<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/NCT04441710</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL20_0395</org_study_id>
    <nct_id>NCT04441710</nct_id>
  </id_info>
  <brief_title>Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus</brief_title>
  <acronym>CoVid3S</acronym>
  <official_title>Caregiver Serological Monitoring Extended Secondarily to Patients With the SARS-CoV-2 Coronavirus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hospital mortality attributed to SARS-CoV-2 in France increased daily by 28% in the week&#xD;
      before confinement. The week following this decision, the daily increase was 30%. During the&#xD;
      week of the second week of confinement, it started a decline of 19% estimated over the last 5&#xD;
      days, reaching the cumulative number of 2606 deaths on 29/3 (site&#xD;
      https://www.eficiens.com/coronavirus- personal statistics / and calculation).&#xD;
&#xD;
      The diagnosis of viral carriage by RT-PCR is reserved for symptomatic cases among caregivers,&#xD;
      due to the shortage of available tests and the cumbersome implementation. The carrier&#xD;
      diagnosis is the benchmark, on which are implemented the therapeutic strategies and&#xD;
      established the national statistics. It can present false negatives, linked to a research too&#xD;
      early or too late in relation to the infection, or to a technical defect of the nasal swab&#xD;
      sample. Caregivers on the front line in patient care, in hospitals or in the city, have only&#xD;
      partial access to this diagnostic test, depending on the existence of symptoms. The&#xD;
      implementation of a systematic serological screening, planned by the government and which&#xD;
      cannot be based only on the search for the virus, will make it possible to inform the&#xD;
      caregivers presenting symptoms or not, of their serological status, and therefore of their&#xD;
      degree immunity or, on the contrary, susceptibility to infectious contacts. It should&#xD;
      therefore be very voluntarily requested. On the occasion of this screening, the constitution&#xD;
      of the COVID-3S cohort will make it possible to verify the degree of contamination in an&#xD;
      asymptomatic population, information which is sorely lacking for the estimation of the immune&#xD;
      coverage of the population. The implementation of the Covid-3S study will be based on the&#xD;
      work of the National Reference Center of Pr B Lina, from the COVID-SER cohort, for the&#xD;
      selection of the most efficient test (s). It seems useful to initiate the constitution of&#xD;
      this cohort as soon as possible in relation to the evolution of the epidemic. Pending receipt&#xD;
      of official recommendations, the lack of knowledge of the performance of serological tests&#xD;
      means that it should be applied first to health professionals, better able to appreciate its&#xD;
      limits, for the initial period before determining a validated serological screening strategy.&#xD;
      Once the strategy has been specified, the gradual expansion of screening to the patient&#xD;
      population will provide a more representative basis for the construction of epidemiological&#xD;
      models for evaluating strategies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 27, 2020</start_date>
  <completion_date type="Actual">December 16, 2022</completion_date>
  <primary_completion_date type="Actual">December 16, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>18 Months</target_duration>
  <primary_outcome>
    <measure>Establishment of a reliable prediction model for the effectiveness of virus control</measure>
    <time_frame>18 months</time_frame>
    <description>Estimated number of deaths avoided by the various population protection strategies, estimated by applying these strategies to the realistic virtual population.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">2777</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Caregivers</arm_group_label>
    <description>Staff of university hospitals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary care caregivers</arm_group_label>
    <description>Population of professional caregivers such as general practitioner or freelance nurse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Participants will be invited to complete a detailed questionnaire to collect prospectively and retrospectively data around the CoViD19 serological screening.</description>
    <arm_group_label>Caregivers</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_label>Primary care caregivers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Prospective cohort of voluntary caregivers, initially recruited in the CHUs concerned, then&#xD;
        among the primary care caregivers, finally among the patients whom these caregivers care&#xD;
        for.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any adult having passed a serological, antigenical or any other type of test in&#xD;
             France, and voluntary to participate in the cohort and/or vaccinated against COVID19&#xD;
&#xD;
          -  Any child under 18 who has passed a serological, antigenical, or any other type of&#xD;
             test in France, willing to participate and at least one of whose parents has accepted&#xD;
             to participate in the cohort, and/or vaccinated against COVID19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons deprived of their liberty&#xD;
&#xD;
          -  Adults over whom legal protection applies: guardianship, curatorship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pascal FASCIA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <overall_official>
    <last_name>François GUEYFFIER, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Grenoble - Hôpital Nord</name>
      <address>
        <city>La Tronche</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Croix Rousse</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Henry Gabrielle</name>
      <address>
        <city>Saint-Genis-Laval</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Saint Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-COV-2</keyword>
  <keyword>Serology</keyword>
  <keyword>Predictability</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</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/NCT04441710
org study id: 69HCL20_0395
nct id: NCT04441710
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hospital mortality attributed to SARS-CoV-2 in France increased daily by 28% in the week
      before confinement. The week following this decision, the daily increase was 30%. During the
      week of the second week of confinement, it started a decline of 19% estimated over the last 5
      days, reaching the cumulative number of 2606 deaths on 29/3 (site
      https://www.eficiens.com/coronavirus- personal statistics / and calculation).

      The diagnosis of viral carriage by RT-PCR is reserved for symptomatic cases among caregivers,
      due to the shortage of available tests and the cumbersome implementation. The carrier
      diagnosis is the benchmark, on which are implemented the therapeutic strategies and
      established the national statistics. It can present false negatives, linked to a research too
      early or too late in relation to the infection, or to a technical defect of the nasal swab
      sample. Caregivers on the front line in patient care, in hospitals or in the city, have only
      partial access to this diagnostic test, depending on the existence of symptoms. The
      implementation of a systematic serological screening, planned by the government and which
      cannot be based only on the search for the virus, will make it possible to inform the
      caregivers presenting symptoms or not, of their serological status, and therefore of their
      degree immunity or, on the contrary, susceptibility to infectious contacts. It should
      therefore be very voluntarily requested. On the occasion of this screening, the constitution
      of the COVID-3S cohort will make it possible to verify the degree of contamination in an
      asymptomatic population, information which is sorely lacking for the estimation of the immune
      coverage of the population. The implementation of the Covid-3S study will be based on the
      work of the National Reference Center of Pr B Lina, from the COVID-SER cohort, for the
      selection of the most efficient test (s). It seems useful to initiate the constitution of
      this cohort as soon as possible in relation to the evolution of the epidemic. Pending receipt
      of official recommendations, the lack of knowledge of the performance of serological tests
      means that it should be applied first to health professionals, better able to appreciate its
      limits, for the initial period before determining a validated serological screening strategy.
      Once the strategy has been specified, the gradual expansion of screening to the patient
      population will provide a more representative basis for the construction of epidemiological
      models for evaluating strategies.
observational model: Cohort
time perspective: Prospective
measure: Establishment of a reliable prediction model for the effectiveness of virus control
time frame: 18 months
description: Estimated number of deaths avoided by the various population protection strategies, estimated by applying these strategies to the realistic virtual population.
arm group label: Caregivers
description: Staff of university hospitals
arm group label: Primary care caregivers
description: Population of professional caregivers such as general practitioner or freelance nurse.
arm group label: Patients
intervention type: Other
intervention name: Questionnaire
description: Participants will be invited to complete a detailed questionnaire to collect prospectively and retrospectively data around the CoViD19 serological screening.
arm group label: Caregivers
arm group label: Patients
arm group label: Primary care caregivers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Pascal FASCIA, MD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
last name: François GUEYFFIER, MD
role: Study Director
affiliation: Hospices Civils de Lyon
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Coronavirus Infections