<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/NCT04460690</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0855</org_study_id>
    <secondary_id>A536300</secondary_id>
    <secondary_id>SMPH/PATHOL-LAB MED/ANAT PATH</secondary_id>
    <secondary_id>Protocol Version 8/30/2020</secondary_id>
    <secondary_id>5P51OD011106-59</secondary_id>
    <nct_id>NCT04460690</nct_id>
  </id_info>
  <brief_title>Rapid, Onsite COVID-19 Detection</brief_title>
  <official_title>Rapid, Onsite COVID-19 Detection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>AIDS Vaccine Research Lab</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to evaluate and improve a rapid COVID-19 test. The test&#xD;
      is designed to identify people who are most contagious and likely to spread the virus to&#xD;
      others. This test will be performed at various locations in the Madison area using a mobile&#xD;
      laboratory or standard lab space for processing. Saliva samples can be collected and&#xD;
      processed at these locations or participants can self-collect at home and drop their samples&#xD;
      off at designated locations for same day processing. Results of potential findings of&#xD;
      clinical significance will be communicated to the participants by a physician with&#xD;
      appropriate expertise on the study team. Individuals with a potential finding of clinical&#xD;
      significance will be encouraged to self-isolate and obtain a diagnostic test at their&#xD;
      earliest convenience. No results will be given if the test is negative. If the participant&#xD;
      consents, advanced molecular testing such as PCR or viral sequencing can be done and results&#xD;
      can be shared via online databases, presentations and publications along with the date, site&#xD;
      and county of collection to help facilitate tracking the spread of the virus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Virtually all COVID-19 RNA assays require centralized laboratories. Samples collected in&#xD;
      locations including public testing sites, workplaces, nursing homes, and residential housing&#xD;
      are transported to centralized laboratories for testing, leading to lengthy delays in results&#xD;
      reporting. The window of maximal contagiousness is thought to be only a few days, so these&#xD;
      delays create the risk of excess transmission. Current testing methods are painful, which&#xD;
      encourages testing hesitancy. Rapid, onsite detection of SARS-CoV-2 RNA from non-invasive&#xD;
      saliva could overcome these issues and provide a pathway to high-throughput detection of&#xD;
      people at the greatest risk of SARS-CoV-2 transmission but the logistics of such a testing&#xD;
      program require real-world prototyping.&#xD;
&#xD;
      The investigators have developed a simple test to detect high concentrations of SARS-CoV-2 in&#xD;
      saliva with assays that require no specialized equipment and can be completed in one hour.&#xD;
      This assay is not diagnostic for SARS-CoV-2; instead, it specifically identifies saliva&#xD;
      samples that have high amounts of viral RNA that are correlated with live virus shedding.&#xD;
      Many samples that would be identified as SARS-CoV-2 by diagnostic qRT-PCR would be negative&#xD;
      with this saliva assay. Conversely, detection of RNA in saliva is a potential finding of&#xD;
      clinical significance, so participants with that result will be contacted by a medical&#xD;
      professional to discuss potential follow-up with their own health care provider, including a&#xD;
      possible independent diagnostic testing.&#xD;
&#xD;
      Because the assay requires no specialized equipment, it can be performed at the site of&#xD;
      sample collection using a portable laboratory that fits in the backseat of a car. The&#xD;
      prototype testing will take place in a variety of settings that may include parking lots,&#xD;
      workplaces, nursing homes and residential housing. Participants will be asked to consent to&#xD;
      provide a saliva sample that will be tested for SARS-CoV-2 RNA levels consistent with live&#xD;
      virus shedding. The consent document will explicitly state that this is not a diagnostic test&#xD;
      for SARS-CoV-2 but that a potential finding of clinical significance should be discussed with&#xD;
      a medical professional. Participants can opt-out of receiving any results at the time of&#xD;
      consent and can provide samples for the sole purpose of contributing to community&#xD;
      surveillance and assay development. Paper consent forms will be reviewed and signed and held&#xD;
      by team members in a secure location (locked box at the collection site) until taken back to&#xD;
      the AIDS Vaccine Research Laboratory for storage. Participants will then spit into a coded&#xD;
      vessel (e.g., cup or tube). Samples should be at least 1ml (~¼ teaspoon) and will be assayed&#xD;
      for the presence of SARS-CoV-2 RNA using the aforementioned detection assay; the presence of&#xD;
      high concentrations of SARS-CoV-2 RNA is indicated by a colorimetric change from pink to&#xD;
      yellow/orange.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Samples Tested</measure>
    <time_frame>15 minutes</time_frame>
    <description>samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety: Number of Participants Who Tested Positive for COVID-19</measure>
    <time_frame>up to 2 months</time_frame>
    <description>Feasibility is determined when at least 10000 samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory. This testing protocol will be considered safe if COVID-19 rates of those performing the tests do not significantly exceed those of the communities in which the tests are being performed.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>COVID-19</condition>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>Rapid Onsite COVID-29 Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rapid Onsite COVID-19 Detection</intervention_name>
    <description>saliva assay test for high concentrations of SARS-CoV-2</description>
    <arm_group_label>Rapid Onsite COVID-29 Testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing to provide informed consent&#xD;
&#xD;
          -  Willing to provide informed consent and spit into a vessel&#xD;
&#xD;
          -  Individuals at least 5 years of age and have a parent or legal guardian present to&#xD;
             consent if under 18 years&#xD;
&#xD;
          -  Adult participants must have decision-making capacity to provide consent on their own&#xD;
             behalf.&#xD;
&#xD;
          -  Participants must be able to speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age with no parent or legal guardian present or under the age of 5&#xD;
             yrs&#xD;
&#xD;
          -  Participants must not have visual or hearing impairments, or low literacy, that would&#xD;
             prevent them from reading the consent form and interacting with a member of the&#xD;
             research team to ask questions and receive responses during the consent process&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David O'Connor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://dho.pathology.wisc.edu/</url>
    <description>Dave O'Connor's Lab</description>
  </link>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <results_first_submitted>December 23, 2021</results_first_submitted>
  <results_first_submitted_qc>January 14, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 19, 2022</results_first_posted>
  <last_update_submitted>January 18, 2022</last_update_submitted>
  <last_update_submitted_qc>January 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rapid detection</keyword>
  <keyword>assay</keyword>
  <keyword>saliva</keyword>
  <keyword>coronavirus</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>Yes</sharing_ipd>
    <ipd_description>Participants will consent to having their data (not their name) and viral sequences shared with the public via manuscripts, presentations and online databases; the study team will share that with other researchers when needed. Samples can be shared with UW researchers internally and non UW researchers through the Material Transfer Agreement process.</ipd_description>
    <ipd_time_frame>Data from this study may be requested from other researchers 7 years after the completion of the primary endpoint by contacting David O'Connor at the University of Wisconsin - Madison.</ipd_time_frame>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT04460690/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT04460690/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Rapid Onsite COVID-29 Testing</title>
          <description>Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.&#xD;
Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Community Participants</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Investigator Participants</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Rapid Onsite COVID-29 Testing - Investigators</title>
          <description>Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.&#xD;
Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2</description>
        </group>
        <group group_id="B2">
          <title>Rapid Onsite COVID-29 Testing - Participants</title>
          <description>Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.&#xD;
Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="83"/>
            <count group_id="B3" value="93"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <population>Participant age was not collected.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <population>Participant gender was not collected.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>any gender</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="83"/>
                    <count group_id="B3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Samples Tested</title>
        <description>samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory.</description>
        <time_frame>15 minutes</time_frame>
        <population>3692 samples were collected from 93 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Rapid Onsite COVID-29 Testing</title>
            <description>Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.&#xD;
Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Samples Tested</title>
          <description>samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory.</description>
          <population>3692 samples were collected from 93 participants.</population>
          <units>samples</units>
          <param>Count of Units</param>
          <units_analyzed>samples</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>samples</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3692"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3692"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Safety: Number of Participants Who Tested Positive for COVID-19</title>
        <description>Feasibility is determined when at least 10000 samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory. This testing protocol will be considered safe if COVID-19 rates of those performing the tests do not significantly exceed those of the communities in which the tests are being performed.</description>
        <time_frame>up to 2 months</time_frame>
        <population>The participants included people from the community and team members performing the tests.</population>
        <group_list>
          <group group_id="O1">
            <title>Community Participants</title>
            <description>Community participants that gave samples</description>
          </group>
          <group group_id="O2">
            <title>Investigator Participants</title>
            <description>The team members that participated in the testing</description>
          </group>
        </group_list>
        <measure>
          <title>Safety: Number of Participants Who Tested Positive for COVID-19</title>
          <description>Feasibility is determined when at least 10000 samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory. This testing protocol will be considered safe if COVID-19 rates of those performing the tests do not significantly exceed those of the communities in which the tests are being performed.</description>
          <population>The participants included people from the community and team members performing the tests.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were not monitored for adverse events during sample collection.</time_frame>
      <desc>Participants were able to donate a saliva sample using two different methods. The first being a drop box with no interaction with the study team (saliva samples were collected off site) and the second being an in person saliva sample collection at designate dates and times. Participants were not monitored for adverse events during sample collection.</desc>
      <group_list>
        <group group_id="E1">
          <title>Rapid Onsite COVID-29 Testing - Community Participants</title>
          <description>Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.&#xD;
Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2</description>
        </group>
        <group group_id="E2">
          <title>Rapid Onsite COVID-29 Testing - Investigator Participants</title>
          <description>Investigator participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.&#xD;
Rapid Onsite COVID-19 Detection: saliva assay test for high concentrations of SARS-CoV-2</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kristi Hall</name_or_title>
      <organization>University of Wisconsin - Madison</organization>
      <phone>608-890-0844</phone>
      <email>klhall1@wisc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04460690
org study id: 2020-0855
secondary id: A536300
secondary id: SMPH/PATHOL-LAB MED/ANAT PATH
secondary id: Protocol Version 8/30/2020
secondary id: 5P51OD011106-59
nct id: NCT04460690
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this research study is to evaluate and improve a rapid COVID-19 test. The test
      is designed to identify people who are most contagious and likely to spread the virus to
      others. This test will be performed at various locations in the Madison area using a mobile
      laboratory or standard lab space for processing. Saliva samples can be collected and
      processed at these locations or participants can self-collect at home and drop their samples
      off at designated locations for same day processing. Results of potential findings of
      clinical significance will be communicated to the participants by a physician with
      appropriate expertise on the study team. Individuals with a potential finding of clinical
      significance will be encouraged to self-isolate and obtain a diagnostic test at their
      earliest convenience. No results will be given if the test is negative. If the participant
      consents, advanced molecular testing such as PCR or viral sequencing can be done and results
      can be shared via online databases, presentations and publications along with the date, site
      and county of collection to help facilitate tracking the spread of the virus.
Virtually all COVID-19 RNA assays require centralized laboratories. Samples collected in
      locations including public testing sites, workplaces, nursing homes, and residential housing
      are transported to centralized laboratories for testing, leading to lengthy delays in results
      reporting. The window of maximal contagiousness is thought to be only a few days, so these
      delays create the risk of excess transmission. Current testing methods are painful, which
      encourages testing hesitancy. Rapid, onsite detection of SARS-CoV-2 RNA from non-invasive
      saliva could overcome these issues and provide a pathway to high-throughput detection of
      people at the greatest risk of SARS-CoV-2 transmission but the logistics of such a testing
      program require real-world prototyping.

      The investigators have developed a simple test to detect high concentrations of SARS-CoV-2 in
      saliva with assays that require no specialized equipment and can be completed in one hour.
      This assay is not diagnostic for SARS-CoV-2; instead, it specifically identifies saliva
      samples that have high amounts of viral RNA that are correlated with live virus shedding.
      Many samples that would be identified as SARS-CoV-2 by diagnostic qRT-PCR would be negative
      with this saliva assay. Conversely, detection of RNA in saliva is a potential finding of
      clinical significance, so participants with that result will be contacted by a medical
      professional to discuss potential follow-up with their own health care provider, including a
      possible independent diagnostic testing.

      Because the assay requires no specialized equipment, it can be performed at the site of
      sample collection using a portable laboratory that fits in the backseat of a car. The
      prototype testing will take place in a variety of settings that may include parking lots,
      workplaces, nursing homes and residential housing. Participants will be asked to consent to
      provide a saliva sample that will be tested for SARS-CoV-2 RNA levels consistent with live
      virus shedding. The consent document will explicitly state that this is not a diagnostic test
      for SARS-CoV-2 but that a potential finding of clinical significance should be discussed with
      a medical professional. Participants can opt-out of receiving any results at the time of
      consent and can provide samples for the sole purpose of contributing to community
      surveillance and assay development. Paper consent forms will be reviewed and signed and held
      by team members in a secure location (locked box at the collection site) until taken back to
      the AIDS Vaccine Research Laboratory for storage. Participants will then spit into a coded
      vessel (e.g., cup or tube). Samples should be at least 1ml (~¼ teaspoon) and will be assayed
      for the presence of SARS-CoV-2 RNA using the aforementioned detection assay; the presence of
      high concentrations of SARS-CoV-2 RNA is indicated by a colorimetric change from pink to
      yellow/orange.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Samples Tested
time frame: 15 minutes
description: samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory.
measure: Safety: Number of Participants Who Tested Positive for COVID-19
time frame: up to 2 months
description: Feasibility is determined when at least 10000 samples are tested and consistently shown that the assay can detect SARS-CoV-2 safely, consistently and accurately at multiple locations using the mobile laboratory. This testing protocol will be considered safe if COVID-19 rates of those performing the tests do not significantly exceed those of the communities in which the tests are being performed.
arm group label: Rapid Onsite COVID-29 Testing
arm group type: Experimental
description: Community participants provide a saliva sample for a simple test to detect high concentrations of SARS-CoV-2 in saliva with assays that require no specialized equipment and can be completed in one hour.
intervention type: Device
intervention name: Rapid Onsite COVID-19 Detection
description: saliva assay test for high concentrations of SARS-CoV-2
arm group label: Rapid Onsite COVID-29 Testing
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: No
last name: David O'Connor, PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
url: https://dho.pathology.wisc.edu/
description: Dave O'Connor's Lab
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes
ipd description: Participants will consent to having their data (not their name) and viral sequences shared with the public via manuscripts, presentations and online databases; the study team will share that with other researchers when needed. Samples can be shared with UW researchers internally and non UW researchers through the Material Transfer Agreement process.
ipd time frame: Data from this study may be requested from other researchers 7 years after the completion of the primary endpoint by contacting David O'Connor at the University of Wisconsin - Madison.
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 