<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/NCT04408066</url>
  </required_header>
  <id_info>
    <org_study_id>S-CLIN-PROT-00028</org_study_id>
    <nct_id>NCT04408066</nct_id>
  </id_info>
  <brief_title>COVID-19: A POC Test Under Research &amp; Evaluation</brief_title>
  <acronym>CAPTURE</acronym>
  <official_title>Specimen Collection for Development and Performance Evaluation of the LumiraDx Platform Point of Care Tests for Sars-Cov-2 IgG/IgM &amp; Antigen to be Used as an Aid in Diagnosis of COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LumiraDx UK Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LumiraDx UK Limited</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>
      Collection of nasal/nasopharyngeal/throat swabs and blood samples from patients presenting at&#xD;
      their designated care facility displaying symptoms of COVID-19 and undergoing a SOC&#xD;
      SARS-CoV-2 test or those who have tested positive in the past to aid development, calibration&#xD;
      and performance evaluation for the LumiraDx POC test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CAPTURE is a two-stage sample collection study to complete the development, calibration and&#xD;
      performance evaluation phases of the LumiraDx Point of Care (POC) device for the detection of&#xD;
      the SARS-CoV-2 virus and the SARS-CoV-2 IgG/IgM status of infected patients. The study is&#xD;
      split into two arms targeting separate populations throughout each stage.&#xD;
&#xD;
      Stage 1: Consists of sample collection only, to facilitate the in-house development and&#xD;
      calibration of the LumiraDx SARS-CoV-2 assays.&#xD;
&#xD;
      Stage 2: Consists of sample collection to facilitate the performance evaluation of the&#xD;
      LumiraDx SARS-CoV-2 studies. In this stage the testing will be completed onsite using the&#xD;
      LumiraDx POC device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Number of required participants met&#xD;
  </why_stopped>
  <start_date type="Actual">April 30, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A Sample Collection &amp; Performance Evaluation Study.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance of the LumiraDx Assay versus reference methods with regards to clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.</measure>
    <time_frame>1 Year approx</time_frame>
    <description>Primary Outcome - To collect sufficient SARS-CoV-2 samples (nasal/nasopharyngeal/throat swabs and blood samples) to aid development, calibration and performance evaluation of the LumiraDx POC test. Results will be used to asses performance of the LumiraDx assay versus reference methods with regards to the clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Arm A:Suspected COVID-19 patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm A: Suspected COVID-19 Patients - SARS-CoV-2 viral antigen test swab and blood sample for SARS-CoV-2 IgG/IgM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: Previously positive COVID-19 patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm B: Previously Positive COVID-19 patients - SARS-CoV-2 IgG/IgM blood sample. Capillary fingerstick samples will additionally be collected in Stage 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sample Collection/Performance Evaluation (A)</intervention_name>
    <description>This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention.&#xD;
Sample types include:&#xD;
Nasal/Throat/Nasal Throat Combo/ Nasopharyngeal (as per sites SOC) Swab&#xD;
Whole Venous Blood</description>
    <arm_group_label>Arm A:Suspected COVID-19 patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sample Collection/Performance Evaluation (B)</intervention_name>
    <description>This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention.&#xD;
Sample types include:&#xD;
Whole Venous Blood&#xD;
Fingerstick Capillary Sample</description>
    <arm_group_label>Arm B: Previously positive COVID-19 patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is at least 18 years of age.&#xD;
&#xD;
          2. Patient meets either of the below categories:&#xD;
&#xD;
               1. Patient is presenting with symptoms indicative of COVID-19 and will be completing&#xD;
                  SOC sampling for SARS-CoV-2 PCR testing. (Eligible for Arm A)&#xD;
&#xD;
               2. Patient has had a confirmed positive SARS-CoV-2 PCR test result in the past.&#xD;
                  (Eligible for Arm B)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient does not have the capacity to consent as determined by the Research Team&#xD;
             (and the impartial witness if applicable).&#xD;
&#xD;
          2. The patient is deemed to be unsuitable for research at the research teams' discretion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samer Elkhodair</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College London Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Homerton University Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>E9 6SR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>April 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>POC</keyword>
  <keyword>IVD</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>IgG</keyword>
  <keyword>IgM</keyword>
  <keyword>Antigen</keyword>
  <keyword>Antibody</keyword>
  <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>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/NCT04408066
org study id: S-CLIN-PROT-00028
nct id: NCT04408066
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Collection of nasal/nasopharyngeal/throat swabs and blood samples from patients presenting at
      their designated care facility displaying symptoms of COVID-19 and undergoing a SOC
      SARS-CoV-2 test or those who have tested positive in the past to aid development, calibration
      and performance evaluation for the LumiraDx POC test.
CAPTURE is a two-stage sample collection study to complete the development, calibration and
      performance evaluation phases of the LumiraDx Point of Care (POC) device for the detection of
      the SARS-CoV-2 virus and the SARS-CoV-2 IgG/IgM status of infected patients. The study is
      split into two arms targeting separate populations throughout each stage.

      Stage 1: Consists of sample collection only, to facilitate the in-house development and
      calibration of the LumiraDx SARS-CoV-2 assays.

      Stage 2: Consists of sample collection to facilitate the performance evaluation of the
      LumiraDx SARS-CoV-2 studies. In this stage the testing will be completed onsite using the
      LumiraDx POC device.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: A Sample Collection & Performance Evaluation Study.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Performance of the LumiraDx Assay versus reference methods with regards to clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.
time frame: 1 Year approx
description: Primary Outcome - To collect sufficient SARS-CoV-2 samples (nasal/nasopharyngeal/throat swabs and blood samples) to aid development, calibration and performance evaluation of the LumiraDx POC test. Results will be used to asses performance of the LumiraDx assay versus reference methods with regards to the clinical sensitivity and specificity for the detection of the SARS-COV-2 IgG/IgM and viral antigen in patient samples.
arm group label: Arm A:Suspected COVID-19 patients
arm group type: Experimental
description: Arm A: Suspected COVID-19 Patients - SARS-CoV-2 viral antigen test swab and blood sample for SARS-CoV-2 IgG/IgM
arm group label: Arm B: Previously positive COVID-19 patients
arm group type: Experimental
description: Arm B: Previously Positive COVID-19 patients - SARS-CoV-2 IgG/IgM blood sample. Capillary fingerstick samples will additionally be collected in Stage 2.
intervention type: Diagnostic Test
intervention name: Sample Collection/Performance Evaluation (A)
description: This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention.
Sample types include:
Nasal/Throat/Nasal Throat Combo/ Nasopharyngeal (as per sites SOC) Swab
Whole Venous Blood
arm group label: Arm A:Suspected COVID-19 patients
intervention type: Diagnostic Test
intervention name: Sample Collection/Performance Evaluation (B)
description: This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention.
Sample types include:
Whole Venous Blood
Fingerstick Capillary Sample
arm group label: Arm B: Previously positive COVID-19 patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samer Elkhodair
role: Principal Investigator
affiliation: University College London Hospitals
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No