff working on the study will have NHS honorary contracts in place and will&#xD;
      operate under University Hospitals of Leicester NHS Trust policies and procedures surrounding&#xD;
      infection control and risk assessments whilst conducting this research. HCWs will be reminded&#xD;
      that the results of the FSM are not conclusive and should not be used for diagnostic&#xD;
      purposes. Each individual who produces a FSM+ sample will be referred back to the Trust&#xD;
      Occupational Health Department for followup and management as per Trust policy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>21 Days</target_duration>
  <primary_outcome>
    <measure>Comparison with Naso-pharyngeal swab</measure>
    <time_frame>6 months</time_frame>
    <description>Newly diagnosed patients compare mask and swab samples taken at the same time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mask out over time</measure>
    <time_frame>12 months</time_frame>
    <description>SARS-COV-2 RNA quantification over time SARS-COV-2 RNA quantification over 21 days post diagnosis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mask as a screening tool in asymptomatic people</measure>
    <time_frame>6 months</time_frame>
    <description>screening of asymptomatic healthcare workers</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">630</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Face mask sampling</intervention_name>
    <description>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.</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
    <arm_group_label>3</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Face mask sample (exhaled sample)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        as previously described&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Not requiring oxygen by face mask&#xD;
&#xD;
          -  Either:&#xD;
&#xD;
             o Patients admitted to hospital with suspected COVID-19&#xD;
&#xD;
          -  Or o Healthcare workers working within University Hospitals of Leicester, including&#xD;
             those with and without symptoms suspicious of COVID-19.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants requiring oxygen by face mask (i.e., Venturi, non rebreathe)&#xD;
&#xD;
          -  Participants with respiratory failure&#xD;
&#xD;
          -  Medical history that might, in the opinion of the attending clinician, put the patient&#xD;
             at significant risk if he/she were to participate in the study&#xD;
&#xD;
          -  Individuals who are unable to provide informed consent for themselves (i.e.,&#xD;
             individuals who lack capacity).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Manish Pareek, MBChB PhD</last_name>
    <phone>01162541414</phone>
    <email>manish.pareek@leicester.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Caroline Williams, MbChB</last_name>
    <email>cw329@le.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospitals of Leicester NHS Trust</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Manish Pareek</last_name>
      <phone>0116 2541414</phone>
      <email>manish.pareek@leicester.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04481646
org study id: 0775
nct id: NCT04481646
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Comparison with Naso-pharyngeal swab
time frame: 6 months
description: Newly diagnosed patients compare mask and swab samples taken at the same time
measure: Mask out over time
time frame: 12 months
description: SARS-COV-2 RNA quantification over time SARS-COV-2 RNA quantification over 21 days post diagnosis
measure: mask as a screening tool in asymptomatic people
time frame: 6 months
description: screening of asymptomatic healthcare workers
arm group label: 1
description: 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.
arm group label: 2
description: 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.
arm group label: 3
description: 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.
intervention type: Diagnostic Test
intervention name: Face mask sampling
description: 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.
arm group label: 1
arm group label: 2
arm group label: 3
Face mask sample (exhaled sample)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Manish Pareek, MBChB PhD
phone: 01162541414
email: manish.pareek@leicester.ac.uk
last name: Caroline Williams, MbChB
email: cw329@le.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided