<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/NCT04425759</url>
  </required_header>
  <id_info>
    <org_study_id>SERO-MARES (56/20)</org_study_id>
    <nct_id>NCT04425759</nct_id>
  </id_info>
  <brief_title>Prevalence and Risk Factors of SARS-CoV-2 Antibody Responses (COVID-19)</brief_title>
  <acronym>SERO-MARES</acronym>
  <official_title>Prevalence and Risk Factors of SARS-CoV-2 Antibody Responses and Assymptomatic Carriers Among a Cohort of 2,300 Healthcare Workers at the Consorci Sanitari Del Maresme (CSdM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Mataró</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Mataró</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>
      Observational and prospective study with one year of follow-up of the cohort of workers of&#xD;
      the CSdM, including workers of subcontracted companies working in the Hospital of Mataró&#xD;
      (2,300 workers approximately) and with controls at baseline and at 3, 6, 9 and 12 months. All&#xD;
      CSdM workers will be invited to participate by e-mail and by announcements in the corporate&#xD;
      website. A space will be set up on the corporate intranet where workers will be informed&#xD;
      about the study, will be able to give their informed consent and will be able to answer an&#xD;
      electronic questionnaire regarding socio-demographic, clinical and labour personal&#xD;
      characteristics. Once the questionnaire answered, participants will be authorized to schedule&#xD;
      a blood extraction. Prevalence of antibodies against SARS-CoV-2 will be analyzed (IgA, IgM,&#xD;
      IgG). PCR will be also performed for IgM and IgA positive subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Study design: observational and prospective study with one year of follow-up of the&#xD;
           cohort of workers of the CSdM, including workers of subcontracted companies working in&#xD;
           the Hospital of Mataró (2,300 workers approximately) and with controls at baseline and&#xD;
           at 3, 6, 9 and 12 months.&#xD;
&#xD;
        -  Aims: to perform a universal test for all the professionals of the Consorci Sanitari del&#xD;
           Maresme (CSdM) in order to carry out the following objectives:&#xD;
&#xD;
             1. Let them know if they have been exposed to the SARS-CoV-2 virus.&#xD;
&#xD;
             2. Identify asymptomatic carriers of SARS-CoV-2 virus.&#xD;
&#xD;
             3. Develop an immune map of all the professionals to: a) describe the seroprevalence&#xD;
                of SARS-CoV-2 antibodies and their evolution over a year; b) help minimize the risk&#xD;
                of infection in CSdM professionals; c) contribute to the improvement of knowledge&#xD;
                about the infection and the social and occupational factors that affect its spread;&#xD;
                and d) allow in the future to identify the duration of immunity against SARS-CoV-2.&#xD;
&#xD;
        -  Time Frame: 1 year.&#xD;
&#xD;
        -  Study population: all workers from the healthcare centers of the Consorci Sanitari del&#xD;
           Maresme will be invited to participate by e-mail and by announcements in the corporate&#xD;
           website. A space will be set up on the corporate intranet where workers will be informed&#xD;
           about the study, will be able to give their informed consent and will be able to answer&#xD;
           an electronic questionnaire regarding socio-demographic, clinical and labour personal&#xD;
           characteristics. Once the questionnaire answered, participants will be authorized to&#xD;
           schedule a blood extraction.&#xD;
&#xD;
        -  Methods: Prevalence of antibodies against SARS-CoV-2 will be analyzed (IgA, IgM, IgG)&#xD;
           and PCR will be also performed for IgM and IgA positive subjects following this&#xD;
           algorithm:&#xD;
&#xD;
      Serological study:&#xD;
&#xD;
        1. Screening the entire population with total CLIA result (IgA, IgM, IgG) to determine&#xD;
           negatives.&#xD;
&#xD;
        2. ELISA for positives with differentiated IgM, IgA and IgG results.&#xD;
&#xD;
        3. PCR of nasopharyngeal smears on all IgM and IgA + (to determine asymptomatic cases).&#xD;
&#xD;
      There will be other blood samplings and determination points at 3, 6, 9 and 12 months for all&#xD;
      the study participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</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>1 Year</target_duration>
  <primary_outcome>
    <measure>Antibodies to SARS-CoV2: IgA, IgM, IgG</measure>
    <time_frame>1 year</time_frame>
    <description>Screening for the entire population with total IgA, IgM, IgG to screen the negatives&#xD;
ELISA for positives with differentiated IgM+IgA vs IgG specific for SARS-Cov-2 seroprevalence of SARS-CoV-2 antibodies and their evolution over a year; b) help minimize the risk of infection in CSdM professionals; c) contribute to the improvement of knowledge about the infection and the social and occupational factors that affect its spread; and d) allow in the future to identify the duration of immunity against SARS-CoV-2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PCR of nasopharyngeal smears on all IgM +</measure>
    <time_frame>1 year</time_frame>
    <description>To detect symptomatic or asymptomatic carriers&#xD;
New diagnostics of COVID19 confirmed by PCR of nasopharyngeal smears</description>
  </primary_outcome>
  <enrollment type="Anticipated">2400</enrollment>
  <condition>Covid19</condition>
  <condition>Corona Virus Infection</condition>
  <condition>SARS-CoV 2</condition>
  <condition>COVID</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>Blood sammples for the serological analysis will be collected at 0/90/180/270/360 days.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Professionals working at the Maresme Health Consortium (CSdM).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All the professionals working at the Consorci Sanitari del Maresme (approximately 2300&#xD;
             subjects).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None.&#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>Pere Clavé, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Mataró</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pere Clavé, MD, PhD</last_name>
    <phone>+34937417700</phone>
    <phone_ext>1046</phone_ext>
    <email>pere.clave@ciberehd.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital de Mataró</name>
      <address>
        <city>Mataró</city>
        <state>Barcelona</state>
        <zip>08304</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pere Clavé, MD</last_name>
      <phone>937417700</phone>
      <phone_ext>2285</phone_ext>
      <email>pere.clave@ciberehd.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Mataró</investigator_affiliation>
    <investigator_full_name>Pere Clave</investigator_full_name>
    <investigator_title>Director of Research and Academic Development at CSdM</investigator_title>
  </responsible_party>
  <keyword>COVID</keyword>
  <keyword>ANTIBODY</keyword>
  <keyword>SARS-COV2</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <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/NCT04425759
org study id: SERO-MARES (56/20)
nct id: NCT04425759
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational and prospective study with one year of follow-up of the cohort of workers of
      the CSdM, including workers of subcontracted companies working in the Hospital of Mataró
      (2,300 workers approximately) and with controls at baseline and at 3, 6, 9 and 12 months. All
      CSdM workers will be invited to participate by e-mail and by announcements in the corporate
      website. A space will be set up on the corporate intranet where workers will be informed
      about the study, will be able to give their informed consent and will be able to answer an
      electronic questionnaire regarding socio-demographic, clinical and labour personal
      characteristics. Once the questionnaire answered, participants will be authorized to schedule
      a blood extraction. Prevalence of antibodies against SARS-CoV-2 will be analyzed (IgA, IgM,
      IgG). PCR will be also performed for IgM and IgA positive subjects.
-  Study design: observational and prospective study with one year of follow-up of the
           cohort of workers of the CSdM, including workers of subcontracted companies working in
           the Hospital of Mataró (2,300 workers approximately) and with controls at baseline and
           at 3, 6, 9 and 12 months.

        -  Aims: to perform a universal test for all the professionals of the Consorci Sanitari del
           Maresme (CSdM) in order to carry out the following objectives:

             1. Let them know if they have been exposed to the SARS-CoV-2 virus.

             2. Identify asymptomatic carriers of SARS-CoV-2 virus.

             3. Develop an immune map of all the professionals to: a) describe the seroprevalence
                of SARS-CoV-2 antibodies and their evolution over a year; b) help minimize the risk
                of infection in CSdM professionals; c) contribute to the improvement of knowledge
                about the infection and the social and occupational factors that affect its spread;
                and d) allow in the future to identify the duration of immunity against SARS-CoV-2.

        -  Time Frame: 1 year.

        -  Study population: all workers from the healthcare centers of the Consorci Sanitari del
           Maresme will be invited to participate by e-mail and by announcements in the corporate
           website. A space will be set up on the corporate intranet where workers will be informed
           about the study, will be able to give their informed consent and will be able to answer
           an electronic questionnaire regarding socio-demographic, clinical and labour personal
           characteristics. Once the questionnaire answered, participants will be authorized to
           schedule a blood extraction.

        -  Methods: Prevalence of antibodies against SARS-CoV-2 will be analyzed (IgA, IgM, IgG)
           and PCR will be also performed for IgM and IgA positive subjects following this
           algorithm:

      Serological study:

        1. Screening the entire population with total CLIA result (IgA, IgM, IgG) to determine
           negatives.

        2. ELISA for positives with differentiated IgM, IgA and IgG results.

        3. PCR of nasopharyngeal smears on all IgM and IgA + (to determine asymptomatic cases).

      There will be other blood samplings and determination points at 3, 6, 9 and 12 months for all
      the study participants.
observational model: Cohort
time perspective: Prospective
measure: Antibodies to SARS-CoV2: IgA, IgM, IgG
time frame: 1 year
description: Screening for the entire population with total IgA, IgM, IgG to screen the negatives
ELISA for positives with differentiated IgM+IgA vs IgG specific for SARS-Cov-2 seroprevalence of SARS-CoV-2 antibodies and their evolution over a year; b) help minimize the risk of infection in CSdM professionals; c) contribute to the improvement of knowledge about the infection and the social and occupational factors that affect its spread; and d) allow in the future to identify the duration of immunity against SARS-CoV-2.
measure: PCR of nasopharyngeal smears on all IgM +
time frame: 1 year
description: To detect symptomatic or asymptomatic carriers
New diagnostics of COVID19 confirmed by PCR of nasopharyngeal smears
intervention type: Diagnostic Test
intervention name: Blood sample
description: Blood sammples for the serological analysis will be collected at 0/90/180/270/360 days.
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: Pere Clavé, MD, PhD
role: Principal Investigator
affiliation: Hospital de Mataró
last name: Pere Clavé, MD, PhD
phone: +34937417700
phone ext: 1046
email: pere.clave@ciberehd.org
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital de Mataró
investigator full name: Pere Clave
investigator title: Director of Research and Academic Development at CSdM
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: No