<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/NCT04401085</url>
  </required_header>
  <id_info>
    <org_study_id>UZIS 2020/1</org_study_id>
    <nct_id>NCT04401085</nct_id>
  </id_info>
  <brief_title>COVID-19: Herd Immunity Study in the Czech Republic</brief_title>
  <acronym>SARSCoV2CZPrev</acronym>
  <official_title>Herd Immunity Study SARS-CoV-2-CZ-Preval</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Health Information and Statistics of the Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Palacky University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Masaryk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ostrava</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Faculty of Military Health Sciences, University of Defence in Brno</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Faculty of Health Studies, J. E. Purkyně University in Ústí nad Labem</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute for Clinical and Experimental Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General University Hospital, Prague</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Olomouc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brno University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Krajská zdravotní, a.s., Ústí nad Labem Region Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Military University Hospital, Prague</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Masaryk Memorial Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Czech Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Czech Statistical Office</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Faculty of Medicine in Hradec Králové, Charles University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute of Health Information and Statistics of the Czech Republic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the SARS-CoV-2-CZ-Preval study is to quantify the prevalence of individuals with a&#xD;
      history of SARS-CoV-2 coronavirus infection in the Czech population, except for those&#xD;
      diagnosed with COVID-19 by methods based on direct detection of SARS-CoV- 2, including&#xD;
      individuals with a subclinical course of the disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 is caused by a new type of coronavirus called SARS-CoV-2. It is a highly infectious&#xD;
      disease, manifested mainly by fever, respiratory problems, muscle pain, and fatigue. However,&#xD;
      despite the publication of hundreds of papers in the literature, fundamental information&#xD;
      about the spread and course of the disease is still lacking in COVID-19. One of such key&#xD;
      pieces of information is the prevalence of asymptomatic individuals with SARS-CoV-2&#xD;
      infection, which has a significant effect on the dynamics of the spread of COVID-19 in the&#xD;
      Czech Republic and within individual regions and localities.&#xD;
&#xD;
      The SARS-CoV-2-CZ-Preval study is aiming at quantification of the prevalence of individuals&#xD;
      with a history of SARS-CoV-2 coronavirus infection in the Czech population, except for those&#xD;
      diagnosed with COVID-19 by methods based on direct detection of SARS-CoV- 2, including&#xD;
      individuals with a subclinical course of the disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 23, 2020</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Estimation of the actual prevalence of SARS-CoV-2 positive persons in the Czech Republic.</measure>
    <time_frame>May 2020</time_frame>
    <description>Statistically, the primary objective is formulated as an estimate of the cumulative prevalence of SARS-CoV-2 positive individuals in geographically defined subpopulations of the Czech Republic with declared reliability of +/- 2%. For this primary objective, the required sample size in individual geographical cohorts is calculated. The positivity of SARS-CoV-2 individuals who have not been diagnosed with COVID-19 by a standard route of the detection will be assessed by the presence of specific IgM or IgG antibodies in the blood (antibody tests).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimation of the proportion of people with a subclinical course of the disease</measure>
    <time_frame>May 2020</time_frame>
    <description>The proportion of SARS-CoV-2 positive persons who, according to the questionnaire, will not report any or minimal symptoms in the anamnesis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimation of the cumulative prevalence of the disease and the proportion of people with a subclinical course differences between subcohorts according to demographic, social and clinically relevant stratifications.</measure>
    <time_frame>May 2020</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimation of the proportion of persons suitable for the donation of convalescent plasma</measure>
    <time_frame>May 2020</time_frame>
    <description>The estimation will be calculated according to the prevalence of the disease in the population after excluding contraindications to blood donation (age, health status, etc.).</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">27000</enrollment>
  <condition>COVID</condition>
  <condition>SARS-CoV 2</condition>
  <arm_group>
    <arm_group_label>Population area cohort - Control Cohort</arm_group_label>
    <description>A population cohort of asymptomatic individuals (only adults). This is a representative sample of the population, which are part of the research project of Institute for Clinical and Experimental Medicine and Czech Academy of Sciences. The second subsample included individuals from the official household survey of Czech Statistical Office. This cohort allowed better comparative analysis of other population cohorts from specific geographical areas.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population cohort from specific geographical areas</arm_group_label>
    <description>This cohort is based on epidemiologically defined demographic parameters. These are populations from the following geographical areas:&#xD;
Brno and the South Moravian Region; Praha; Olomouc; Litoměřice; Litovel and Uničov.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronically ill patients cohort</arm_group_label>
    <description>A cohort of chronically ill people enrolled by Institute for Clinical and Experimental Medicine with chronic cardiovascular problems, hypertension, or diabetes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SARS-CoV-2 diagnostic rapid test</intervention_name>
    <description>The rapid test detects the presence of antibodies against SARS-CoV-2 in the IgM and IgG class by the immunochromatographic reaction. It cannot detect early infection, the antibodies will probably appear two weeks after possible infection. The collection will be performed by finger puncture.</description>
    <arm_group_label>Chronically ill patients cohort</arm_group_label>
    <arm_group_label>Population area cohort - Control Cohort</arm_group_label>
    <arm_group_label>Population cohort from specific geographical areas</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Quantitative analysis of SARS-CoV-2 antibodies</intervention_name>
    <description>The subsample from Olomouc region (Olomouc, Uničov, Litovel) is based on venous blood sampling and archiving for subsequent quantitative analysis of SARS-CoV-2 antibodies. These tests detect immunoglobulins M and G (IgM and IgG).</description>
    <arm_group_label>Population cohort from specific geographical areas</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Only in one region, venous blood sampling will be archived in the biobank for subsequent&#xD;
      quantitative analyses.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The population area cohort is chosen based on random selection. The cohort from specific&#xD;
        demographic areas are volunteers from the regions described in the cohort. The population&#xD;
        of chronically ill people is a cohort enrolled by Institute for Clinical and Experimental&#xD;
        Medicine.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signed Informed Consent&#xD;
&#xD;
          -  residing in The Czech Republic&#xD;
&#xD;
          -  demographic criteria: (i) persons aged 8-17 (specific children's cohort), (ii) persons&#xD;
             aged 18-89&#xD;
&#xD;
          -  clinical criteria: (i) without acute health problems (ii) without a confirmed&#xD;
             diagnosis of COVID-19&#xD;
&#xD;
          -  geographic criteria: according to a particular cohort definition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roman Chlíbek, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>University of Defence in Brno</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rastislav Maďar, Assoc. Prof.</last_name>
    <role>Study Director</role>
    <affiliation>University of Ostrava, Faculy of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marián Hajdúch, Assoc. Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Molecular and Translational Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ladislav Dušek, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Health Information and Statistics of the Czech Republic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Roman Prymula, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Ministry of Health, Czech Republic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jarmila Rážová, M.D.; Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Ministry of Health, Czech Republic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Věra Adámková, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Clinical and Experimental Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aleksi Šedo, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charles University, First Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vladimír Černý, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charles University, Faculty of Medicine in Hradec Králové</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jaroslav Štěrba, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brno University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Feltl, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>General University Hospital, Prague</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin Repko, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masaryk University, Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dalibor Valík, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masaryk Memorial Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zdeněk Havel, Assoc. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>J. E. Purkyně University in Ústí nad Labem, Faculty of Health Studies</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Health Information and Statistics of the Czech Republic</name>
      <address>
        <city>Prague</city>
        <zip>128 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>prevalence</keyword>
  <keyword>asymptomatic infection</keyword>
  <keyword>spread dynamics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>It is not yet known if there will be a plan to make IPD available</ipd_description>
  </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/NCT04401085
org study id: UZIS 2020/1
nct id: NCT04401085
lead sponsor: 
collaborator: 
collaborator: 
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collaborator: 
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collaborator: 
collaborator: 
collaborator: 
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collaborator: 
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is fda regulated drug: No
is fda regulated device: No
The aim of the SARS-CoV-2-CZ-Preval study is to quantify the prevalence of individuals with a
      history of SARS-CoV-2 coronavirus infection in the Czech population, except for those
      diagnosed with COVID-19 by methods based on direct detection of SARS-CoV- 2, including
      individuals with a subclinical course of the disease.
COVID-19 is caused by a new type of coronavirus called SARS-CoV-2. It is a highly infectious
      disease, manifested mainly by fever, respiratory problems, muscle pain, and fatigue. However,
      despite the publication of hundreds of papers in the literature, fundamental information
      about the spread and course of the disease is still lacking in COVID-19. One of such key
      pieces of information is the prevalence of asymptomatic individuals with SARS-CoV-2
      infection, which has a significant effect on the dynamics of the spread of COVID-19 in the
      Czech Republic and within individual regions and localities.

      The SARS-CoV-2-CZ-Preval study is aiming at quantification of the prevalence of individuals
      with a history of SARS-CoV-2 coronavirus infection in the Czech population, except for those
      diagnosed with COVID-19 by methods based on direct detection of SARS-CoV- 2, including
      individuals with a subclinical course of the disease.
observational model: Cohort
time perspective: Cross-Sectional
measure: Estimation of the actual prevalence of SARS-CoV-2 positive persons in the Czech Republic.
time frame: May 2020
description: Statistically, the primary objective is formulated as an estimate of the cumulative prevalence of SARS-CoV-2 positive individuals in geographically defined subpopulations of the Czech Republic with declared reliability of +/- 2%. For this primary objective, the required sample size in individual geographical cohorts is calculated. The positivity of SARS-CoV-2 individuals who have not been diagnosed with COVID-19 by a standard route of the detection will be assessed by the presence of specific IgM or IgG antibodies in the blood (antibody tests).
measure: Estimation of the proportion of people with a subclinical course of the disease
time frame: May 2020
description: The proportion of SARS-CoV-2 positive persons who, according to the questionnaire, will not report any or minimal symptoms in the anamnesis.
measure: Estimation of the cumulative prevalence of the disease and the proportion of people with a subclinical course differences between subcohorts according to demographic, social and clinically relevant stratifications.
time frame: May 2020
measure: Estimation of the proportion of persons suitable for the donation of convalescent plasma
time frame: May 2020
description: The estimation will be calculated according to the prevalence of the disease in the population after excluding contraindications to blood donation (age, health status, etc.).
arm group label: Population area cohort - Control Cohort
description: A population cohort of asymptomatic individuals (only adults). This is a representative sample of the population, which are part of the research project of Institute for Clinical and Experimental Medicine and Czech Academy of Sciences. The second subsample included individuals from the official household survey of Czech Statistical Office. This cohort allowed better comparative analysis of other population cohorts from specific geographical areas.
arm group label: Population cohort from specific geographical areas
description: This cohort is based on epidemiologically defined demographic parameters. These are populations from the following geographical areas:
Brno and the South Moravian Region; Praha; Olomouc; Litoměřice; Litovel and Uničov.
arm group label: Chronically ill patients cohort
description: A cohort of chronically ill people enrolled by Institute for Clinical and Experimental Medicine with chronic cardiovascular problems, hypertension, or diabetes.
intervention type: Diagnostic Test
intervention name: SARS-CoV-2 diagnostic rapid test
description: The rapid test detects the presence of antibodies against SARS-CoV-2 in the IgM and IgG class by the immunochromatographic reaction. It cannot detect early infection, the antibodies will probably appear two weeks after possible infection. The collection will be performed by finger puncture.
arm group label: Chronically ill patients cohort
arm group label: Population area cohort - Control Cohort
arm group label: Population cohort from specific geographical areas
intervention type: Diagnostic Test
intervention name: Quantitative analysis of SARS-CoV-2 antibodies
description: The subsample from Olomouc region (Olomouc, Uničov, Litovel) is based on venous blood sampling and archiving for subsequent quantitative analysis of SARS-CoV-2 antibodies. These tests detect immunoglobulins M and G (IgM and IgG).
arm group label: Population cohort from specific geographical areas
Only in one region, venous blood sampling will be archived in the biobank for subsequent
      quantitative analyses.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Roman Chlíbek, Prof.
role: Study Director
affiliation: University of Defence in Brno
last name: Rastislav Maďar, Assoc. Prof.
role: Study Director
affiliation: University of Ostrava, Faculy of Medicine
last name: Marián Hajdúch, Assoc. Prof.
role: Study Director
affiliation: Institute of Molecular and Translational Medicine
last name: Ladislav Dušek, Prof.
role: Study Director
affiliation: Institute of Health Information and Statistics of the Czech Republic
last name: Roman Prymula, Prof.
role: Study Chair
affiliation: Ministry of Health, Czech Republic
last name: Jarmila Rážová, M.D.; Ph.D.
role: Study Chair
affiliation: Ministry of Health, Czech Republic
last name: Věra Adámková, Prof.
role: Principal Investigator
affiliation: Institute for Clinical and Experimental Medicine
last name: Aleksi Šedo, Prof.
role: Principal Investigator
affiliation: Charles University, First Faculty of Medicine
last name: Vladimír Černý, Prof.
role: Principal Investigator
affiliation: Charles University, Faculty of Medicine in Hradec Králové
last name: Jaroslav Štěrba, Prof.
role: Principal Investigator
affiliation: Brno University Hospital
last name: David Feltl, Prof.
role: Principal Investigator
affiliation: General University Hospital, Prague
last name: Martin Repko, Prof.
role: Principal Investigator
affiliation: Masaryk University, Faculty of Medicine
last name: Dalibor Valík, Prof.
role: Principal Investigator
affiliation: Masaryk Memorial Cancer Institute
last name: Zdeněk Havel, Assoc. Prof.
role: Principal Investigator
affiliation: J. E. Purkyně University in Ústí nad Labem, Faculty of Health Studies
facility: 
country: Czechia
responsible party type: Sponsor
mesh term: Antibodies
sharing ipd: Undecided
ipd description: It is not yet known if there will be a plan to make IPD available