<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/NCT04418375</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200609</org_study_id>
    <secondary_id>APHP200609</secondary_id>
    <secondary_id>2020-A01364-35</secondary_id>
    <nct_id>NCT04418375</nct_id>
  </id_info>
  <brief_title>Establishment of a Biological Collection During COVID-19 Serological Screening in APHP Professionals (COVID-HOP)</brief_title>
  <acronym>COVID-HOP</acronym>
  <official_title>Identification of Markers Associated With the Risk of COVID-19 Infection and Symptomatic COVID+ Versus Asymptomatic COVID+ Status Through the Establishment of a Biological Collection During Serological Screening in APHP Professionals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondation Université de Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fondation Hôpitaux de Paris-Hôpitaux de France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      The objective of the COVID-HOP study is to identify biological and non-biological markers&#xD;
      associated to: a positive or negative serology anti SRAS-Cov-2; a positive serology and&#xD;
      having presented symptoms or, on the contrary, not having had symptoms; the persistence of&#xD;
      immunity or the loss of this immunity over time; the protective nature of the presence of&#xD;
      anti SRAS-Cov-2 antibodies.&#xD;
&#xD;
      To answer these questions, a biological collection (serum, plasma, DNA, RNA, mono-nucleated&#xD;
      cells and urine) and a collection of detailed clinical data during the serological screening&#xD;
      for SARS-CoV-2 of hospital agents (medical and non-medical staff) of the Assistance Publique&#xD;
      Hôpitaux de Paris (Paris, France) will be carried out. 4000 professionals in 5 hospitals will&#xD;
      be included. As part of the research, the anti SRAS-CoV-2 serology will be monitored 6 months&#xD;
      and 12 months after the initial serology. Numerous studies will be carried out from this&#xD;
      biological collection and from the database to answer the primary and secondary endpoints.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To answer the questions raised in the primary and secondary endpoints, a biological&#xD;
      collection (serum, plasma, DNA, RNA, mono-nucleated cells and urine) and a collection of&#xD;
      detailed data by the mean of a questionnaire (demographic, clinical, lifestyle, professional&#xD;
      exposure to the virus, COVID-19 infection with detailed symptoms and complications) during&#xD;
      the serological screening for SARS-CoV-2 of hospital agents (medical and non-medical staff)&#xD;
      of the Assistance Publique Hôpitaux de Paris (Paris, France) will be carried out. 4000&#xD;
      professionals in 5 hospitals of the Assistance Publique Hôpitaux de Paris. As part of the&#xD;
      research, the anti SRAS-CoV-2 serology will be monitored 6 months (M6) and 12 months (M12)&#xD;
      after the initial serology and a brief questionnaire (update regarding treatments,&#xD;
      co-morbidities, and COVID-19 infection) will be fulfilled at these two time points. Of note,&#xD;
      if the inclusion could not be performed during the initial serological screening, the&#xD;
      professional will be recalled to be included at M6.&#xD;
&#xD;
      Statistical analysis: The analysis of the determinants independently associated with&#xD;
      symptomatic COVID + status will be carried out by uni- and multivariate logistic regression.&#xD;
      The internal validation will be carried out by methods of draw with discount (bootstrap). The&#xD;
      performance of the model will include calibration (graphical method) and discrimination&#xD;
      (AUC). The biomarker study will include the study of the association with COVID + symptomatic&#xD;
      versus asymptomatic status by univariate then multivariate analyzes (logistic regression)&#xD;
      including clinical variables. The additional value of biomarkers will be studied by comparing&#xD;
      the discriminating power of clinical models with and without the new biomarker. Finally, the&#xD;
      study of the heterogeneity of COVID + symptomatic and asymptomatic patients will be carried&#xD;
      out by an unsupervised analysis of Machine Learning known as archetypes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">October 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>Identification of markers associated with asymptomatic COVID + status (results of the serological test) versus symptomatic COVID + status through a questionnaire (medical history, work environment, lifestyle) and a biological collection</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification of markers associated with a positive or a negative serology through a questionnaire (medical history, work environment, lifestyle) and a biological collection</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the serological status according to the professional risk of exposure to the virus</measure>
    <time_frame>12 months</time_frame>
    <description>The level of risk of occupational exposure to SARS-CoV-2 will be described in detailed (type of activity during the COVID-19 pandemic, type of protection during this activity...)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the clinical manifestations of COVID-19 infection in hospital professionals</measure>
    <time_frame>12 months</time_frame>
    <description>All the potential clinical signs of a COVID-19 infection and its complication will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of risk factors associated with the loss of anti SARS-CoV-2 immunity through a questionnaire (medical history, work environment, lifestyle) and a biological collection</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of markers associated with symptomatic COVID-19 infection during follow-up despite the presence of anti SARS-CoV-2 antibodies through a questionnaire (medical history, work environment, lifestyle) and a biological collection</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the serology result and the PCR result (swabs) for people who have been tested as part of routine care.</measure>
    <time_frame>12 months</time_frame>
    <description>Correlation between the serology result and the PCR result (swabs) for people who have been tested by PCR as part of routine care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of potential therapeutic targets to avoid developing a symptomatic form</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>purpose of potential ancillary studies using the biological collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification of potential therapeutic targets to promote the maintenance of an anti SARS-CoV2 protective immunity</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>purpose of potential ancillary studies using the biological collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creation of COVIDneg and COVID + asymptomatic control groups for other COVID-19 biological collections.</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>purpose of the biological collection that will include people with a negative SRAS-CoV-2 serology and asymptomatic people with a positive SRAS-CoV-2 serology</description>
  </secondary_outcome>
  <enrollment type="Actual">1200</enrollment>
  <condition>COVID-19</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum (12 mL), Plasma (EDTA 12 mL, citrate 7 mL), Peripheral blood mononucleated cells&#xD;
      (PBMC), DNA, RNA, Urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hospital staff agent (medical and non medical) from the &quot;Assistance Publique Hôpitaux de&#xD;
        Paris&quot; undergoing a serology to depict IgG anti SRAS-Cov-2 antibodies in a screening center&#xD;
        from the &quot;Assistance Publique Hôpitaux de Paris&quot; .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospital staff (medical and non-medical)&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
          -  Benefiting from or having benefited 6 months ago from carrying out a SARS-CoV-2&#xD;
             serology by venous sampling on a APHP site as part of monitoring by a screening center&#xD;
&#xD;
          -  Having been informed about the study and having given their informed consent to&#xD;
             participate in the study&#xD;
&#xD;
          -  Beneficiary or entitled to a social security scheme&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
&#xD;
          -  Previously known anemia with hemoglobin &lt;10 g / dL&#xD;
&#xD;
          -  Subject already included in a cohort study with biological collection COVID-19&#xD;
&#xD;
          -  Exclusion period for subjects included or having been included in a COVID-19&#xD;
             interventional study (prophylactic or curative) or other clinical study&#xD;
&#xD;
          -  Subject who received blinded treatment for SARS-Cov-2 in a clinical study&#xD;
&#xD;
          -  Recent COVID-19 compatible infection with D0 of symptoms less than 4 weeks before&#xD;
             collection&#xD;
&#xD;
          -  Subject subject to a judicial protection measure&#xD;
&#xD;
          -  Subject under guardianship or curatorship&#xD;
&#xD;
          -  Subject under state medical aid&#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_official>
    <last_name>Nathalie Dr DEMORY, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AP-HP, Hôpital Européen Georges Pompidou, Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Solen Dr KERNEIS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AP-HP, Hôpital Cochin, Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martine Dr LOUET, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AP-HP, Hôpital la Pitié Salpêtrière, Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bénédicte Dr SAWICKI, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AP-HP, Hôpital Bichat, Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Véronique Dr MAHE, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AP-HP, Hôpital Lariboisière, Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HEGP</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>May 12, 2022</last_update_submitted>
  <last_update_submitted_qc>May 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Serology,</keyword>
  <keyword>Immunity</keyword>
  <keyword>Hospital staff</keyword>
  <keyword>Biobank</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>from february 2021 for the primary outcome and as long as samples will be available in the biological collection.</ipd_time_frame>
    <ipd_access_criteria>Ancillary studies willing to use the biological collection and/or dataset of the COVID-HOP study will be submitted to the scientific board of COVID-HOP for evaluation.&#xD;
Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team.&#xD;
Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization</ipd_access_criteria>
  </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/NCT04418375
org study id: APHP200609
secondary id: APHP200609
secondary id: 2020-A01364-35
nct id: NCT04418375
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the COVID-HOP study is to identify biological and non-biological markers
      associated to: a positive or negative serology anti SRAS-Cov-2; a positive serology and
      having presented symptoms or, on the contrary, not having had symptoms; the persistence of
      immunity or the loss of this immunity over time; the protective nature of the presence of
      anti SRAS-Cov-2 antibodies.

      To answer these questions, a biological collection (serum, plasma, DNA, RNA, mono-nucleated
      cells and urine) and a collection of detailed clinical data during the serological screening
      for SARS-CoV-2 of hospital agents (medical and non-medical staff) of the Assistance Publique
      Hôpitaux de Paris (Paris, France) will be carried out. 4000 professionals in 5 hospitals will
      be included. As part of the research, the anti SRAS-CoV-2 serology will be monitored 6 months
      and 12 months after the initial serology. Numerous studies will be carried out from this
      biological collection and from the database to answer the primary and secondary endpoints.
To answer the questions raised in the primary and secondary endpoints, a biological
      collection (serum, plasma, DNA, RNA, mono-nucleated cells and urine) and a collection of
      detailed data by the mean of a questionnaire (demographic, clinical, lifestyle, professional
      exposure to the virus, COVID-19 infection with detailed symptoms and complications) during
      the serological screening for SARS-CoV-2 of hospital agents (medical and non-medical staff)
      of the Assistance Publique Hôpitaux de Paris (Paris, France) will be carried out. 4000
      professionals in 5 hospitals of the Assistance Publique Hôpitaux de Paris. As part of the
      research, the anti SRAS-CoV-2 serology will be monitored 6 months (M6) and 12 months (M12)
      after the initial serology and a brief questionnaire (update regarding treatments,
      co-morbidities, and COVID-19 infection) will be fulfilled at these two time points. Of note,
      if the inclusion could not be performed during the initial serological screening, the
      professional will be recalled to be included at M6.

      Statistical analysis: The analysis of the determinants independently associated with
      symptomatic COVID + status will be carried out by uni- and multivariate logistic regression.
      The internal validation will be carried out by methods of draw with discount (bootstrap). The
      performance of the model will include calibration (graphical method) and discrimination
      (AUC). The biomarker study will include the study of the association with COVID + symptomatic
      versus asymptomatic status by univariate then multivariate analyzes (logistic regression)
      including clinical variables. The additional value of biomarkers will be studied by comparing
      the discriminating power of clinical models with and without the new biomarker. Finally, the
      study of the heterogeneity of COVID + symptomatic and asymptomatic patients will be carried
      out by an unsupervised analysis of Machine Learning known as archetypes.
observational model: Cohort
time perspective: Prospective
measure: Identification of markers associated with asymptomatic COVID + status (results of the serological test) versus symptomatic COVID + status through a questionnaire (medical history, work environment, lifestyle) and a biological collection
time frame: 12 months
measure: Identification of markers associated with a positive or a negative serology through a questionnaire (medical history, work environment, lifestyle) and a biological collection
time frame: 12 months
measure: Description of the serological status according to the professional risk of exposure to the virus
time frame: 12 months
description: The level of risk of occupational exposure to SARS-CoV-2 will be described in detailed (type of activity during the COVID-19 pandemic, type of protection during this activity...)
measure: Description of the clinical manifestations of COVID-19 infection in hospital professionals
time frame: 12 months
description: All the potential clinical signs of a COVID-19 infection and its complication will be recorded
measure: Identification of risk factors associated with the loss of anti SARS-CoV-2 immunity through a questionnaire (medical history, work environment, lifestyle) and a biological collection
time frame: 12 months
measure: Identification of markers associated with symptomatic COVID-19 infection during follow-up despite the presence of anti SARS-CoV-2 antibodies through a questionnaire (medical history, work environment, lifestyle) and a biological collection
time frame: 12 months
measure: Correlation between the serology result and the PCR result (swabs) for people who have been tested as part of routine care.
time frame: 12 months
description: Correlation between the serology result and the PCR result (swabs) for people who have been tested by PCR as part of routine care.
measure: Identification of potential therapeutic targets to avoid developing a symptomatic form
time frame: Through study completion, an average of 2 years
description: purpose of potential ancillary studies using the biological collection
measure: Identification of potential therapeutic targets to promote the maintenance of an anti SARS-CoV2 protective immunity
time frame: Through study completion, an average of 2 years
description: purpose of potential ancillary studies using the biological collection
measure: Creation of COVIDneg and COVID + asymptomatic control groups for other COVID-19 biological collections.
time frame: Through study completion, an average of 2 years
description: purpose of the biological collection that will include people with a negative SRAS-CoV-2 serology and asymptomatic people with a positive SRAS-CoV-2 serology
Serum (12 mL), Plasma (EDTA 12 mL, citrate 7 mL), Peripheral blood mononucleated cells
      (PBMC), DNA, RNA, Urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nathalie Dr DEMORY, PhD
role: Principal Investigator
affiliation: AP-HP, Hôpital Européen Georges Pompidou, Paris
last name: Solen Dr KERNEIS, PhD
role: Principal Investigator
affiliation: AP-HP, Hôpital Cochin, Paris
last name: Martine Dr LOUET, PhD
role: Principal Investigator
affiliation: AP-HP, Hôpital la Pitié Salpêtrière, Paris
last name: Bénédicte Dr SAWICKI, PhD
role: Principal Investigator
affiliation: AP-HP, Hôpital Bichat, Paris
last name: Véronique Dr MAHE, PhD
role: Principal Investigator
affiliation: AP-HP, Hôpital Lariboisière, Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: from february 2021 for the primary outcome and as long as samples will be available in the biological collection.
ipd access criteria: Ancillary studies willing to use the biological collection and/or dataset of the COVID-HOP study will be submitted to the scientific board of COVID-HOP for evaluation.
Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team.
Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization