<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/NCT04473248</url>
  </required_header>
  <id_info>
    <org_study_id>VNV-00552</org_study_id>
    <nct_id>NCT04473248</nct_id>
  </id_info>
  <brief_title>Spartan COVID-19 System: Evaluation of Clinical Sample Collection</brief_title>
  <official_title>Evaluation of Clinical Sample Collection Project: Spartan COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spartan Bioscience Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Humber River Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Ottawa Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Spartan Bioscience 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>
      This study will evaluate the efficacy of various sample collection methods for use with the&#xD;
      Spartan COVID-19 System. It will compare the results from the Spartan COVID-19 System with&#xD;
      results that are obtained using a predicate lab-based COVID-19 test that uses a&#xD;
      nasopharyngeal swab sample. The goal is to determine which sample collection methods are most&#xD;
      effective in capturing SARS-CoV-2 virus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Once the subject is recruited,two nasopharyngeal swabs using the standard method will be&#xD;
      taken from the patient. Additionally, two nasal swab samples will be taken using the Spartan&#xD;
      COVID-19 swabs with an adjusted tip. All samples will be analyzed using the Spartan COVID-19&#xD;
      System.&#xD;
&#xD;
      The lab-based predicate test will be taken at the same time, with results reported back to&#xD;
      Spartan to be compared with results obtained from the Spartan COVID-19 System.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2020</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">August 30, 2020</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>Single Group Assignment</intervention_model>
    <intervention_model_description>Each Patient enrolle dint he study will experience the same modes of sample collection and sample analysis.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The results of the Spartan COVID-19 System tests will not be shared with the participant or the lab, but the lab results will be shared with Spartan once analysis of the Spartan System samples is complete.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Asses the % agreement between predicate results and Spartan COVID-19 results.</measure>
    <time_frame>Through study completion; anticipated to be less than 6 months.</time_frame>
    <description>The purpose of this study is to evaluate which method has the best % agreement between the lab-based predicate results and Spartan COVID-19 System results.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Method 1- Nasopharyngeal Swab in transfer liquid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Method 2- Dipping of specialized swab in VTM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A nasopharyngeal swab will inoculate VTM solution. A modified traditional Spartan Swab will be dipped into the inoculated VTM solution and then transferred to the Spartan COVID-19 System for analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Method 3: Direct input of VTM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Method 4: Collection of nasal sample.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using a modified tip of the Spartan swab, a nasal sample will be taken from the patient and directly placed into the Spartan COVID-19 System for analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spartan COVID-19 System</intervention_name>
    <description>PCR analysis of patient samples using the Spartan COVID-19 System</description>
    <arm_group_label>Method 1- Nasopharyngeal Swab in transfer liquid</arm_group_label>
    <arm_group_label>Method 2- Dipping of specialized swab in VTM</arm_group_label>
    <arm_group_label>Method 3: Direct input of VTM</arm_group_label>
    <arm_group_label>Method 4: Collection of nasal sample.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must have tested positive for COVID-19 via the existing nucleic acid testing method.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Tara Linseman, MSc</last_name>
    <role>Study Director</role>
    <affiliation>Spartan Bioscience Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Humber River Hospital</name>
      <address>
        <city>North York</city>
        <state>Ontario</state>
        <zip>M3M 0B2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Univeristy of Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>November 11, 2020</last_update_submitted>
  <last_update_submitted_qc>November 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</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>COVID-19</mesh_term>
  </condition_browse>
  <!-- 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/NCT04473248
org study id: VNV-00552
nct id: NCT04473248
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the efficacy of various sample collection methods for use with the
      Spartan COVID-19 System. It will compare the results from the Spartan COVID-19 System with
      results that are obtained using a predicate lab-based COVID-19 test that uses a
      nasopharyngeal swab sample. The goal is to determine which sample collection methods are most
      effective in capturing SARS-CoV-2 virus.
Once the subject is recruited,two nasopharyngeal swabs using the standard method will be
      taken from the patient. Additionally, two nasal swab samples will be taken using the Spartan
      COVID-19 swabs with an adjusted tip. All samples will be analyzed using the Spartan COVID-19
      System.

      The lab-based predicate test will be taken at the same time, with results reported back to
      Spartan to be compared with results obtained from the Spartan COVID-19 System.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Each Patient enrolle dint he study will experience the same modes of sample collection and sample analysis.
primary purpose: Diagnostic
masking: Single (Participant)
masking description: The results of the Spartan COVID-19 System tests will not be shared with the participant or the lab, but the lab results will be shared with Spartan once analysis of the Spartan System samples is complete.
measure: Asses the % agreement between predicate results and Spartan COVID-19 results.
time frame: Through study completion; anticipated to be less than 6 months.
description: The purpose of this study is to evaluate which method has the best % agreement between the lab-based predicate results and Spartan COVID-19 System results.
arm group label: Method 1- Nasopharyngeal Swab in transfer liquid
arm group type: Experimental
description: A nasopharyngeal swab will inoculate a proprietary solution which will be transferred to the Spartan COVID-19 System for analysis
arm group label: Method 2- Dipping of specialized swab in VTM
arm group type: Experimental
description: A nasopharyngeal swab will inoculate VTM solution. A modified traditional Spartan Swab will be dipped into the inoculated VTM solution and then transferred to the Spartan COVID-19 System for analysis.
arm group label: Method 3: Direct input of VTM
arm group type: Experimental
description: Using the VTM from Method 2, pipette 10uL of VTM, inoculated with sample, into the Spartan COVID-19 System for analysis.
arm group label: Method 4: Collection of nasal sample.
arm group type: Experimental
description: Using a modified tip of the Spartan swab, a nasal sample will be taken from the patient and directly placed into the Spartan COVID-19 System for analysis.
intervention type: Device
intervention name: Spartan COVID-19 System
description: PCR analysis of patient samples using the Spartan COVID-19 System
arm group label: Method 1- Nasopharyngeal Swab in transfer liquid
arm group label: Method 2- Dipping of specialized swab in VTM
arm group label: Method 3: Direct input of VTM
arm group label: Method 4: Collection of nasal sample.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tara Linseman, MSc
role: Study Director
affiliation: Spartan Bioscience Inc.
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: COVID-19