<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/NCT04467112</url>
  </required_header>
  <id_info>
    <org_study_id>COVID-Breath</org_study_id>
    <nct_id>NCT04467112</nct_id>
  </id_info>
  <brief_title>Non Inferiority Trial for Detection of nCOVID-19 Through Analysis of Exhaled Breath Aerosols</brief_title>
  <official_title>Non Inferiority Trial for Detection of nCOVID-19 Through Analysis of Exhaled Breath Aerosols</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Owlstone Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cambridge University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Owlstone Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate several of Owlstone Medical's Breath Biopsy aerosol respiratory&#xD;
      droplet capture techniques for the detection of nCOVID-19.&#xD;
&#xD;
      These are single use disposable breath capture devices with removable filters and fitted PVA&#xD;
      strip that directly sample exhaled breath aerosols and therefore, directly sample the primary&#xD;
      transmission route for the virus. They can be used independently and shipped for analysis for&#xD;
      the presence of nCOVID-19 using established existing assays available in any reference lab.&#xD;
&#xD;
      The trial is a non-inferiority trial comparing diagnostic accuracy of collection via face&#xD;
      mask vs. available diagnostic procedures in standard care and will also asses the feasibility&#xD;
      of patient use of the equipment.&#xD;
&#xD;
      Subjects will be recruited at the Addenbrookes Hospital, Cambridge. Minimal patient&#xD;
      characteristics (e.g. age, sex) are collected.&#xD;
&#xD;
      Between 20 and 100 subjects with with a positive nCOVID-19 diagnosis will be sampled to&#xD;
      obtain to address the primary study hypothesis. Due to the pre-test probability of patients&#xD;
      being positive for nCOVID-19 is unknown we will monitor the number of sampled subjects with a&#xD;
      positive diagnosis on a weekly basis. The clinical diagnosis of the subject based on a&#xD;
      combination of imaging, viral diagnostics and clinical assessment will be used as the&#xD;
      reference standard. When this number hits 100 the study will be discontinued. In total no&#xD;
      more than 500 subjects shall be sampled in this trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be recruited for the study during their scheduled appointments per clinical&#xD;
      practice to the site, no separate study visit is required.&#xD;
&#xD;
      The participant's involvement in the study will be limited to one visit (per routine&#xD;
      practice) only. No additional follow up is required.&#xD;
&#xD;
      For the purpose of the study a breath sample will be collected using the Breath Biopsy face&#xD;
      masks. Collection of exhaled breath aerosols using these single use, disposable face masks&#xD;
      will require subjects to breath normally into these face masks, the total collection time&#xD;
      will not exceed one hour. It is expected to reduce collection times after initial validation&#xD;
      steps to the shortest time providing sufficient diagnostic accuracy.&#xD;
&#xD;
      Given the non-invasive nature of these breath collections subjects can immediately provide up&#xD;
      to two samples using the Breath Biopsy face masks. The breath collection should occur within&#xD;
      24 hours of the diagnostic sample.&#xD;
&#xD;
      Collected samples will be either frozen or shipped for rtPCR analysis of the presence of&#xD;
      nCOVID-19 RNA. The two Breath Biopsy face masks can be used as technical replicates and/or to&#xD;
      validate different storage conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Actual">December 19, 2020</completion_date>
  <primary_completion_date type="Actual">December 19, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of nCOVID-19 using a face mask</measure>
    <time_frame>1 year</time_frame>
    <description>The primary aim of this study is to establish non-inferiority of the Breath Biopsy face masks with various respiratory droplet (aerosol) capture techniques for the detection of nCOVID-19 compared to the current diagnostic test results per standard practice.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Independent Patient use of face mask</measure>
    <time_frame>1 year</time_frame>
    <description>The secondary objective is to assess the feasibility of independent use of the Breath Biopsy face masks. This will be measured by means of patient reported feedback on their level of comfort in performing the breath collection</description>
  </secondary_outcome>
  <enrollment type="Actual">8</enrollment>
  <condition>COVID</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Breath Biopsy face masks with removable filters and fitted PVA strip</intervention_name>
    <description>Device developed for collection of breath samples</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The face mask will be placed onto the subject's face, covering his/her nose and mouth, head&#xD;
      straps will be used to ensure that the face mask is kept in place for the duration of the&#xD;
      test. This mask will contain a material designed to capture exhaled respiratory droplets&#xD;
      and/or aerosols. Several iterations of these impaction and filtration devices may be used to&#xD;
      optimize functional attributes of the material for capture of COVID. These materials will&#xD;
      always have a proven safety for use with humans.&#xD;
&#xD;
      Subjects can talk, cough and sneeze in the mask or can temporarily remove the mask if&#xD;
      uncomfortable, to drink some water etc if required. Total collection time spread across two&#xD;
      masks will not exceed one hour&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The inclusion and exclusion criteria for the various study populations are detailed above.&#xD;
        General inclusion and exclusion criteria which apply to all study subjects are detailed&#xD;
        followed by indication specific criteria are also detailed for both inclusion and&#xD;
        exclusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provide written informed consent&#xD;
&#xD;
          -  Be 16 years or older&#xD;
&#xD;
          -  Suspected or confirmed nCOVID-19 infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects unable to provide written informed consent&#xD;
&#xD;
          -  Ineligible subjects will specifically include subjects:&#xD;
&#xD;
               -  deemed unlikely to be able to maintain oxygen saturation of greater than 90%&#xD;
                  while breathing room air for 30 seconds Require non-invasive ventilation or high&#xD;
                  flow nasal oxygen&#xD;
&#xD;
               -  who require inotropic medication to maintain adequate organ perfusion&#xD;
&#xD;
               -  communication barrier and / or unable to comply with the instructions to use the&#xD;
                  Breath Biopsy face masks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stefan Marciniak</last_name>
    <role>Study Chair</role>
    <affiliation>Cambridge Institute for Medical Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cambridge University Hospital NHS</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04467112
org study id: COVID-Breath
nct id: NCT04467112
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate several of Owlstone Medical's Breath Biopsy aerosol respiratory
      droplet capture techniques for the detection of nCOVID-19.

