<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/NCT04408001</url>
  </required_header>
  <id_info>
    <org_study_id>2020-COVID19-04</org_study_id>
    <secondary_id>2020-A01019-30</secondary_id>
    <nct_id>NCT04408001</nct_id>
  </id_info>
  <brief_title>Study of Kinetics and Efficacy of the Immune Response Against COVID-19 Among Hospital Staff</brief_title>
  <acronym>IMMUNO-COVID</acronym>
  <official_title>Study of Kinetics and Efficacy of the Immune Response Against COVID-19 Among Hospital Staff</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Direction Centrale du Service de Santé des Armées</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Direction Centrale du Service de Santé des Armées</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 pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae&#xD;
      family that emerged in China in December 2019 before rapidly becoming a pandemic according to&#xD;
      the WHO on March 11, 2020. The epidemic affected France from February 2020. On February 24, a&#xD;
      patient hospitalized at Percy hospital was the cause of a major nosocomial epidemic,&#xD;
      potentially responsible for more than 250 symptomatic people in the hospital as of April 6.&#xD;
      The outbreak was identified by Percy hospital management on March 16, and barrier measures&#xD;
      were immediately put in place. From March 20, a mixed investigation unit set up a chain of&#xD;
      nasopharyngeal swabs for Percy hospital staff.&#xD;
&#xD;
      A COVID-19 case reporting unit was set up at Percy hospital in response to the identification&#xD;
      of the outbreak within the hospital. This unit carried out rapid identification and regular&#xD;
      follow-up until the return to work of the staff. Thus all symptomatic patients are identified&#xD;
      and the COVID-19 case census cell will follow all Percy hospital staff, including volunteers&#xD;
      recruited to deal with the epidemic, throughout the duration of the epidemic. This&#xD;
      population, captive by nature, will be one of the few described in the world during this&#xD;
      epidemic.&#xD;
&#xD;
      Current data on short-, medium- and long-term immunity induced by COVID-19 infection are&#xD;
      fragmentary, as is the existence of a large asymptomatic population, making it difficult to&#xD;
      cut the chains of transmission in the absence of an effective diagnostic tool.&#xD;
&#xD;
      Another important issue is the quality of immunity induced by the infection, as it conditions&#xD;
      the future of the pandemic, which could become endemic and recurrent if immunity were not&#xD;
      sterilizing. As yet unpublished data in primates show that in the primate model re-infection&#xD;
      is not possible in the short term, while patients cured from the Wuhan epidemic seem to be&#xD;
      detected again positive for virus shedding.&#xD;
&#xD;
      The objective of this study is to characterize the immunity (systemic and local) induced by&#xD;
      SARS-Cov-2 infection among Percy hospital staff who are at high risk of contamination even in&#xD;
      a period of confinement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Actual">March 15, 2022</completion_date>
  <primary_completion_date type="Actual">March 15, 2022</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Induced SARS-CoV2 immunity</measure>
    <time_frame>At day 21 (compared to enrollment [Day 0])</time_frame>
    <description>The presence of induced immunity will be identified by an Ig family switch on the first two serologies with a high titre of specific IgG and disappearance of IgM.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long-term protection of induced SARS-CoV2 immunity at 6 months</measure>
    <time_frame>6 months following enrollment</time_frame>
    <description>The presence of induced immunity will be identified on serology analysis at 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long-term protection of induced SARS-CoV2 immunity at 1 year</measure>
    <time_frame>1 year following enrollment</time_frame>
    <description>The presence of induced immunity will be identified on serology analysis at 1 year.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-SARS-CoV2 antibodies kinetics in blood throughout the study</measure>
    <time_frame>From enrollment (Day 0) to 1 year after enrollement</time_frame>
    <description>Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-SARS-CoV2 antibodies kinetics in saliva throughout the study</measure>
    <time_frame>From enrollment (Day 0) to 1 year after enrollement</time_frame>
    <description>Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on saliva samples from enrollment (Day 0) to 1 year after enrollement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kinetics of serum neutralization in blood throughout the study</measure>
    <time_frame>From enrollment (Day 0) to 1 year after enrollement</time_frame>
    <description>Kinetics of serum neutralization against SARS-CoV-2 positive using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 0</measure>
    <time_frame>At enrollment (Day 0)</time_frame>
    <description>Anti-SARS-Cov2 seroprevalence measured in serum samples collected at Day 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 21</measure>
    <time_frame>At Day 21</time_frame>
    <description>Anti-SARS-Cov2 seroprevalence measured in serum samples collected at Day 21.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">499</enrollment>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>Symptomatic individuals</arm_group_label>
    <description>Hospital staff identified by the COVID-19 case census cell :&#xD;
who have been infected (confirmed by a positive RT-PCR result on a nasopharyngeal swab)&#xD;
OR who have displayed clinical signs compatible with COVID-19 despite a negative RT-PCR result.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asymptomatic individuals</arm_group_label>
    <description>Hospital staff who have not been identified by the COVID-19 case census cell.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical interview</intervention_name>
    <description>At each study visit, participants will be questioned by a physician about their persistent symptoms or the existence of intercurrent infections that may resemble COVID-19.</description>
    <arm_group_label>Asymptomatic individuals</arm_group_label>
    <arm_group_label>Symptomatic individuals</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood collection</intervention_name>
    <description>At each study visit,&#xD;
1 EDTA tube for complete blood count&#xD;
3 dry tubes with gel for serology, serum neutralisation test and serum library&#xD;
1 cell preparation tube for the separation of immune cells within the circulating blood will be collected.</description>
    <arm_group_label>Asymptomatic individuals</arm_group_label>
    <arm_group_label>Symptomatic individuals</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Saliva collection</intervention_name>
    <description>At each study visit, a saliva sample will be collected for the determination of IgA antibodies.</description>
    <arm_group_label>Asymptomatic individuals</arm_group_label>
    <arm_group_label>Symptomatic individuals</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum samples ans saliva samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Percy hospital staff having (symptomatic individuals group) or not (asymptomatic&#xD;
        individuals group) presented COVID-19 infection symptoms.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older;&#xD;
&#xD;
          -  Military or civilian or contactual volunteer on duty at Percy hospital during the&#xD;
             COVID-19 pandemic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who have displayed a severe form of early-onset COVID-19 who required&#xD;
             intensive care management or hospitalization;&#xD;
&#xD;
          -  Presence of factors modulating immunity with congenital or acquired immunosuppression:&#xD;
&#xD;
               -  Medication: cancer chemotherapy, immunosuppressive drugs, biotherapy,&#xD;
                  corticosteroids&#xD;
&#xD;
               -  Uncontrolled HIV infection or CD4 &lt;200/mm3 infection&#xD;
&#xD;
               -  History of solid organ or hematopoietic stem cell transplants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital d'Instuction des Armées Percy</name>
      <address>
        <city>Clamart</city>
        <zip>92140</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 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>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04408001
org study id: 2020-COVID19-04
secondary id: 2020-A01019-30
nct id: NCT04408001
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
COVID-19 is a pathology linked to the SARS-CoV-2 virus, a new virus of the coronaviridae
      family that emerged in China in December 2019 before rapidly becoming a pandemic according to
      the WHO on March 11, 2020. The epidemic affected France from February 2020. On February 24, a
      patient hospitalized at Percy hospital was the cause of a major nosocomial epidemic,
      potentially responsible for more than 250 symptomatic people in the hospital as of April 6.
      The outbreak was identified by Percy hospital management on March 16, and barrier measures
      were immediately put in place. From March 20, a mixed investigation unit set up a chain of
      nasopharyngeal swabs for Percy hospital staff.

      A COVID-19 case reporting unit was set up at Percy hospital in response to the identification
      of the outbreak within the hospital. This unit carried out rapid identification and regular
      follow-up until the return to work of the staff. Thus all symptomatic patients are identified
      and the COVID-19 case census cell will follow all Percy hospital staff, including volunteers
      recruited to deal with the epidemic, throughout the duration of the epidemic. This
      population, captive by nature, will be one of the few described in the world during this
      epidemic.

      Current data on short-, medium- and long-term immunity induced by COVID-19 infection are
      fragmentary, as is the existence of a large asymptomatic population, making it difficult to
      cut the chains of transmission in the absence of an effective diagnostic tool.

      Another important issue is the quality of immunity induced by the infection, as it conditions
      the future of the pandemic, which could become endemic and recurrent if immunity were not
      sterilizing. As yet unpublished data in primates show that in the primate model re-infection
      is not possible in the short term, while patients cured from the Wuhan epidemic seem to be
      detected again positive for virus shedding.

      The objective of this study is to characterize the immunity (systemic and local) induced by
      SARS-Cov-2 infection among Percy hospital staff who are at high risk of contamination even in
      a period of confinement.
observational model: Cohort
time perspective: Prospective
measure: Induced SARS-CoV2 immunity
time frame: At day 21 (compared to enrollment [Day 0])
description: The presence of induced immunity will be identified by an Ig family switch on the first two serologies with a high titre of specific IgG and disappearance of IgM.
measure: Long-term protection of induced SARS-CoV2 immunity at 6 months
time frame: 6 months following enrollment
description: The presence of induced immunity will be identified on serology analysis at 6 months.
measure: Long-term protection of induced SARS-CoV2 immunity at 1 year
time frame: 1 year following enrollment
description: The presence of induced immunity will be identified on serology analysis at 1 year.
measure: Anti-SARS-CoV2 antibodies kinetics in blood throughout the study
time frame: From enrollment (Day 0) to 1 year after enrollement
description: Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollement
measure: Anti-SARS-CoV2 antibodies kinetics in saliva throughout the study
time frame: From enrollment (Day 0) to 1 year after enrollement
description: Kinetics of anti-SARS-CoV-2 antibodies using ELISA technique on saliva samples from enrollment (Day 0) to 1 year after enrollement
measure: Kinetics of serum neutralization in blood throughout the study
time frame: From enrollment (Day 0) to 1 year after enrollement
description: Kinetics of serum neutralization against SARS-CoV-2 positive using ELISA technique on serum samples from enrollment (Day 0) to 1 year after enrollement.
measure: Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 0
time frame: At enrollment (Day 0)
description: Anti-SARS-Cov2 seroprevalence measured in serum samples collected at Day 0.
measure: Anti-SARS-CoV2 seroprevalence in asymptomatic individuals at Day 21
time frame: At Day 21
description: Anti-SARS-Cov2 seroprevalence measured in serum samples collected at Day 21.
arm group label: Symptomatic individuals
description: Hospital staff identified by the COVID-19 case census cell :
who have been infected (confirmed by a positive RT-PCR result on a nasopharyngeal swab)
OR who have displayed clinical signs compatible with COVID-19 despite a negative RT-PCR result.
arm group label: Asymptomatic individuals
description: Hospital staff who have not been identified by the COVID-19 case census cell.
intervention type: Other
intervention name: Clinical interview
description: At each study visit, participants will be questioned by a physician about their persistent symptoms or the existence of intercurrent infections that may resemble COVID-19.
arm group label: Asymptomatic individuals
arm group label: Symptomatic individuals
intervention type: Biological
intervention name: Blood collection
description: At each study visit,
1 EDTA tube for complete blood count
3 dry tubes with gel for serology, serum neutralisation test and serum library
1 cell preparation tube for the separation of immune cells within the circulating blood will be collected.
arm group label: Asymptomatic individuals
arm group label: Symptomatic individuals
intervention type: Biological
intervention name: Saliva collection
description: At each study visit, a saliva sample will be collected for the determination of IgA antibodies.
arm group label: Asymptomatic individuals
arm group label: Symptomatic individuals
Serum samples ans saliva samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided