<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/NCT04441684</url>
  </required_header>
  <id_info>
    <org_study_id>7782</org_study_id>
    <nct_id>NCT04441684</nct_id>
  </id_info>
  <brief_title>Seroprevalence of SARS-CoV-2 in Strasbourg University Hospital, Strasbourg, France (COVID-19)</brief_title>
  <acronym>SeroCoV-HUS</acronym>
  <official_title>Study of the Seroprevalence of SARS-CoV-2 in Hospital Staff in Strasbourg University Hospital, Strasbourg, France</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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-19 is a new emerging disease caused by infection with the SARS-CoV-2 coronavirus, with&#xD;
      no specific therapeutic options.&#xD;
&#xD;
      Since the end of February 2020, the Strasbourg University Hospital (HUS) had faced a sudden&#xD;
      increase of patients with COVID-19 resulted from a SARS-CoV-2 superspreading event (religious&#xD;
      meeting). Infected individuals went to regional hospitals, and this led to a cluster of&#xD;
      infected healthcare workers at the Strasbourg University Hospitals from the first week of&#xD;
      March. To date, several hundred Strasbourg hospital workers have presented a SARS-CoV-2&#xD;
      infection confirmed by the RT-PCR test from a nasopharyngeal sample. Most of them developed a&#xD;
      mild form of COVID-19.&#xD;
&#xD;
      It is important to understand how far the infection has spread in the hospital staff, and to&#xD;
      which extent the individuals who have been infected develop antibodies against SARS-CoV-2.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2020</start_date>
  <completion_date type="Actual">July 16, 2021</completion_date>
  <primary_completion_date type="Actual">May 7, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of specific SARS-CoV2 antibodies in the serum in the 3 groups of subjects studied, at the inclusion visit (D0).</measure>
    <time_frame>inclusion visit (Day 0).</time_frame>
    <description>Presence of specific SARS-CoV2 antibodies in the serum in the 3 groups of subjects studied, at the inclusion visit (D0).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detection and titration of neutralizing antibodies anti-SARS-CoV-2</measure>
    <time_frame>At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinetics of antibodies and their persistence over a period of 1 year</measure>
    <time_frame>At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of asymptomatic subjects in the PCR - and -PCR groups</measure>
    <time_frame>At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of people with positive Sars-CoV-2 serology</measure>
    <time_frame>At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire (Type of health care personnel, Contact history, medical operation and respect of hygiene standards)</measure>
    <time_frame>At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Analysis of the T cell response by the ELISPOT technique</measure>
    <time_frame>At one of the follow up visit : Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) or Month 12 (Day 0+12 months).</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>B cell repertoire sequencing</measure>
    <time_frame>At one of the follow up visit : Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) or Month 12 (Day 0+12 months).</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Sequencing of cellular SARS-CoV2 receptors</measure>
    <time_frame>At one of the follow up visit : Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) or Month 12 (Day 0+12 months).</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1466</enrollment>
  <condition>SARS-CoV-2 Serological Status</condition>
  <condition>SARS-CoV-2 Seroprevalence</condition>
  <arm_group>
    <arm_group_label>PCR+ group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group includes any symptomatic person with a positive COVID result, with a RT-PCR test carried out at least 10 days before inclusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PCR- group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group includes any symptomatic person with a negative RT-PCR COVID 19 test carried out at least 10 days before inclusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No PCR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group includes any person, for which no COVID 19 RT- PCR testing was performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood sample for serological test</intervention_name>
    <description>Serology tests:&#xD;
By LFA-ICT: BIOSYNEX COVID-19 BSS reference SW40005, BIOSYNEX SWISS SA, Fribourg, Switzerland&#xD;
ELISA: EDI™ Novel Coronavirus COVID-19 ELISA IgG Kit, Epitope Diagnostics, Inc., San Diego, USA&#xD;
Confirmation test by seroneutralization tests developed at the Strasbourg Virology laboratory on whole virus (analyzes performed in a biosafety level 3 laboratory) and by the viral pseudoparticles system, will be performed.</description>
    <arm_group_label>No PCR</arm_group_label>
    <arm_group_label>PCR+ group</arm_group_label>
    <arm_group_label>PCR- group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any person, male or female, over 18 years of age at the time of signing the consent&#xD;
&#xD;
          -  Any person affiliated to a social health insurance scheme&#xD;
&#xD;
          -  Any person able to understand the objectives and risks related to research and to give&#xD;
             an informed, dated and signed consent&#xD;
&#xD;
          -  Any person who is part of HUS staff and working at HUS at the time of the pandemic,&#xD;
             including residents affiliated with HUS and assigned to general hospitals in the&#xD;
             region&#xD;
&#xD;
          -  Any symptomatic person with a positive COVID result (PCR + group) or negative (PCR-&#xD;
             group) with a RT-PCR test carried out at least 10 days before inclusion, or any&#xD;
             person, for which no COVID PCR was performed (group &quot; No PCR&quot;)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Person in exclusion period (determined by a previous or ongoing study),&#xD;
&#xD;
          -  Inability to give clear information (person in an emergency, difficulty understanding&#xD;
             the subject, etc.)&#xD;
&#xD;
          -  Person under safeguard of justice&#xD;
&#xD;
          -  Person under guardianship or curatorship&#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>Hôpitaux Universitaires de Strasbourg - Centre d'Investigation Clinique - Nouvel Hôpital Civil et Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Humoral response</keyword>
  <keyword>T-cell response</keyword>
  <!-- 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/NCT04441684
org study id: 7782
nct id: NCT04441684
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19 is a new emerging disease caused by infection with the SARS-CoV-2 coronavirus, with
      no specific therapeutic options.

