xml: <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/NCT06008457</url>
    </required_header>
    <id_info>
      <org_study_id>SQNM-VIR-403</org_study_id>
      <nct_id>NCT06008457</nct_id>
    </id_info>
    <brief_title>Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit</brief_title>
    <official_title>Prospective Clinical Evaluation of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as Offered Commercially by Labcorp - A Registry Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sequenom, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Labcorp Corporation of America Holdings, Inc</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Sequenom, Inc.</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>
        To compare the results obtained by analysis of a self-collected anterior nasal (AN) swab as&#xD;
        part of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit to a healthcare provider&#xD;
        (HCP)-collected AN swab in patients with symptoms of viral respiratory infection consistent&#xD;
        with influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV) and/or&#xD;
        SARS-CoV-2 (C-19).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 17, 2023</start_date>
    <completion_date type="Anticipated">May 17, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 17, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>6 Months</target_duration>
    <primary_outcome>
      <measure>Collection method comparison</measure>
      <time_frame>1 day</time_frame>
      <description>To evaluate the concordance between the results of a self-collected AN swab specimen using the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as analyzed by the Labcorp Seasonal Respiratory Virus RT-PCR Test and an HCP-collected AN swab as analyzed by the comparator assays in subjects presenting with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Whole blood specimen collection</measure>
      <time_frame>1 day</time_frame>
      <description>The whole blood specimen collection is designed to support assay research and/or development and validation of blood-based virology assays.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>COVID-19 Respiratory Infection</condition>
    <condition>Influenza A</condition>
    <condition>Influenza Type B</condition>
    <condition>RSV Infection</condition>
    <arm_group>
      <arm_group_label>Self-collection first</arm_group_label>
      <description>Subjects will self-collect an anterior nasal swab first</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HCP-collection first</arm_group_label>
      <description>Subjects will have their healthcare provider collect an anterior nasal swab first</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Labcorp COVID-19+Flu+RSV Test Home Collection Kit</intervention_name>
      <description>The self-collected Labcorp COVID-19+Flu+RSV Test Home Collection Kit results as generated by the commercially available Labcorp Seasonal Respiratory Virus RT-PCR Test will be compared to the HCP-collected results as generated by Labcorp R&amp;D using the comparator assays.</description>
      <arm_group_label>HCP-collection first</arm_group_label>
      <arm_group_label>Self-collection first</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Remnant swab samples from all subjects (positive and negative) and isolated viral DNA will be&#xD;
        maintained for future related research. No human DNA will be maintained.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Male or female patients ≥2 years of age who present to the participating study clinics with&#xD;
          symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19 and&#xD;
          who meet all study inclusion criteria and no exclusion criteria will be considered for&#xD;
          enrollment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  presents with symptoms of viral respiratory infection consistent with Flu A, Flu B,&#xD;
               RSV and/or C-19;&#xD;
  &#xD;
            -  Subject can read and understand written instructions in English; and&#xD;
  &#xD;
            -  Subject is able, in the professional opinion of the investigator, to provide up to&#xD;
               18.5mL of whole blood at the clinic visit. NOTE - the blood draw will be optional for&#xD;
               subjects &lt;12 years of age.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  no personal access to the internet and no email address&#xD;
  &#xD;
            -  Subject is 14-17 years of age and their parent or legal guardian is unable to&#xD;
               supervise the collection of the AN swab sample from the subject;&#xD;
  &#xD;
            -  Subject is &lt;14 years of age and their parent or legal guardian refuses to collect the&#xD;
               AN swab sample from the subject; or&#xD;
  &#xD;
            -  Previous participation in this protocol.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Graham McLennan, MS</last_name>
      <role>Study Director</role>
      <affiliation>Laboratory Corporation of America</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Graham McLennan, MS</last_name>
      <phone>858 202-9162</phone>
      <email>mclenng@labcorp.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Exer Urgent Care</name>
        <address>
          <city>Pasadena</city>
          <state>California</state>
          <zip>91107</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kerry McCabe, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</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>Communicable Diseases</mesh_term>
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Influenza, Human</mesh_term>
      <mesh_term>Respiratory Tract Infections</mesh_term>
      <mesh_term>Respiratory Syncytial Virus Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There are no plans to share data</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008457
  org study id: SQNM-VIR-403
  nct id: NCT06008457
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To compare the results obtained by analysis of a self-collected anterior nasal (AN) swab as
        part of the Labcorp COVID-19+Flu+RSV Test Home Collection Kit to a healthcare provider
        (HCP)-collected AN swab in patients with symptoms of viral respiratory infection consistent
        with influenza A (Flu A), influenza B (Flu B), respiratory syncytial virus (RSV) and/or
        SARS-CoV-2 (C-19).
  observational model: Cohort
  time perspective: Prospective
  measure: Collection method comparison
  time frame: 1 day
  description: To evaluate the concordance between the results of a self-collected AN swab specimen using the Labcorp COVID-19+Flu+RSV Test Home Collection Kit as analyzed by the Labcorp Seasonal Respiratory Virus RT-PCR Test and an HCP-collected AN swab as analyzed by the comparator assays in subjects presenting with symptoms of viral respiratory infection consistent with Flu A, Flu B, RSV and/or C-19.
  measure: Whole blood specimen collection
  time frame: 1 day
  description: The whole blood specimen collection is designed to support assay research and/or development and validation of blood-based virology assays.
  arm group label: Self-collection first
  description: Subjects will self-collect an anterior nasal swab first
  arm group label: HCP-collection first
  description: Subjects will have their healthcare provider collect an anterior nasal swab first
  intervention type: Device
  intervention name: Labcorp COVID-19+Flu+RSV Test Home Collection Kit
  description: The self-collected Labcorp COVID-19+Flu+RSV Test Home Collection Kit results as generated by the commercially available Labcorp Seasonal Respiratory Virus RT-PCR Test will be compared to the HCP-collected results as generated by Labcorp R&D using the comparator assays.
  arm group label: HCP-collection first
  arm group label: Self-collection first
  Remnant swab samples from all subjects (positive and negative) and isolated viral DNA will be
        maintained for future related research. No human DNA will be maintained.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 89 Years
  healthy volunteers: No
  last name: Graham McLennan, MS
  role: Study Director
  affiliation: Laboratory Corporation of America
  last name: Graham McLennan, MS
  phone: 858 202-9162
  email: mclenng@labcorp.com
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: COVID-19
  mesh term: Influenza, Human
  mesh term: Respiratory Tract Infections
  mesh term: Respiratory Syncytial Virus Infections
  sharing ipd: No
  ipd description: There are no plans to share data