<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/NCT04420338</url>
  </required_header>
  <id_info>
    <org_study_id>2020-34</org_study_id>
    <secondary_id>2020-A01515-34</secondary_id>
    <nct_id>NCT04420338</nct_id>
  </id_info>
  <brief_title>SeroCOVIDial Study: Assessment of COVID-19 Seroconversion in Patients on Chronic Hemodialysis and in Their Caregivers, a Cohort Study</brief_title>
  <acronym>SeroCOVIDial</acronym>
  <official_title>SeroCOVIDial Study: Assessment of SARS-COV2 Seroconversion in Patients on Chronic Hemodialysis and in Their Caregivers, 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>
      Background: The preventive containment measures implemented in the COVID-19 pandemic are not&#xD;
      feasible in chronic hemodialysis patients (HD) who need to attend their dialysis sessions 3&#xD;
      times a week. HD patients display frequent comorbidities (such as diabetes and cardiovascular&#xD;
      disease), and immune deficiency, which expose them to an increased risk of severe forms of&#xD;
      COVID-19. They can be infected in their dialysis center despite the measures taken to limit&#xD;
      this risk. Their caregivers are also at risk of infection if patients carry the virus.&#xD;
      Dialysis centers face major organizational challenges in terms of patient and caregiver&#xD;
      safety. Knowing the viral serological status of HD patients and caregivers, the proportion of&#xD;
      asymptomatic forms, and the persistence and effectiveness of immunization over time would be&#xD;
      of major interest for patient management and the organization of dialysis care.&#xD;
&#xD;
      Research objectives: The primary objective of SeroCOVIDial is to assess the prevalence of&#xD;
      SARS-COV2 seroconversion at inclusion (M0) in a cohort of HD patients, using the rapid&#xD;
      serological test. Secondary Objectives : 1) assess the prevalence of SARS-COV2 seroconversion&#xD;
      in dialysis caregivers at M0, using the same test; 2) assess the proportion of asymptomatic&#xD;
      forms of COVID-19 in HD patients and in their caregivers; 3) compare the prevalence of&#xD;
      seroconversion and the proportion of asymptomatic forms in HD patients according to their&#xD;
      clinical characteristics and co-morbidities; 4) assess the prevalence of SARS-COV2&#xD;
      seroconversion in participants who had a documented COVID-19; 5) evaluate the spread of the&#xD;
      epidemic and the kinetics of seroconversion in patients and caregivers by a second test&#xD;
      performed at M3; 6) evaluate the predictive value of SARS-COV2 seroconversion at M0 on the&#xD;
      risk of developing a symptomatic COVID-19 infection within 6 months, in patients and&#xD;
      caregivers; 7) evaluate a posteriori the intrinsic diagnostic performances of the test in&#xD;
      comparison with serological gold standards (ELISA and seroneutralization).&#xD;
&#xD;
      Methods: Multicenter cohort study, carried out in 4 dialysis facilities in Aix-Marseille.&#xD;
&#xD;
      Procedure: collection of clinical data and rapid serological tests carried out at M0 and M3,&#xD;
      in patients and caregivers (a systematic screening for COVID-19 symptoms has been carried out&#xD;
      in all HD patients in the 4 participating centers since the beginning of the pandemic in&#xD;
      France).&#xD;
&#xD;
      Number of participants: 800 eligible persons (561 HD patients, and 239 caregivers). Material&#xD;
      tested: rapid Biosynex serological test on 1 drop of blood, and 1 tube of frozen serum for&#xD;
      patients at M0 and M3. Clinical data will also be collected.&#xD;
&#xD;
      Primary endpoint: prevalence of SARS-COV2 seroconversion in HD patients. Maximum duration of&#xD;
      participation for each patient: 6 months. Duration of research: 6 months and 2 weeks&#xD;
      (inclusions over 2 weeks).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Anticipated">December 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 15, 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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The prevalence of SARS-COV2 seroconversion in chronic hemodialysis patients</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of positive patients out of the total number of patients tested</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The prevalence of SARS-COV2 seroconversion in dialysis caregivers</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion of positive caregivers out of the total number of caregivers tested</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Chronic Hemodialysis Patients</condition>
  <condition>Caregivers of Chronic Hemodialysis Patients</condition>
  <arm_group>
    <arm_group_label>Chronic hemodialysis patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregivers of chronic hemodialysis patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>rapid serological tests carried out</description>
    <arm_group_label>Caregivers of chronic hemodialysis patients</arm_group_label>
    <arm_group_label>Chronic hemodialysis patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Serum tube collection</intervention_name>
    <description>SARS-COV2 seroconversion assay</description>
    <arm_group_label>Chronic hemodialysis patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject of 18 years of age or older&#xD;
&#xD;
          -  Chronic hemodialysis patients or caregiver of chronic hemodialysis patients&#xD;
&#xD;
          -  signed consent&#xD;
&#xD;
          -  Social Security affiliation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Minors&#xD;
&#xD;
          -  Adults under guardianship and trusteeship, persons deprived of their liberty,&#xD;
&#xD;
          -  Participation in a SARS-COV2 vaccine study&#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 ARBAUD, Director</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Philippe BRUNET, PU-PH</last_name>
    <phone>491383042</phone>
    <phone_ext>+33</phone_ext>
    <email>philippe.brunet@ap-hm.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Noémie JOURDE-CHICHE, PU-PH</last_name>
    <phone>491383042</phone>
    <phone_ext>+33</phone_ext>
    <email>Noemie.JOURDE@ap-hm.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <state>Paca</state>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Noémie JOURDE-CHICHE, PU-PH</last_name>
      <phone>491383042</phone>
      <phone_ext>+33</phone_ext>
      <email>Noemie.JOURDE@ap-hm.fr</email>
    </contact>
    <investigator>
      <last_name>Philippe BRUNET, PU-PH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</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/NCT04420338
org study id: 2020-34
secondary id: 2020-A01515-34
nct id: NCT04420338
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: The preventive containment measures implemented in the COVID-19 pandemic are not
      feasible in chronic hemodialysis patients (HD) who need to attend their dialysis sessions 3
      times a week. HD patients display frequent comorbidities (such as diabetes and cardiovascular
      disease), and immune deficiency, which expose them to an increased risk of severe forms of
      COVID-19. They can be infected in their dialysis center despite the measures taken to limit
      this risk. Their caregivers are also at risk of infection if patients carry the virus.
      Dialysis centers face major organizational challenges in terms of patient and caregiver
      safety. Knowing the viral serological status of HD patients and caregivers, the proportion of
      asymptomatic forms, and the persistence and effectiveness of immunization over time would be
      of major interest for patient management and the organization of dialysis care.

      Research objectives: The primary objective of SeroCOVIDial is to assess the prevalence of
      SARS-COV2 seroconversion at inclusion (M0) in a cohort of HD patients, using the rapid
      serological test. Secondary Objectives : 1) assess the prevalence of SARS-COV2 seroconversion
      in dialysis caregivers at M0, using the same test; 2) assess the proportion of asymptomatic
      forms of COVID-19 in HD patients and in their caregivers; 3) compare the prevalence of
      seroconversion and the proportion of asymptomatic forms in HD patients according to their
      clinical characteristics and co-morbidities; 4) assess the prevalence of SARS-COV2
      seroconversion in participants who had a documented COVID-19; 5) evaluate the spread of the
      epidemic and the kinetics of seroconversion in patients and caregivers by a second test
      performed at M3; 6) evaluate the predictive value of SARS-COV2 seroconversion at M0 on the
      risk of developing a symptomatic COVID-19 infection within 6 months, in patients and
      caregivers; 7) evaluate a posteriori the intrinsic diagnostic performances of the test in
      comparison with serological gold standards (ELISA and seroneutralization).

      Methods: Multicenter cohort study, carried out in 4 dialysis facilities in Aix-Marseille.

      Procedure: collection of clinical data and rapid serological tests carried out at M0 and M3,
      in patients and caregivers (a systematic screening for COVID-19 symptoms has been carried out
      in all HD patients in the 4 participating centers since the beginning of the pandemic in
      France).

      Number of participants: 800 eligible persons (561 HD patients, and 239 caregivers). Material
      tested: rapid Biosynex serological test on 1 drop of blood, and 1 tube of frozen serum for
      patients at M0 and M3. Clinical data will also be collected.

      Primary endpoint: prevalence of SARS-COV2 seroconversion in HD patients. Maximum duration of
      participation for each patient: 6 months. Duration of research: 6 months and 2 weeks
      (inclusions over 2 weeks).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The prevalence of SARS-COV2 seroconversion in chronic hemodialysis patients
time frame: 6 months
description: Proportion of positive patients out of the total number of patients tested
measure: The prevalence of SARS-COV2 seroconversion in dialysis caregivers
time frame: 6 months
description: Proportion of positive caregivers out of the total number of caregivers tested
arm group label: Chronic hemodialysis patients
arm group type: Experimental
arm group label: Caregivers of chronic hemodialysis patients
arm group type: Experimental
intervention type: Biological
intervention name: Blood sample
description: rapid serological tests carried out
arm group label: Caregivers of chronic hemodialysis patients
arm group label: Chronic hemodialysis patients
intervention type: Biological
intervention name: Serum tube collection
description: SARS-COV2 seroconversion assay
arm group label: Chronic hemodialysis patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Olivier ARBAUD, Director
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
last name: Philippe BRUNET, PU-PH
phone: 491383042
phone ext: +33
email: philippe.brunet@ap-hm.fr
last name: Noémie JOURDE-CHICHE, PU-PH
phone: 491383042
phone ext: +33
email: Noemie.JOURDE@ap-hm.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
sharing ipd: No