<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/NCT04478019</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0540</org_study_id>
    <secondary_id>A534265</secondary_id>
    <secondary_id>SMPH/MEDICINE/INFECT DIS</secondary_id>
    <secondary_id>Protocol Version 6/1/2020</secondary_id>
    <nct_id>NCT04478019</nct_id>
  </id_info>
  <brief_title>SHIELD Study: Using Naso-oropharyngeal Antiseptic Decolonization to Reduce COVID-19 Viral Shedding</brief_title>
  <acronym>SHIELD</acronym>
  <official_title>Role of NaSo-oropHaryngeal Antiseptic dEcolonizaiton to Reduce Covid-19 Viral Shedding and Disease Transmission: SHIELD Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Essential workers in positions with increased likelihood of exposure to SARS-CoC-2 will be&#xD;
      most impacted by the proposed project. Evidence has shown that the SARS-CoV-2 novel&#xD;
      coronavirus is easily transmissable through close contact between individuals, especially&#xD;
      during aerosol-generating procedures such as intubation of patients. The intervention&#xD;
      proposed in this study (nasal and oral decontamination with povidone-iodine and&#xD;
      chlorhexidine, respectively) presents an opportunity for a safe, effective, and feasible&#xD;
      treatment to decontaminate the primary entry points for SARS-CoV-2. As such, the intervention&#xD;
      to be studied in this project may protect healthcare and other essential workers by&#xD;
      preventing transmission of SARS-CoV-2 from patients to healthcare workers, as well as the&#xD;
      general public to essential worker,. and thus reducing the incidence of COVID-19 in these&#xD;
      workers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Two-period cross-over trial with a wash-out period between two study intervention periods. Participants will be randomized in a 1:1 ratio to two intervention sequences: active intervention followed by a no intervention control; or no intervention control followed by active intervention</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with COVID-19 diagnosis</measure>
    <time_frame>8 weeks</time_frame>
    <description>Participants will be monitored for positive COVID-19 test results during this trial</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-Cov-2 Viral Load</measure>
    <time_frame>8 weeks</time_frame>
    <description>Viral load will be measured as a continuous outcome for each participant (three times per week) throughout this trial.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fidelity of the treatment regimen</measure>
    <time_frame>8 weeks</time_frame>
    <description>Assessment of fidelity (as measured by percentage of compliance) to the treatment regimen will be measured by participants' reporting of intervention doses take through a daily treatment diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of the treatment regimen</measure>
    <time_frame>2 weeks total: 1 week (pre-intervention) and 1 week after completion of intervention (post-intervention)</time_frame>
    <description>A survey asking subjects to rank several factors that contribute to overall feasibility of use will be given pre- and post-intervention treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">245</enrollment>
  <condition>COVID-19</condition>
  <condition>SARS-CoV 2</condition>
  <arm_group>
    <arm_group_label>Control &gt; Active Intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment is 3 weeks of standard personal protective equipment without any povidone-iodine (PI) or chlorhexidine gluconate (CHG) intervention (control), followed by a 2 weeks washout period, and 3 weeks of nasal (10% povidone-iodine swab sticks in each nostril) and CHG oral decolonization (swish and spit 15 ml 0.12% CHG oral rinse for 30 seconds, four times/day) procedures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Intervention &gt; Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Treatment is 3 weeks of nasal (10% povidone-iodine swab sticks in each nostril) and CHG oral decolonization (swish and spit 15 ml 0.12% CHG oral rinse for 30 seconds, four times/day) procedures, followed by 2 weeks of washout, and 3 weeks of standard personal protective equipment without any PI or CHG intervention (control).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse</intervention_name>
    <description>2 swab sticks of 10% povidone-iodine in each nares and 0.12% CHG oral rinse</description>
    <arm_group_label>Active Intervention &gt; Control</arm_group_label>
    <arm_group_label>Control &gt; Active Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is a essential worker performing at least some in-person job duties (not&#xD;
             100% remote)&#xD;
&#xD;
          -  Participant is willing and able to perform intervention and data collection&#xD;
             procedures.&#xD;
&#xD;
          -  Participant is able to provide informed consent in English language.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of COVID-19 within 2 months prior to enrollment, or active respiratory&#xD;
             illness symptoms at time of enrollment&#xD;
&#xD;
          -  Known medical contraindication to chlorhexidine gluconate or povidone-iodine treatment&#xD;
             ingredients (such as a known allergy)&#xD;
&#xD;
          -  Participant has a known medical and/or surgical reason prohibiting nasal swab&#xD;
             sampling.&#xD;
&#xD;
          -  Participant is female who is pregnant, or believes she may be pregnant, at time of&#xD;
             enrollment.&#xD;
&#xD;
          -  Participant is actively taking/using any treatments or interventions as part of any&#xD;
             other COVID-19 related investigational trials.&#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>
  <location>
    <facility>
      <name>University of Wisconsin-Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 12, 2022</last_update_submitted>
  <last_update_submitted_qc>July 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>povidone-iodine</keyword>
  <keyword>chlorhexidine gluconate</keyword>
  <keyword>transmission</keyword>
  <keyword>virology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Povidone-Iodine</mesh_term>
    <mesh_term>Povidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified study results will be shared with other researchers.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will be shared after enrollment goals are reached for this study. Data will be shared via this website and publication in peer-reviewed journals.</ipd_time_frame>
  </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/NCT04478019
org study id: 2020-0540
secondary id: A534265
secondary id: SMPH/MEDICINE/INFECT DIS
secondary id: Protocol Version 6/1/2020
nct id: NCT04478019
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Essential workers in positions with increased likelihood of exposure to SARS-CoC-2 will be
      most impacted by the proposed project. Evidence has shown that the SARS-CoV-2 novel
      coronavirus is easily transmissable through close contact between individuals, especially
      during aerosol-generating procedures such as intubation of patients. The intervention
      proposed in this study (nasal and oral decontamination with povidone-iodine and
      chlorhexidine, respectively) presents an opportunity for a safe, effective, and feasible
      treatment to decontaminate the primary entry points for SARS-CoV-2. As such, the intervention
      to be studied in this project may protect healthcare and other essential workers by
      preventing transmission of SARS-CoV-2 from patients to healthcare workers, as well as the
      general public to essential worker,. and thus reducing the incidence of COVID-19 in these
      workers.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Two-period cross-over trial with a wash-out period between two study intervention periods. Participants will be randomized in a 1:1 ratio to two intervention sequences: active intervention followed by a no intervention control; or no intervention control followed by active intervention
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants with COVID-19 diagnosis
time frame: 8 weeks
description: Participants will be monitored for positive COVID-19 test results during this trial
measure: SARS-Cov-2 Viral Load
time frame: 8 weeks
description: Viral load will be measured as a continuous outcome for each participant (three times per week) throughout this trial.
measure: Fidelity of the treatment regimen
time frame: 8 weeks
description: Assessment of fidelity (as measured by percentage of compliance) to the treatment regimen will be measured by participants' reporting of intervention doses take through a daily treatment diary.
measure: Feasibility of the treatment regimen
time frame: 2 weeks total: 1 week (pre-intervention) and 1 week after completion of intervention (post-intervention)
description: A survey asking subjects to rank several factors that contribute to overall feasibility of use will be given pre- and post-intervention treatment.
arm group label: Control > Active Intervention
arm group type: Other
description: Treatment is 3 weeks of standard personal protective equipment without any povidone-iodine (PI) or chlorhexidine gluconate (CHG) intervention (control), followed by a 2 weeks washout period, and 3 weeks of nasal (10% povidone-iodine swab sticks in each nostril) and CHG oral decolonization (swish and spit 15 ml 0.12% CHG oral rinse for 30 seconds, four times/day) procedures.
arm group label: Active Intervention > Control
arm group type: Other
description: Treatment is 3 weeks of nasal (10% povidone-iodine swab sticks in each nostril) and CHG oral decolonization (swish and spit 15 ml 0.12% CHG oral rinse for 30 seconds, four times/day) procedures, followed by 2 weeks of washout, and 3 weeks of standard personal protective equipment without any PI or CHG intervention (control).
intervention type: Drug
intervention name: 10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse
description: 2 swab sticks of 10% povidone-iodine in each nares and 0.12% CHG oral rinse
arm group label: Active Intervention > Control
arm group label: Control > Active Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Povidone-Iodine
mesh term: Povidone
sharing ipd: Yes
ipd description: De-identified study results will be shared with other researchers.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will be shared after enrollment goals are reached for this study. Data will be shared via this website and publication in peer-reviewed journals.