<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/NCT04408170</url>
  </required_header>
  <id_info>
    <org_study_id>B00944</org_study_id>
    <nct_id>NCT04408170</nct_id>
  </id_info>
  <brief_title>Facilitating AcceLerated Clinical Validation Of Novel Diagnostics for COVID-19 (FALCON-C19)</brief_title>
  <acronym>FALCON-C19</acronym>
  <official_title>Facilitating AcceLerated Clinical Validation Of Novel Diagnostics for COVID-19 (FALCON-C19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Manchester University 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>
      The United Kingdom and wider world is in the midst of the 2019 novel coronavirus (SARS-CoV-2)&#xD;
      pandemic. Accurate diagnosis of infection, identification of immunity and monitoring the&#xD;
      clinical progression of infection are of paramount importance to our response. Widespread&#xD;
      population testing has proven difficult in western countries and has been limited by test&#xD;
      availability, human resources and long turnaround times (up to 72 hours). This has limited&#xD;
      our ability to control the spread of infection and to develop effective clinical pathways to&#xD;
      enable early social isolation of infected patients and early treatment for those most at&#xD;
      risk. The life sciences industry has responded to the pandemic by developing multiple new in&#xD;
      vitro diagnostic tests (IVDs). To leverage the potential clinical benefit of those tests we&#xD;
      require efficient but robust clinical evaluation. Therefore, to optimise resource utilisation&#xD;
      in this global pandemic, we will conduct a platform adaptive diagnostic study on a national&#xD;
      level, utilising a national network of expertise in the evaluation of diagnostic technology.&#xD;
      This study will enable the evaluation of multiple assays in three priority areas:&#xD;
&#xD;
        1. Evaluation of the diagnostic accuracy of IVDs for active infection with SARS-CoV-2&#xD;
&#xD;
        2. Evaluation of assays monitoring the immune response to SARS-CoV-2 infection&#xD;
&#xD;
        3. Evaluation of the prognostic value of commercially available tests for predicting&#xD;
           prognosis in patients with suspected or confirmed SARS-CoV-2 infection. (This arm will&#xD;
           not be active immediately but may be activated after initiation).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 19, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2023</completion_date>
  <primary_completion_date type="Actual">January 26, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>If the participant has an active SARS-CoV-2 infection during admission</measure>
    <time_frame>Baseline</time_frame>
    <description>This will be determined using the point-of-care test and the laboratory test results</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The participant has had a past SARS-CoV-2 infection</measure>
    <time_frame>Day 90</time_frame>
    <description>This will be determined using the point-of-cacre test for SARS-CoV-2 antibodies and the laboratory test results</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Coronavirus Infection</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Work Stream A</arm_group_label>
    <description>Patients that are recruited in hospital with either query COVID-19 or who have tested positive for COVID-19.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Work Stream B</arm_group_label>
    <description>Known COVID-positive and/or COVID-negative community testing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Work Stream C</arm_group_label>
    <description>Undifferentiated community testing</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Point-of-care test for SARS-CoV-2</intervention_name>
    <description>Throat and nose swabs and/or saliva samples and/or whole blood and/or finger stick samples may be taken to be tested on Point-of-care tests for SARS-CoV-2</description>
    <arm_group_label>Work Stream A</arm_group_label>
    <arm_group_label>Work Stream B</arm_group_label>
    <arm_group_label>Work Stream C</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Throat and nose swabs and/or saliva samples may be taken at multiple time points and stored&#xD;
      for future testing.&#xD;
&#xD;
      Whole blood samples may be taken at multiple time points during the study. Samples will be&#xD;
      processed and the serum stored.&#xD;
&#xD;
      Finger stick samples may also be taken and stored for future testing.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Work Stream A: Patients who present or are referred to secondary/tertiary care settings due&#xD;
        to possible SARS-CoV-2 infection&#xD;
&#xD;
        Work Stream B: Known COVID-positive and/or COVID-negative community testing&#xD;
&#xD;
        Work Stream C: Undifferentiated community testing&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Work Stream A (in-hospital; Group 1 and Group 2):&#xD;
&#xD;
        Group 1 Inclusion Criteria:&#xD;
&#xD;
        We will include participants (patients or staff):&#xD;
&#xD;
          1. That are 18 years or older&#xD;
&#xD;
          2. That will require testing for COVID-19 in the opinion of the treating clinician&#xD;
&#xD;
          3. That may have presented with acute symptoms of COVID-19 (e.g. fever, cough, dyspnoea,&#xD;
             anosmia) or chest x-ray changes or they may be asymptomatic but require testing for&#xD;
             other reasons&#xD;
&#xD;
        Group 2 Inclusion Criteria:&#xD;
&#xD;
        We will include participants:&#xD;
&#xD;
          1. That are 18 years or older&#xD;
&#xD;
          2. That have been admitted for another reason other than suspected SARS-CoV-2 infection,&#xD;
             but when routinely swabbed they have been identified as positive for SARS-CoV-2 PCR&#xD;
&#xD;
        Work Stream B (Group 3):&#xD;
&#xD;
        We will include participants:&#xD;
&#xD;
          1. That are 18 years or older&#xD;
&#xD;
             EITHER:&#xD;
&#xD;
          2. They have been identified as positive for SARS-CoV-2 PCR through testing at national&#xD;
             laboratory infrastructure OR&#xD;
&#xD;
          3. They have been identified as negative for SARS-CoV-2 PCR through testing at national&#xD;
             laboratory infrastructure&#xD;
&#xD;
        Work Stream C (Group 4):&#xD;
&#xD;
        We will include participants:&#xD;
&#xD;
          1. That are 18 years or older&#xD;
&#xD;
          2. Who are undergoing testing for COVID-19, whether they are symptomatic or symptomatic&#xD;
             for COVID-19&#xD;
&#xD;
        Exclusion Criteria for all Work Streams:&#xD;
&#xD;
          1. Patients where it is impossible/unsafe to obtain the required research samples&#xD;
&#xD;
          2. Prisoners&#xD;
&#xD;
          3. Patients where sampling is not feasible&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Richard Body</last_name>
    <role>Study Director</role>
    <affiliation>Manchester University NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sandwell General Hospital Birmingham NHS Trust</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Derby and Burton NHS FT</name>
      <address>
        <city>Derby</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frimley Health NHS FT</name>
      <address>
        <city>Frimley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Airedale NHS FT</name>
      <address>
        <city>Keighley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds Teaching Hospital NHS FT</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's University Hospitals NHS FT</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manchester University NHS FT</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle upon Tyne Hospitals NHS FT</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS FT</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Berkshire Hospital NHS FT</name>
      <address>
        <city>Reading</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barking, Havering &amp; Redbridge Hospitals NHS FT</name>
      <address>
        <city>Romford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salford Royal NHS FT</name>
      <address>
        <city>Salford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton NHS FT</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of North Midlands NHS Trust</name>
      <address>
        <city>Stoke-on-Trent</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>July 27, 2023</last_update_submitted>
  <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>In vitro diagnostics</keyword>
  <keyword>Point-of-care testing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</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/NCT04408170
org study id: B00944
nct id: NCT04408170
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The United Kingdom and wider world is in the midst of the 2019 novel coronavirus (SARS-CoV-2)
      pandemic. Accurate diagnosis of infection, identification of immunity and monitoring the
      clinical progression of infection are of paramount importance to our response. Widespread
      population testing has proven difficult in western countries and has been limited by test
      availability, human resources and long turnaround times (up to 72 hours). This has limited
      our ability to control the spread of infection and to develop effective clinical pathways to
      enable early social isolation of infected patients and early treatment for those most at
      risk. The life sciences industry has responded to the pandemic by developing multiple new in
      vitro diagnostic tests (IVDs). To leverage the potential clinical benefit of those tests we
      require efficient but robust clinical evaluation. Therefore, to optimise resource utilisation
      in this global pandemic, we will conduct a platform adaptive diagnostic study on a national
      level, utilising a national network of expertise in the evaluation of diagnostic technology.
      This study will enable the evaluation of multiple assays in three priority areas:

        1. Evaluation of the diagnostic accuracy of IVDs for active infection with SARS-CoV-2

        2. Evaluation of assays monitoring the immune response to SARS-CoV-2 infection

        3. Evaluation of the prognostic value of commercially available tests for predicting
           prognosis in patients with suspected or confirmed SARS-CoV-2 infection. (This arm will
           not be active immediately but may be activated after initiation).
observational model: Cohort
time perspective: Prospective
measure: If the participant has an active SARS-CoV-2 infection during admission
time frame: Baseline
description: This will be determined using the point-of-care test and the laboratory test results
measure: The participant has had a past SARS-CoV-2 infection
time frame: Day 90
description: This will be determined using the point-of-cacre test for SARS-CoV-2 antibodies and the laboratory test results
arm group label: Work Stream A
description: Patients that are recruited in hospital with either query COVID-19 or who have tested positive for COVID-19.
arm group label: Work Stream B
description: Known COVID-positive and/or COVID-negative community testing
arm group label: Work Stream C
description: Undifferentiated community testing
intervention type: Diagnostic Test
intervention name: Point-of-care test for SARS-CoV-2
description: Throat and nose swabs and/or saliva samples and/or whole blood and/or finger stick samples may be taken to be tested on Point-of-care tests for SARS-CoV-2
arm group label: Work Stream A
arm group label: Work Stream B
arm group label: Work Stream C
Throat and nose swabs and/or saliva samples may be taken at multiple time points and stored
      for future testing.

      Whole blood samples may be taken at multiple time points during the study. Samples will be
      processed and the serum stored.

      Finger stick samples may also be taken and stored for future testing.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
last name: Richard Body
role: Study Director
affiliation: Manchester University NHS Foundation Trust
facility: 
facility: 
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country: United Kingdom
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: No