<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/NCT04406038</url>
  </required_header>
  <id_info>
    <org_study_id>CDRU-001</org_study_id>
    <nct_id>NCT04406038</nct_id>
  </id_info>
  <brief_title>Study of the Spread of COVID-19 in Saint Petersburg, Russia</brief_title>
  <official_title>A Population-Based Seroprevalence of SARS-CoV-2-Specific Antibodies Among Adults in Saint Petersburg, Russia: Longitudinal Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European University at St. Petersburg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European University at St. Petersburg</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>
      Seroprevalence study of COVID-19 in Saint Petersburg, Russia is a regional longitudinal&#xD;
      cohort study aiming to evaluate the spread dynamics of the COVID-19 disease in the population&#xD;
      of Saint Petersburg. Clinically asymptomatic adults are sampled from the population using&#xD;
      random digit dialing and tested for the presence of SARS-CoV-2-specific antibodies in the&#xD;
      blood serum. Data collection and serial sampling of the same individuals spans four weeks and&#xD;
      is conducted every two weeks in order to understand both the spread of the virus in the&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At least 1 000 individuals, 18 years old and older, are randomly sampled using random digit&#xD;
      dialing from the population of Saint Petersburg, Russia. Random sampling is performed by a&#xD;
      survey company on the list of mobile phone numbers with designated geography prefixes of St.&#xD;
      Petersburg. The baseline questionnaire for computer-assisted telephone interview includes&#xD;
      travel history, medical history, and socio-economic status of the respondents. Sampled&#xD;
      individuals are then invited to the clinic for blood sampling, their refusal to participate&#xD;
      is recorded. Collected blood samples are used for SARS-CoV-2-specific antibodies testing.&#xD;
      Data and sample collection spans four weeks and is conducted every two weeks. Participants&#xD;
      complete additional questionnaires in the clinic providing information on medical history,&#xD;
      history of allergies, chronic disease, smoking, and medication taken regularly. Contact&#xD;
      tracing data and environmental conditions of the household are reсorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 27, 2020</start_date>
  <completion_date type="Anticipated">October 28, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 28, 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>Prevalence of the SARS-COV-2 infection in Saint Petersburg, Russia</measure>
    <time_frame>Measured with two-week (14 days) intervals</time_frame>
    <description>Measured by SARS-CoV-2-specific antibodies serial testing and corrected for volunteer bias and test characteristics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence odds ratios</measure>
    <time_frame>Measured with two-week (14 days) intervals</time_frame>
    <description>Comparison of prevalence by age, sex and socioeconomic strata.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune response dynamics</measure>
    <time_frame>Measured with two-week (14 days) intervals</time_frame>
    <description>Seropositivity, seroreversion and seroconversion.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1038</enrollment>
  <condition>COVID19</condition>
  <arm_group>
    <arm_group_label>Healthy adults</arm_group_label>
    <description>Healthy adults randomly sampled from the population of Saint Petersburg</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Representative sample of the population of Saint Petersburg, Russia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals sampled from the population of Saint Petersburg, Russia using random digit&#xD;
             dialling.&#xD;
&#xD;
          -  Subjects aged 18 and older of both genders.&#xD;
&#xD;
          -  Asymptomatic at the time of blood draw.&#xD;
&#xD;
          -  Written informed consent for a blood draw, SARS-COV-2 antibody test, and data&#xD;
             collection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of fever or cough or respiratory distress at the time of blood test not&#xD;
             attributable to other known chronic disease.&#xD;
&#xD;
          -  Age under 18.&#xD;
&#xD;
          -  Any health condition that may be a contraindication towards blood sampling in&#xD;
             out-patient clinic.&#xD;
&#xD;
          -  Residence in Kolpinskiy, Kurortniy, Krasnoselsky, Kronshtadtskiy, Petrodvorcoviy,&#xD;
             Pushkinskiy districts of St. Petersburg.&#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>Lubov Barabanova, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinic &quot;Scandinavia&quot;</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinic &quot;Scandinavia&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>196084</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 28, 2022</last_update_submitted>
  <last_update_submitted_qc>July 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>seroprevalence</keyword>
  <keyword>covid-19</keyword>
  <keyword>sars-cov-2</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_description>Anonymized individual phone survey data, anonymized paper-based survey data, test results, and analytic code are available in a designated repository (see the URL below).</ipd_description>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Currently available and for indefinite period</ipd_time_frame>
    <ipd_access_criteria>Creative Commons License Attribution 4.0 International (CC BY 4.0)</ipd_access_criteria>
    <ipd_url>https://github.com/eusporg/spb_covid_study20</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 15, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT04406038/Prot_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04406038
org study id: CDRU-001
nct id: NCT04406038
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Seroprevalence study of COVID-19 in Saint Petersburg, Russia is a regional longitudinal
      cohort study aiming to evaluate the spread dynamics of the COVID-19 disease in the population
      of Saint Petersburg. Clinically asymptomatic adults are sampled from the population using
      random digit dialing and tested for the presence of SARS-CoV-2-specific antibodies in the
      blood serum. Data collection and serial sampling of the same individuals spans four weeks and
      is conducted every two weeks in order to understand both the spread of the virus in the
      population.
At least 1 000 individuals, 18 years old and older, are randomly sampled using random digit
      dialing from the population of Saint Petersburg, Russia. Random sampling is performed by a
      survey company on the list of mobile phone numbers with designated geography prefixes of St.
      Petersburg. The baseline questionnaire for computer-assisted telephone interview includes
      travel history, medical history, and socio-economic status of the respondents. Sampled
      individuals are then invited to the clinic for blood sampling, their refusal to participate
      is recorded. Collected blood samples are used for SARS-CoV-2-specific antibodies testing.
      Data and sample collection spans four weeks and is conducted every two weeks. Participants
      complete additional questionnaires in the clinic providing information on medical history,
      history of allergies, chronic disease, smoking, and medication taken regularly. Contact
      tracing data and environmental conditions of the household are reсorded.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of the SARS-COV-2 infection in Saint Petersburg, Russia
time frame: Measured with two-week (14 days) intervals
description: Measured by SARS-CoV-2-specific antibodies serial testing and corrected for volunteer bias and test characteristics.
measure: Prevalence odds ratios
time frame: Measured with two-week (14 days) intervals
description: Comparison of prevalence by age, sex and socioeconomic strata.
measure: Immune response dynamics
time frame: Measured with two-week (14 days) intervals
description: Seropositivity, seroreversion and seroconversion.
arm group label: Healthy adults
description: Healthy adults randomly sampled from the population of Saint Petersburg
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lubov Barabanova, MD
role: Principal Investigator
affiliation: Clinic "Scandinavia"
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes
ipd description: Anonymized individual phone survey data, anonymized paper-based survey data, test results, and analytic code are available in a designated repository (see the URL below).
ipd info type: Analytic Code
ipd time frame: Currently available and for indefinite period
ipd access criteria: Creative Commons License Attribution 4.0 International (CC BY 4.0)
ipd url: https://github.com/eusporg/spb_covid_study20
provided document: 