      Since the end of February 2020, the Strasbourg University Hospital (HUS) had faced a sudden
      increase of patients with COVID-19 resulted from a SARS-CoV-2 superspreading event (religious
      meeting). Infected individuals went to regional hospitals, and this led to a cluster of
      infected healthcare workers at the Strasbourg University Hospitals from the first week of
      March. To date, several hundred Strasbourg hospital workers have presented a SARS-CoV-2
      infection confirmed by the RT-PCR test from a nasopharyngeal sample. Most of them developed a
      mild form of COVID-19.

      It is important to understand how far the infection has spread in the hospital staff, and to
      which extent the individuals who have been infected develop antibodies against SARS-CoV-2.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Presence of specific SARS-CoV2 antibodies in the serum in the 3 groups of subjects studied, at the inclusion visit (D0).
time frame: inclusion visit (Day 0).
description: Presence of specific SARS-CoV2 antibodies in the serum in the 3 groups of subjects studied, at the inclusion visit (D0).
measure: Detection and titration of neutralizing antibodies anti-SARS-CoV-2
time frame: At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).
measure: Kinetics of antibodies and their persistence over a period of 1 year
time frame: At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).
measure: Number of asymptomatic subjects in the PCR - and -PCR groups
time frame: At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).
measure: Number of people with positive Sars-CoV-2 serology
time frame: At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).
measure: Questionnaire (Type of health care personnel, Contact history, medical operation and respect of hygiene standards)
time frame: At Day 0 and each follow-up visits i.e. at Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) and Month 12 (Day 0+12 months).
measure: Analysis of the T cell response by the ELISPOT technique
time frame: At one of the follow up visit : Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) or Month 12 (Day 0+12 months).
measure: B cell repertoire sequencing
time frame: At one of the follow up visit : Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) or Month 12 (Day 0+12 months).
measure: Sequencing of cellular SARS-CoV2 receptors
time frame: At one of the follow up visit : Month 3 (Day 0+3 months), Month 6 (Day 0+6 months) or Month 12 (Day 0+12 months).
arm group label: PCR+ group
arm group type: Experimental
description: This group includes any symptomatic person with a positive COVID result, with a RT-PCR test carried out at least 10 days before inclusion.
arm group label: PCR- group
arm group type: Experimental
description: This group includes any symptomatic person with a negative RT-PCR COVID 19 test carried out at least 10 days before inclusion.
arm group label: No PCR
arm group type: Experimental
description: This group includes any person, for which no COVID 19 RT- PCR testing was performed.
intervention type: Diagnostic Test
intervention name: Blood sample for serological test
description: Serology tests:
By LFA-ICT: BIOSYNEX COVID-19 BSS reference SW40005, BIOSYNEX SWISS SA, Fribourg, Switzerland
ELISA: EDI™ Novel Coronavirus COVID-19 ELISA IgG Kit, Epitope Diagnostics, Inc., San Diego, USA
Confirmation test by seroneutralization tests developed at the Strasbourg Virology laboratory on whole virus (analyzes performed in a biosafety level 3 laboratory) and by the viral pseudoparticles system, will be performed.
arm group label: No PCR
arm group label: PCR+ group
arm group label: PCR- group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor