<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/NCT04424446</url>
  </required_header>
  <id_info>
    <org_study_id>200128</org_study_id>
    <secondary_id>20-CC-0128</secondary_id>
    <nct_id>NCT04424446</nct_id>
  </id_info>
  <brief_title>Saliva as Source of Detection for SARS-CoV-2</brief_title>
  <official_title>Evaluation of Saliva as Source of Detection for SARS-CoV-2</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institutes of Health Clinical Center (CC)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Nasopharyngeal (NP) swabbing is being used to test for SARS-CoV-2 infection. For this, a swab&#xD;
      is inserted deep into the back of the nose to collect a sample. It can cause discomfort for&#xD;
      most people. Researchers want to find an easier way to collect samples.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To learn if testing for SARSCoV-2 with a saliva sample only, a nasal swab from just the front&#xD;
      part of the nostril only, or a saliva sample plus a nasal swab gives results that are as&#xD;
      accurate as the NP swab.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      NIH staff members age 18 and older who are taking part in NIH CC SARS-CoV-2 surveillance.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      The Occupational Medical Service (OMS) collects NP swabs as part of standard NIH staff&#xD;
      screening. Participants will give 1 or 2 saliva samples and 1 or 2 nasal swabs when their NP&#xD;
      swab is collected by OMS. If their NP swab was already collected, their OMS record will be&#xD;
      reviewed for the result.&#xD;
&#xD;
      If the NP swab result is positive, the participant will have another NP swab. At that time,&#xD;
      they will also give 1 or 2 saliva samples and 1 or 2 nasal swabs. If the NP swab result is&#xD;
      negative, they will give 1 or 2 saliva samples and 1 or 2 nasal swabs the next time they have&#xD;
      an NP swab.&#xD;
&#xD;
      For the saliva sample, participants will spit into a tube.&#xD;
&#xD;
      For the nasal swab, the inside of the front part of the nostril will be swabbed.&#xD;
&#xD;
      Participation ends after the study samples are collected. Participants can choose to keep&#xD;
      giving saliva and nasal swab samples each time they have an NP swab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Because of the inconvenience of nasopharyngeal (NP) testing for SARS-CoV-2 detection, we are&#xD;
      interested in identifying different strategies for detecting infection. A technique that is&#xD;
      less intrusive would put individuals undergoing testing at lower risk for complications,&#xD;
      would likely increase compliance with subsequent tests, and would decrease risk to the&#xD;
      providers who are conducting the test. For asymptomatic screening, some institutions are&#xD;
      using midturbinate swabs instead of NP swabs, for increased compliance due to decreased&#xD;
      discomfort. The NIH has switched to midturbinate collection in asymptomatic collections only.&#xD;
      A test that would require only expectorating saliva and/or collection of a midturbinate swab&#xD;
      would address the issues of NP collection discomfort. Saliva is the most preferred by&#xD;
      patients or asymptomatic staff due to no collection in the nasal cavity at all. Although the&#xD;
      CDC lists midturbinate swab as an acceptable specimen type, there are minimal data about the&#xD;
      sensitivity of this collection for SARS-CoV-2, and decisions to use midturbinate swabs are&#xD;
      based in part on experience with other respiratory viruses. Also, if saliva were found to be&#xD;
      equivalent to NP for patient testing, there will be a benefit to future patients in providing&#xD;
      this option for testing. Therefore, we propose to validate these sample types for SARS-CoV-2&#xD;
      detection. The RT-PCR results based on a saliva sample alone or a saliva sample coupled with&#xD;
      a midturbinate swab, will be correlated with the results using surveillance or diagnostic&#xD;
      swab samples to validate their use for SARS-CoV-2 detection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Actual">September 4, 2020</completion_date>
  <primary_completion_date type="Actual">September 4, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Saliva SARS-CoV-2 RT-PCR test results</measure>
    <time_frame>Screening</time_frame>
    <description>Validate saliva or nasal swab as a source of detection for SARS-CoV-2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Saliva and midturbinate swab SARS-CoV-2 RT-PCR test results</measure>
    <time_frame>Screening</time_frame>
    <description>Validate saliva coupled with a nasal swab as a source of detection for SARS-CoV-2.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">456</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>NIH staff</arm_group_label>
    <description>NIH staff undergoing standard NIH COVID-19 screening willing to donate additional research samples.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        NIH staff undergoing standard NIH COVID-19 screening&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        To be eligible to participate in this study, an individual must meet all of the following&#xD;
        criteria:&#xD;
&#xD;
          1. Is one of the following:&#xD;
&#xD;
               1. An NIH staff member participating in NIH CC SARS-CoV-2 surveillance, or&#xD;
&#xD;
               2. A WHC patient who had or is having a diagnostic NP RT-PCR test for SARS-CoV-2.&#xD;
&#xD;
          2. Age greater than or equal to 18 years.&#xD;
&#xD;
          3. Able to provide informed consent.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        An individual who meets any of the following criteria will be excluded from participation&#xD;
        in this study:&#xD;
&#xD;
          1. Inability or unwillingness to have NP sampling or midturbinate sampling (applies to&#xD;
             NIH site only).&#xD;
&#xD;
          2. Inability or unwillingness to provide saliva sample (applies to both NIH and WHC&#xD;
             sites).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen M Frank, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institutes of Health Clinical Center (CC)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2020-CC-0128.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>May 31, 2021</last_update_submitted>
  <last_update_submitted_qc>May 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronavirus</keyword>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2 RT-PCR</keyword>
  <keyword>Severe Acute Respiratory Syndrome Coronavirus 2</keyword>
  <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/NCT04424446
org study id: 200128
secondary id: 20-CC-0128
nct id: NCT04424446
lead sponsor: 
Background:

      Nasopharyngeal (NP) swabbing is being used to test for SARS-CoV-2 infection. For this, a swab
      is inserted deep into the back of the nose to collect a sample. It can cause discomfort for
      most people. Researchers want to find an easier way to collect samples.

      Objective:

      To learn if testing for SARSCoV-2 with a saliva sample only, a nasal swab from just the front
      part of the nostril only, or a saliva sample plus a nasal swab gives results that are as
      accurate as the NP swab.

      Eligibility:

      NIH staff members age 18 and older who are taking part in NIH CC SARS-CoV-2 surveillance.

      Design:

      The Occupational Medical Service (OMS) collects NP swabs as part of standard NIH staff
      screening. Participants will give 1 or 2 saliva samples and 1 or 2 nasal swabs when their NP
      swab is collected by OMS. If their NP swab was already collected, their OMS record will be
      reviewed for the result.

      If the NP swab result is positive, the participant will have another NP swab. At that time,
      they will also give 1 or 2 saliva samples and 1 or 2 nasal swabs. If the NP swab result is
      negative, they will give 1 or 2 saliva samples and 1 or 2 nasal swabs the next time they have
      an NP swab.

      For the saliva sample, participants will spit into a tube.

      For the nasal swab, the inside of the front part of the nostril will be swabbed.

      Participation ends after the study samples are collected. Participants can choose to keep
      giving saliva and nasal swab samples each time they have an NP swab.
Because of the inconvenience of nasopharyngeal (NP) testing for SARS-CoV-2 detection, we are
      interested in identifying different strategies for detecting infection. A technique that is
      less intrusive would put individuals undergoing testing at lower risk for complications,
      would likely increase compliance with subsequent tests, and would decrease risk to the
      providers who are conducting the test. For asymptomatic screening, some institutions are
      using midturbinate swabs instead of NP swabs, for increased compliance due to decreased
      discomfort. The NIH has switched to midturbinate collection in asymptomatic collections only.
      A test that would require only expectorating saliva and/or collection of a midturbinate swab
      would address the issues of NP collection discomfort. Saliva is the most preferred by
      patients or asymptomatic staff due to no collection in the nasal cavity at all. Although the
      CDC lists midturbinate swab as an acceptable specimen type, there are minimal data about the
      sensitivity of this collection for SARS-CoV-2, and decisions to use midturbinate swabs are
      based in part on experience with other respiratory viruses. Also, if saliva were found to be
      equivalent to NP for patient testing, there will be a benefit to future patients in providing
      this option for testing. Therefore, we propose to validate these sample types for SARS-CoV-2
      detection. The RT-PCR results based on a saliva sample alone or a saliva sample coupled with
      a midturbinate swab, will be correlated with the results using surveillance or diagnostic
      swab samples to validate their use for SARS-CoV-2 detection.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Saliva SARS-CoV-2 RT-PCR test results
time frame: Screening
description: Validate saliva or nasal swab as a source of detection for SARS-CoV-2.
measure: Saliva and midturbinate swab SARS-CoV-2 RT-PCR test results
time frame: Screening
description: Validate saliva coupled with a nasal swab as a source of detection for SARS-CoV-2.
arm group label: NIH staff
description: NIH staff undergoing standard NIH COVID-19 screening willing to donate additional research samples.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Karen M Frank, M.D.
role: Principal Investigator
affiliation: National Institutes of Health Clinical Center (CC)
facility: 
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2020-CC-0128.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: COVID-19