<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/NCT04459962</url>
  </required_header>
  <id_info>
    <org_study_id>2020ATL01</org_study_id>
    <nct_id>NCT04459962</nct_id>
  </id_info>
  <brief_title>Covid-19 Breath Test</brief_title>
  <official_title>Breath Test Feasibility Trial for Covid-19 Infection Diagnosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ancon Technologies Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ancon Technologies 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>
      Can Nanotechnology Biomarker Tagging (NBT) be used to detect COVID-19 infection in people&#xD;
      presenting for COVID-19 testing?&#xD;
&#xD;
      NBT can be used to detect the substances present in a person's breath. In this study the&#xD;
      breath of people presenting for COVID-19 testing is going to be analysed. Analysing a large&#xD;
      number of samples from people with COVID-19 (as confirmed by the standard swab test used by&#xD;
      the NHS) will enable a breath profile to be produced, ie the substances present in the breath&#xD;
      when someone has COVID-19. After the profile has been validated, NBT can be used to test&#xD;
      whether or not a person has COVID-19 by seeing if their breath matches the profile.&#xD;
&#xD;
      Using this technology for COVID-19 testing has advantages over the current standard test. The&#xD;
      sample can be analysed immediately in the clinical setting and the results are available in&#xD;
      5-10 minutes, so if the person tests negative they can go back to their normal life straight&#xD;
      away. The current swab test takes around 72 hours for the results to be available, and the&#xD;
      person needs to self-isolate during this time in case they test positive, resulting in&#xD;
      potentially unnecessary days of work missed and inconvenience. The breath test is&#xD;
      non-invasive and is unlikely to cause any discomfort, as the person is only required to&#xD;
      breath normally into the device. This study will also review the practicalities of using this&#xD;
      test. It is quick and easy to train people in how to carry out the test, so it could&#xD;
      potentially easily be rolled out to testing sites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Cohort Study which will collect non-invasive, expired breath sample, cheek swab and&#xD;
      a Medical and Lifestyle questionnaire from participants.&#xD;
&#xD;
      When the participant presents for COVID-19 testing they will be asked to provide a cheek swab&#xD;
      and breath sample, and complete the study questionnaire. They will not need to give any&#xD;
      identifiable information or have a second visit. The samples will be analysed immediately and&#xD;
      disposed of as clinical waste. ANCON will then use the data to build a breath profile of&#xD;
      COVID-19 infection.&#xD;
&#xD;
      Sample and data collection method for inpatients:&#xD;
&#xD;
        -  Sequential (daily or every other day as able) breath and swab test will be taken from&#xD;
           some of the patients admitted in the hospital (inpatients).&#xD;
&#xD;
        -  This will be taken from entry or start of the study to discharge or end of study or&#xD;
           until patient or medical staff deem unsuitable to continue&#xD;
&#xD;
        -  This will enable to track infection and the relevant profile changes as covid-19&#xD;
           progresses and/or is treated. This will provide vital additional information around&#xD;
           identifiers associated with the disease and its progress.&#xD;
&#xD;
      Anonymous Questionnaire - Each participant will be asked questions in the form of a short&#xD;
      standard questionnaire based on:&#xD;
&#xD;
        -  Medical Information&#xD;
&#xD;
        -  Lifestyle Information&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Actual">January 7, 2021</completion_date>
  <primary_completion_date type="Actual">January 7, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Participants who are Covid-19 negative, Covid-19 positive or suspected with Covid-19 infection will be recruited</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To investigate/ examine the effectiveness of Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients with COVID-19 symptoms</measure>
    <time_frame>6 Months</time_frame>
    <description>This will be measured by identification of VOCs present in the breath sample of the COVID-19 positive and their relative concentrations compared to a COVID-19 negative breath sample. These will be combined to provide a COVID-19 positive profile</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>-To profile the unique pattern of Volatile Organic Compounds (VOCs) found in the expired breath of COVID-19 patients using the NBT system (VOC analysis and ML).</measure>
    <time_frame>6 months</time_frame>
