<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/NCT04408131</url>
  </required_header>
  <id_info>
    <org_study_id>2020-32</org_study_id>
    <secondary_id>2020-A01398-31</secondary_id>
    <nct_id>NCT04408131</nct_id>
  </id_info>
  <brief_title>Morbi-mortality by COVID-19 Among Homeless People in Marseille: a Cohort Study</brief_title>
  <acronym>COVIDHomeless</acronym>
  <official_title>Morbi-mortality by COVID-19 Among Homeless People in Marseille: a Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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>
      COVID/Homeless is a prospective observational cohort study of homeless people to determine&#xD;
      the impact of the SARS-CoV-2 epidemic on this population.&#xD;
&#xD;
      The cohort aims for exhaustiveness for the city of Marseille, being based on the active files&#xD;
      of the partner teams, namely the four emergency shelters of Marseille and 12 outreach teams&#xD;
      (including one specialized in psychiatry, three specialized in addictions, and three working&#xD;
      in squats and shantytowns).&#xD;
&#xD;
      Aims of this cohort include to identify of the prognostic factors of morbi-mortality of&#xD;
      homeless people by COVID-19, and therefore to propose appropriate management strategies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    study not started&#xD;
  </why_stopped>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Actual">May 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 27, 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>the covid mortality rate</measure>
    <time_frame>90 days</time_frame>
    <description>The mortality rate is determined by the initial clinical diagnosis and follow-up of the patient by the field team.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Homeless</condition>
  <arm_group>
    <arm_group_label>Homeless people</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood sample</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>virological test</description>
    <arm_group_label>Homeless people</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>serological test</description>
    <arm_group_label>Homeless people</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Living in the city of Marseille&#xD;
&#xD;
          -  Being homeless&#xD;
&#xD;
          -  Be over 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons under guardianship&#xD;
&#xD;
          -  Persons who refused to sign the research consent&#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>Jean-Olivier ARNAUD, Director</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <state>Paca</state>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04408131
org study id: 2020-32
secondary id: 2020-A01398-31
nct id: NCT04408131
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID/Homeless is a prospective observational cohort study of homeless people to determine
      the impact of the SARS-CoV-2 epidemic on this population.

      The cohort aims for exhaustiveness for the city of Marseille, being based on the active files
      of the partner teams, namely the four emergency shelters of Marseille and 12 outreach teams
      (including one specialized in psychiatry, three specialized in addictions, and three working
      in squats and shantytowns).

      Aims of this cohort include to identify of the prognostic factors of morbi-mortality of
      homeless people by COVID-19, and therefore to propose appropriate management strategies.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: the covid mortality rate
time frame: 90 days
description: The mortality rate is determined by the initial clinical diagnosis and follow-up of the patient by the field team.
arm group label: Homeless people
arm group type: Experimental
description: Blood sample
intervention type: Biological
intervention name: Blood sample
description: virological test
arm group label: Homeless people
intervention type: Biological
intervention name: Blood sample
description: serological test
arm group label: Homeless people
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Olivier ARNAUD, Director
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No