<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/NCT04438070</url>
  </required_header>
  <id_info>
    <org_study_id>2020-10864-T</org_study_id>
    <nct_id>NCT04438070</nct_id>
  </id_info>
  <brief_title>COVID Screening Strategies in Homeless Shelters</brief_title>
  <official_title>COVID Screening Strategies in Homeless Shelters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Joseph's Healthcare Hamilton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Timothy O'Shea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Marek Smieja</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lawrence Mbuagbaw</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Joseph's Healthcare Hamilton</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>
      Residents in homeless shelters will be randomized to 4 different COVID-19 screening&#xD;
      strategies with the primary outcome being COVID-19 detection rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 10, 2020</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Cluster randomized multi-center trial</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>COVID-19 Detection Rate</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of outbreaks</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enrollment over time</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Daily active screening only</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Daily active screening and self-collected nasal swab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Daily active screening and self-collected oral-nasal swab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Daily active screening and nurse collected nasopharyngeal swab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>COVID-19 Swab</intervention_name>
    <description>Nasal, Oral-Nasal combined or Nasopharyngeal swab</description>
    <arm_group_label>Daily active screening and nurse collected nasopharyngeal swab</arm_group_label>
    <arm_group_label>Daily active screening and self-collected nasal swab</arm_group_label>
    <arm_group_label>Daily active screening and self-collected oral-nasal swab</arm_group_label>
    <arm_group_label>Daily active screening only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18&#xD;
&#xD;
          -  Able to provide oral consent&#xD;
&#xD;
          -  Able to perform a self-collected swab if in the relevant intervention arm&#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>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Timothy O'Shea, MD</last_name>
    <phone>905-521-2100</phone>
    <email>osheat@mcmaster.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marek Smieja, MD, PhD</last_name>
    <phone>905-521-6021</phone>
    <email>msmieja@stjosham.on.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Various Homeless Shelters</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Timothy O'Shea, MD</last_name>
      <phone>905-521-2100</phone>
      <email>osheat@mcmaster.ca</email>
    </contact>
    <investigator>
      <last_name>Timothy O'Shea, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Joseph's Healthcare Hamilton</investigator_affiliation>
    <investigator_full_name>Marek Smieja</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04438070
org study id: 2020-10864-T
nct id: NCT04438070
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Residents in homeless shelters will be randomized to 4 different COVID-19 screening
      strategies with the primary outcome being COVID-19 detection rate.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Cluster randomized multi-center trial
primary purpose: Screening
masking: None (Open Label)
measure: COVID-19 Detection Rate
time frame: 8 weeks
measure: Number of outbreaks
time frame: 8 weeks
measure: Enrollment over time
time frame: 8 weeks
arm group label: Daily active screening only
arm group type: Placebo Comparator
arm group label: Daily active screening and self-collected nasal swab
arm group type: Experimental
arm group label: Daily active screening and self-collected oral-nasal swab
arm group type: Experimental
arm group label: Daily active screening and nurse collected nasopharyngeal swab
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: COVID-19 Swab
description: Nasal, Oral-Nasal combined or Nasopharyngeal swab
arm group label: Daily active screening and nurse collected nasopharyngeal swab
arm group label: Daily active screening and self-collected nasal swab
arm group label: Daily active screening and self-collected oral-nasal swab
arm group label: Daily active screening only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Timothy O'Shea, MD
phone: 905-521-2100
email: osheat@mcmaster.ca
last name: Marek Smieja, MD, PhD
phone: 905-521-6021
email: msmieja@stjosham.on.ca
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Joseph's Healthcare Hamilton
investigator full name: Marek Smieja
investigator title: Principal Investigator
sharing ipd: Undecided