    <description>This will be measured by identification of VOCs present in the breath sample of the COVID-19 positive and their relative concentrations compared to a COVID-19 negative breath sample using ML. These will be combined to provide a COVID-19 positive profile.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To differentiate this unique profile from the patients that are found to be negative for COVID-19</measure>
    <time_frame>6 months</time_frame>
    <description>The patient samples that return COVID-19 negative will be used as controls for identification of VOCs and relative concentrations that are common to all samples.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">330</enrollment>
  <condition>Covid-19 Infection</condition>
  <arm_group>
    <arm_group_label>Study Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Breath Test and Cheek Swab collection</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Breath Test &amp; Cheek Swab</intervention_name>
    <description>Breath Sample and Cheek Swab of participants will be used for machine learning (NBT - Nanobiotechnology Biomarkers Tagging) system to develop a profile which can be used later on for Covid-19 Diagnosis.</description>
    <arm_group_label>Study Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male &amp; Females.&#xD;
&#xD;
          -  Age Above 16 years old&#xD;
&#xD;
          -  All Ethnicity&#xD;
&#xD;
          -  Any patients that come for COVID-19 testing&#xD;
&#xD;
          -  COVID Negative Patients (Further participants may be selected as control groups who&#xD;
             have no current diagnosis of COVID-19.)&#xD;
&#xD;
          -  COVID Positive In-Patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Outside of stated age range - below 16&#xD;
&#xD;
          -  Unable to consent&#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_official>
    <last_name>Stephen Winchester, MBBS, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ashford and St Peter's Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ashford and St Peter's Hospitals NHS Foundation Trust</name>
      <address>
        <city>Chertsey</city>
        <state>Surrey</state>
        <zip>KT16 0PZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Ajibola OA, Smith D, Spanel P, Ferns GA. Effects of dietary nutrients on volatile breath metabolites. J Nutr Sci. 2013 Oct 31;2:e34. doi: 10.1017/jns.2013.26. eCollection 2013.</citation>
    <PMID>25191584</PMID>
  </reference>
  <reference>
    <citation>Smith D, Spanel P. The challenge of breath analysis for clinical diagnosis and therapeutic monitoring. Analyst. 2007 May;132(5):390-6. doi: 10.1039/b700542n. Epub 2007 Mar 19.</citation>
    <PMID>17471381</PMID>
  </reference>
  <reference>
    <citation>Amann A, Spanel P, Smith D. Breath analysis: the approach towards clinical applications. Mini Rev Med Chem. 2007 Feb;7(2):115-29. doi: 10.2174/138955707779802606.</citation>
    <PMID>17305586</PMID>
  </reference>
  <reference>
    <citation>Gouma PI, Wang L, Simon SR, Stanacevic M. Novel Isoprene Sensor for a Flu Virus Breath Monitor. Sensors (Basel). 2017 Jan 20;17(1):199. doi: 10.3390/s17010199.</citation>
    <PMID>28117692</PMID>
  </reference>
  <reference>
    <citation>Kim, K.-H.Kim., Jahan, S.A., Kabir, E., (2012) A review of breath analysis for diagnosis of human health. TrAC Trends in Analytical Chemistry. v.33, 1-8. https://doi.org/10.1016/j.trac.2011.09.013</citation>
  </reference>
  <reference>
    <citation>Lake MA. What we know so far: COVID-19 current clinical knowledge and research. Clin Med (Lond). 2020 Mar;20(2):124-127. doi: 10.7861/clinmed.2019-coron. Epub 2020 Mar 5.</citation>
    <PMID>32139372</PMID>
  </reference>
  <reference>
    <citation>Marczin N, Kharitonov S (2003) Lung Biology in Health and Disease. Disease Markers in Exhaled Breath Edited by: New York: Marcel Dekker; 2003.</citation>
  </reference>
  <reference>
    <citation>NHS-England, (2020) Guidance and standard operating procedure COVID-19 virus testing in NHS laboratories.</citation>
  </reference>
  <reference>
    <citation>Sethi S, Nanda R, Chakraborty T. Clinical application of volatile organic compound analysis for detecting infectious diseases. Clin Microbiol Rev. 2013 Jul;26(3):462-75. doi: 10.1128/CMR.00020-13.</citation>
    <PMID>23824368</PMID>
  </reference>
  <reference>
    <citation>Risby T., (2005): Current status of clinical breath analysis. In Breath Analysis for Clinical Diagnosis and Therapeutic Monitoring Edited by: Amann A, Smith D. Singapore: World Scientific; 2005:251-265.</citation>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</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>Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <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/NCT04459962
org study id: 2020ATL01
nct id: NCT04459962
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Can Nanotechnology Biomarker Tagging (NBT) be used to detect COVID-19 infection in people
      presenting for COVID-19 testing?