      These are single use disposable breath capture devices with removable filters and fitted PVA
      strip that directly sample exhaled breath aerosols and therefore, directly sample the primary
      transmission route for the virus. They can be used independently and shipped for analysis for
      the presence of nCOVID-19 using established existing assays available in any reference lab.

      The trial is a non-inferiority trial comparing diagnostic accuracy of collection via face
      mask vs. available diagnostic procedures in standard care and will also asses the feasibility
      of patient use of the equipment.

      Subjects will be recruited at the Addenbrookes Hospital, Cambridge. Minimal patient
      characteristics (e.g. age, sex) are collected.

      Between 20 and 100 subjects with with a positive nCOVID-19 diagnosis will be sampled to
      obtain to address the primary study hypothesis. Due to the pre-test probability of patients
      being positive for nCOVID-19 is unknown we will monitor the number of sampled subjects with a
      positive diagnosis on a weekly basis. The clinical diagnosis of the subject based on a
      combination of imaging, viral diagnostics and clinical assessment will be used as the
      reference standard. When this number hits 100 the study will be discontinued. In total no
      more than 500 subjects shall be sampled in this trial.
Subjects will be recruited for the study during their scheduled appointments per clinical
      practice to the site, no separate study visit is required.

      The participant's involvement in the study will be limited to one visit (per routine
      practice) only. No additional follow up is required.

      For the purpose of the study a breath sample will be collected using the Breath Biopsy face
      masks. Collection of exhaled breath aerosols using these single use, disposable face masks
      will require subjects to breath normally into these face masks, the total collection time
      will not exceed one hour. It is expected to reduce collection times after initial validation
      steps to the shortest time providing sufficient diagnostic accuracy.

      Given the non-invasive nature of these breath collections subjects can immediately provide up
      to two samples using the Breath Biopsy face masks. The breath collection should occur within
      24 hours of the diagnostic sample.

      Collected samples will be either frozen or shipped for rtPCR analysis of the presence of
      nCOVID-19 RNA. The two Breath Biopsy face masks can be used as technical replicates and/or to
      validate different storage conditions.
observational model: Cohort
time perspective: Cross-Sectional
measure: Detection of nCOVID-19 using a face mask
time frame: 1 year
description: The primary aim of this study is to establish non-inferiority of the Breath Biopsy face masks with various respiratory droplet (aerosol) capture techniques for the detection of nCOVID-19 compared to the current diagnostic test results per standard practice.
measure: Independent Patient use of face mask
time frame: 1 year
description: The secondary objective is to assess the feasibility of independent use of the Breath Biopsy face masks. This will be measured by means of patient reported feedback on their level of comfort in performing the breath collection
intervention type: Device
intervention name: Breath Biopsy face masks with removable filters and fitted PVA strip
description: Device developed for collection of breath samples
The face mask will be placed onto the subject's face, covering his/her nose and mouth, head
      straps will be used to ensure that the face mask is kept in place for the duration of the
      test. This mask will contain a material designed to capture exhaled respiratory droplets
      and/or aerosols. Several iterations of these impaction and filtration devices may be used to
      optimize functional attributes of the material for capture of COVID. These materials will
      always have a proven safety for use with humans.

      Subjects can talk, cough and sneeze in the mask or can temporarily remove the mask if
      uncomfortable, to drink some water etc if required. Total collection time spread across two
      masks will not exceed one hour
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Stefan Marciniak
role: Study Chair
affiliation: Cambridge Institute for Medical Research
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No