<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/NCT04403906</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS283137</org_study_id>
    <nct_id>NCT04403906</nct_id>
  </id_info>
  <brief_title>Somerset and South Essex Coronavirus Antigen Testing</brief_title>
  <acronym>SOCRATES</acronym>
  <official_title>Evaluation of the PCL Rapid Point of Care Antigen Test for Severe Acute Respiratory Syndrome Coronavirus 2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Somerset NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Somerset NHS Foundation Trust</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 is to evaluate the utility of the PCL Rapid Antigen Test for Coronavirus&#xD;
      (COVID-19) in a real world clinical setting. The PCL test has completed laboratory validation&#xD;
      and holds a European CE marking for in vitro diagnostic devices. These tests have been made&#xD;
      available to South West Pathology Services as a donation in kind by iPP (Integrated Pathology&#xD;
      Partnership). They have been widely used in South Korea.&#xD;
&#xD;
      This study will test the practical delivery of the test in terms of time constraints and&#xD;
      error rates. We will also compare the objective performance to the current standard&#xD;
      diagnostic test for COVID-19 and against a proven serological antibody test when a suitable&#xD;
      reference testing becomes available.&#xD;
&#xD;
      We will recruit patients having a SARS CoV-2 PCR swab test and ask for consent to test them&#xD;
      with the PCL antigen test in parallel. We aim to study 200 patients split across three sites;&#xD;
      Musgrove Park Hospital, Basildon University Hospital and Southend University Hospital. The&#xD;
      results will not be used to guide clinical decision making. Patients having a COVID PCR test&#xD;
      will be asked to read the patient information sheet and asked if they would like to&#xD;
      participate. The patients will be asked to have a second nasal/throat swab taken shortly&#xD;
      after their swab for the PCR test.&#xD;
&#xD;
      Written informed consent will be taken for whole blood or plasma left over from any routine&#xD;
      clinical sample to be stored as anonymised samples for future testing once a reference test&#xD;
      becomes available.&#xD;
&#xD;
      We will report results of the onsite clinical diagnostic test and the PCL antigen test with&#xD;
      the number of the kit used, and test date. Anonymised information about year of birth, gender&#xD;
      and place of testing will be collected alongside date of onset, symptoms and immunodeficiency&#xD;
      status or significant conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be identified as they attend assessment areas or testing facilities hosted&#xD;
      by the recruiting NHS centres. They will be screened by clinical staff and identified to the&#xD;
      research team.&#xD;
&#xD;
      Consent will be taken by a clinical staff member or research staff member with the aim of&#xD;
      reducing the number of contacts with the patients and minimising the usage of personal&#xD;
      protective equipment.&#xD;
&#xD;
      The consent form gives the patient the opportunity to ask further questions. Only those that&#xD;
      are able to consent for themselves will be recruited for this trial.&#xD;
&#xD;
      We want to allow patients as long as possible to make a decision to participate but we feel&#xD;
      it is important if possible that the swab samples are taken during the same patient contact&#xD;
      (reducing PPE usage and minimising additional staff exposures). However there should not be&#xD;
      undue delay to clinical testing therefore we propose if due to clinical urgency potential&#xD;
      participants do not have sufficient time to consider the patient information sheet and&#xD;
      discuss the trial prior to the PCR swab being taken they can have up to 24 hours to consider&#xD;
      this information and participate if they wish to.&#xD;
&#xD;
      Consent will be taken by a clinical staff member or research staff member reducing the number&#xD;
      of contacts with the patients. They will then be assigned a trial number used to identify&#xD;
      them during the trial. The consent form that will be photocopied and reprinted on clean&#xD;
      paper, with the original staying with the patient. The clean copy will be stored in the&#xD;
      patient's notes and the case record file.&#xD;
&#xD;
      The current standard COVID PCR swab will be taken and a second swab taken immediately after&#xD;
      for use in the rapid antigen test. As the swab process can be uncomfortable after the first&#xD;
      swab is taken for the standard clinical test (PCR) the participant's consent will be&#xD;
      confirmed again prior to taking the second swab required for the antigen test. After consent&#xD;
      the research team will complete an anonymised data case record form from the notes and&#xD;
      clinical management database. Participant's year of birth and date of onset of symptoms if&#xD;
      symptomatic will be documented.&#xD;
&#xD;
      From routine blood samples taken by phlebotomy or clinical staff consent will be sort to&#xD;
      store a leftover sample. This will be processed and stored by research laboratory staff. This&#xD;
      will be stored in an anonymised secure research freezer.&#xD;
&#xD;
      In the laboratory their swab for the PCL COVID19 Ag rapid FIA will be run on the test&#xD;
      platform. Following the test the swab will be destroyed as per local guidelines for&#xD;
      contaminated items. This will performed by dedicated research laboratory scientists.&#xD;
      Participant's results from this antigen test will not be used to make clinical decisions. We&#xD;
      will not be able to feedback participants' individual results.&#xD;
&#xD;
      Participants are expected to be in the study for total of 20 minutes total although this will&#xD;
      be spread over their patient journey so they have sufficient time to read the information&#xD;
      leaflet and ask questions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">June 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>Evaluation of diagnostic test - point of care</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To compare the result of SARS-COV2 PCR test to PCL rapid antigen test</measure>
    <time_frame>within 24 hours</time_frame>
    <description>Compare the sensitivity and specificity of the rapid antigen testing to current PCR test and any future developed reference test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of technically failed samples due to test issues.</measure>
    <time_frame>At time of testing (within 30 minutes)</time_frame>
    <description>Number of PCL antigen tests that are invalid (no control testing line)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time taken for PCL Antigen test result</measure>
    <time_frame>within 30 minutes</time_frame>
    <description>Time from swab being taken to result being read by point of care analyser, manufacturer anticipates 10-15 minutes</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>COVID</condition>
  <condition>SARS-CoV 2</condition>
  <arm_group>
    <arm_group_label>PCL Rapid Antigen Test arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm trial design. Only patients undergoing standard clinical testing (SARS-CoV-2 PCR test) and consenting for additional testing with the PCL rapid antigen test will be included</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test)</intervention_name>
    <description>The PCL COV05 - COVID 19 Ag Rapid FIA test has FSC and CE approvals for the qualitative detection of SARS-CoV-2 Antigens from human oropharyngeal swabs and deep sputum samples. The manufacturer is PCL Corporation Ltd 17F, 128 B-dong, Courthouse-ro, Songpa-gu, Seoul, South Korea.</description>
    <arm_group_label>PCL Rapid Antigen Test arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant has clinical indication for a COVID diagnostic test and a clinical blood&#xD;
             sample from which whole blood or plasma will be leftover for storage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Musgrove Park Hospital</name>
      <address>
        <city>Taunton</city>
        <state>Somerset</state>
        <zip>TA1 5DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Justin Pepperell, MD</last_name>
      <email>justin.pepperell@tst.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Caitlin Morgan, MBBS</last_name>
      <email>caitlin.morgan@tst.nhs.uk</email>
    </contact_backup>
    <investigator>
      <last_name>Caitlin Morgan, MBBS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Justin Pepperell, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anitgen testing</keyword>
  <keyword>Coronavirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>anonymised individual data would be available to be shared on request from other research teams/public health bodies but no formal plans in place at time of submission</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>on study completion and for 5 years after</ipd_time_frame>
    <ipd_access_criteria>other clinical researchers or public health bodies evaluating diagnostic tests for COVID-19</ipd_access_criteria>
  </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/NCT04403906
org study id: IRAS283137
nct id: NCT04403906
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the utility of the PCL Rapid Antigen Test for Coronavirus
      (COVID-19) in a real world clinical setting. The PCL test has completed laboratory validation
      and holds a European CE marking for in vitro diagnostic devices. These tests have been made
      available to South West Pathology Services as a donation in kind by iPP (Integrated Pathology
      Partnership). They have been widely used in South Korea.