      NBT can be used to detect the substances present in a person's breath. In this study the
      breath of people presenting for COVID-19 testing is going to be analysed. Analysing a large
      number of samples from people with COVID-19 (as confirmed by the standard swab test used by
      the NHS) will enable a breath profile to be produced, ie the substances present in the breath
      when someone has COVID-19. After the profile has been validated, NBT can be used to test
      whether or not a person has COVID-19 by seeing if their breath matches the profile.

      Using this technology for COVID-19 testing has advantages over the current standard test. The
      sample can be analysed immediately in the clinical setting and the results are available in
      5-10 minutes, so if the person tests negative they can go back to their normal life straight
      away. The current swab test takes around 72 hours for the results to be available, and the
      person needs to self-isolate during this time in case they test positive, resulting in
      potentially unnecessary days of work missed and inconvenience. The breath test is
      non-invasive and is unlikely to cause any discomfort, as the person is only required to
      breath normally into the device. This study will also review the practicalities of using this
      test. It is quick and easy to train people in how to carry out the test, so it could
      potentially easily be rolled out to testing sites.
This is a Cohort Study which will collect non-invasive, expired breath sample, cheek swab and
      a Medical and Lifestyle questionnaire from participants.

      When the participant presents for COVID-19 testing they will be asked to provide a cheek swab
      and breath sample, and complete the study questionnaire. They will not need to give any
      identifiable information or have a second visit. The samples will be analysed immediately and
      disposed of as clinical waste. ANCON will then use the data to build a breath profile of
      COVID-19 infection.

      Sample and data collection method for inpatients:

        -  Sequential (daily or every other day as able) breath and swab test will be taken from
           some of the patients admitted in the hospital (inpatients).

        -  This will be taken from entry or start of the study to discharge or end of study or
           until patient or medical staff deem unsuitable to continue

        -  This will enable to track infection and the relevant profile changes as covid-19
           progresses and/or is treated. This will provide vital additional information around
           identifiers associated with the disease and its progress.

      Anonymous Questionnaire - Each participant will be asked questions in the form of a short
      standard questionnaire based on:

        -  Medical Information

        -  Lifestyle Information
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Participants who are Covid-19 negative, Covid-19 positive or suspected with Covid-19 infection will be recruited
primary purpose: Diagnostic
masking: None (Open Label)
measure: To investigate/ examine the effectiveness of Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients with COVID-19 symptoms
time frame: 6 Months
description: This will be measured by identification of VOCs present in the breath sample of the COVID-19 positive and their relative concentrations compared to a COVID-19 negative breath sample. These will be combined to provide a COVID-19 positive profile
measure: -To profile the unique pattern of Volatile Organic Compounds (VOCs) found in the expired breath of COVID-19 patients using the NBT system (VOC analysis and ML).
time frame: 6 months
description: This will be measured by identification of VOCs present in the breath sample of the COVID-19 positive and their relative concentrations compared to a COVID-19 negative breath sample using ML. These will be combined to provide a COVID-19 positive profile.
measure: To differentiate this unique profile from the patients that are found to be negative for COVID-19
time frame: 6 months
description: The patient samples that return COVID-19 negative will be used as controls for identification of VOCs and relative concentrations that are common to all samples.
arm group label: Study Arm
arm group type: Experimental
description: Breath Test and Cheek Swab collection
intervention type: Diagnostic Test
intervention name: Breath Test & Cheek Swab
description: Breath Sample and Cheek Swab of participants will be used for machine learning (NBT - Nanobiotechnology Biomarkers Tagging) system to develop a profile which can be used later on for Covid-19 Diagnosis.
arm group label: Study Arm
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen Winchester, MBBS, MSc
role: Principal Investigator
affiliation: Ashford and St Peter's Hospitals NHS Foundation Trust
facility: 
country: United Kingdom
citation: Ajibola OA, Smith D, Spanel P, Ferns GA. Effects of dietary nutrients on volatile breath metabolites. J Nutr Sci. 2013 Oct 31;2:e34. doi: 10.1017/jns.2013.26. eCollection 2013.
PMID: 25191584
citation: Smith D, Spanel P. The challenge of breath analysis for clinical diagnosis and therapeutic monitoring. Analyst. 2007 May;132(5):390-6. doi: 10.1039/b700542n. Epub 2007 Mar 19.
PMID: 17471381
citation: Amann A, Spanel P, Smith D. Breath analysis: the approach towards clinical applications. Mini Rev Med Chem. 2007 Feb;7(2):115-29. doi: 10.2174/138955707779802606.
PMID: 17305586
citation: Gouma PI, Wang L, Simon SR, Stanacevic M. Novel Isoprene Sensor for a Flu Virus Breath Monitor. Sensors (Basel). 2017 Jan 20;17(1):199. doi: 10.3390/s17010199.
PMID: 28117692
citation: Kim, K.-H.Kim., Jahan, S.A., Kabir, E., (2012) A review of breath analysis for diagnosis of human health. TrAC Trends in Analytical Chemistry. v.33, 1-8. https://doi.org/10.1016/j.trac.2011.09.013
citation: Lake MA. What we know so far: COVID-19 current clinical knowledge and research. Clin Med (Lond). 2020 Mar;20(2):124-127. doi: 10.7861/clinmed.2019-coron. Epub 2020 Mar 5.
PMID: 32139372
citation: Marczin N, Kharitonov S (2003) Lung Biology in Health and Disease. Disease Markers in Exhaled Breath Edited by: New York: Marcel Dekker; 2003.
citation: NHS-England, (2020) Guidance and standard operating procedure COVID-19 virus testing in NHS laboratories.
citation: Sethi S, Nanda R, Chakraborty T. Clinical application of volatile organic compound analysis for detecting infectious diseases. Clin Microbiol Rev. 2013 Jul;26(3):462-75. doi: 10.1128/CMR.00020-13.
PMID: 23824368
citation: Risby T., (2005): Current status of clinical breath analysis. In Breath Analysis for Clinical Diagnosis and Therapeutic Monitoring Edited by: Amann A, Smith D. Singapore: World Scientific; 2005:251-265.
responsible party type: Sponsor
mesh term: Infections
mesh term: COVID-19
sharing ipd: No