      This study will test the practical delivery of the test in terms of time constraints and
      error rates. We will also compare the objective performance to the current standard
      diagnostic test for COVID-19 and against a proven serological antibody test when a suitable
      reference testing becomes available.

      We will recruit patients having a SARS CoV-2 PCR swab test and ask for consent to test them
      with the PCL antigen test in parallel. We aim to study 200 patients split across three sites;
      Musgrove Park Hospital, Basildon University Hospital and Southend University Hospital. The
      results will not be used to guide clinical decision making. Patients having a COVID PCR test
      will be asked to read the patient information sheet and asked if they would like to
      participate. The patients will be asked to have a second nasal/throat swab taken shortly
      after their swab for the PCR test.

      Written informed consent will be taken for whole blood or plasma left over from any routine
      clinical sample to be stored as anonymised samples for future testing once a reference test
      becomes available.

      We will report results of the onsite clinical diagnostic test and the PCL antigen test with
      the number of the kit used, and test date. Anonymised information about year of birth, gender
      and place of testing will be collected alongside date of onset, symptoms and immunodeficiency
      status or significant conditions.
Participants will be identified as they attend assessment areas or testing facilities hosted
      by the recruiting NHS centres. They will be screened by clinical staff and identified to the
      research team.

      Consent will be taken by a clinical staff member or research staff member with the aim of
      reducing the number of contacts with the patients and minimising the usage of personal
      protective equipment.

      The consent form gives the patient the opportunity to ask further questions. Only those that
      are able to consent for themselves will be recruited for this trial.

      We want to allow patients as long as possible to make a decision to participate but we feel
      it is important if possible that the swab samples are taken during the same patient contact
      (reducing PPE usage and minimising additional staff exposures). However there should not be
      undue delay to clinical testing therefore we propose if due to clinical urgency potential
      participants do not have sufficient time to consider the patient information sheet and
      discuss the trial prior to the PCR swab being taken they can have up to 24 hours to consider
      this information and participate if they wish to.

      Consent will be taken by a clinical staff member or research staff member reducing the number
      of contacts with the patients. They will then be assigned a trial number used to identify
      them during the trial. The consent form that will be photocopied and reprinted on clean
      paper, with the original staying with the patient. The clean copy will be stored in the
      patient's notes and the case record file.

      The current standard COVID PCR swab will be taken and a second swab taken immediately after
      for use in the rapid antigen test. As the swab process can be uncomfortable after the first
      swab is taken for the standard clinical test (PCR) the participant's consent will be
      confirmed again prior to taking the second swab required for the antigen test. After consent
      the research team will complete an anonymised data case record form from the notes and
      clinical management database. Participant's year of birth and date of onset of symptoms if
      symptomatic will be documented.

      From routine blood samples taken by phlebotomy or clinical staff consent will be sort to
      store a leftover sample. This will be processed and stored by research laboratory staff. This
      will be stored in an anonymised secure research freezer.

      In the laboratory their swab for the PCL COVID19 Ag rapid FIA will be run on the test
      platform. Following the test the swab will be destroyed as per local guidelines for
      contaminated items. This will performed by dedicated research laboratory scientists.
      Participant's results from this antigen test will not be used to make clinical decisions. We
      will not be able to feedback participants' individual results.

      Participants are expected to be in the study for total of 20 minutes total although this will
      be spread over their patient journey so they have sufficient time to read the information
      leaflet and ask questions.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Evaluation of diagnostic test - point of care
primary purpose: Diagnostic
masking: None (Open Label)
measure: To compare the result of SARS-COV2 PCR test to PCL rapid antigen test
time frame: within 24 hours
description: Compare the sensitivity and specificity of the rapid antigen testing to current PCR test and any future developed reference test
measure: Number of technically failed samples due to test issues.
time frame: At time of testing (within 30 minutes)
description: Number of PCL antigen tests that are invalid (no control testing line)
measure: Time taken for PCL Antigen test result
time frame: within 30 minutes
description: Time from swab being taken to result being read by point of care analyser, manufacturer anticipates 10-15 minutes
arm group label: PCL Rapid Antigen Test arm
arm group type: Experimental
description: Single arm trial design. Only patients undergoing standard clinical testing (SARS-CoV-2 PCR test) and consenting for additional testing with the PCL rapid antigen test will be included
intervention type: Diagnostic Test
intervention name: PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test)
description: The PCL COV05 - COVID 19 Ag Rapid FIA test has FSC and CE approvals for the qualitative detection of SARS-CoV-2 Antigens from human oropharyngeal swabs and deep sputum samples. The manufacturer is PCL Corporation Ltd 17F, 128 B-dong, Courthouse-ro, Songpa-gu, Seoul, South Korea.
arm group label: PCL Rapid Antigen Test arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Coronavirus Infections
sharing ipd: Yes
ipd description: anonymised individual data would be available to be shared on request from other research teams/public health bodies but no formal plans in place at time of submission
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: on study completion and for 5 years after
ipd access criteria: other clinical researchers or public health bodies evaluating diagnostic tests for COVID-19