<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/NCT04453280</url>
  </required_header>
  <id_info>
    <org_study_id>UZIS 2020/2</org_study_id>
    <nct_id>NCT04453280</nct_id>
  </id_info>
  <brief_title>Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)</brief_title>
  <acronym>SARSCoV2CZImun</acronym>
  <official_title>Antibody Detection in COVID-19 Cured Patients (SARS-CoV-2-CZ-Immunity)</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>Masaryk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute for Clinical and Experimental Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brno University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Anne's University Hospital Brno, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Masaryk Memorial Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Regional Public Health Office of the South Moravian Region based in Brno, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Public Health Office of the Capital City of Prague, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Regional Public Health Office of the Central Bohemian Region based in Prague, Czech Republic</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-Immunity study is to determine the time profile of the presence&#xD;
      of antibodies against SARS-CoV-2 in blood plasma by quantification of antibodies or&#xD;
      performing a rapid test in COVID-19 cured patients.&#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;
      information is the time profile of the presence of antibodies against SARS-CoV-2 after the&#xD;
      disease.&#xD;
&#xD;
      The SARS-CoV-2-CZ-Immunity study is aiming at the determination of the time profile of the&#xD;
      presence of antibodies against SARS-CoV-2 in blood plasma by quantification of antibodies or&#xD;
      performing a rapid test in COVID-19 cured patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 18, 2020</start_date>
  <completion_date type="Actual">June 3, 2020</completion_date>
  <primary_completion_date type="Actual">June 3, 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>Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the categories of cured patients.</measure>
    <time_frame>May 2020</time_frame>
    <description>The primary outcome is the determination of the concentration of anti-SARS-CoV-2 antibodies IgG, IgM, and IgA classes in relation to the categories of cured patients according to the time from the date of cure from the COVID-19 disease to the date of examination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the age and to the severity of the disease.</measure>
    <time_frame>June 2020</time_frame>
    <description>The determination of the concentration of anti-SARS-CoV-2 antibodies IgG, IgM, and IgA classes in relation to the categories of cured patients according to their age: category 8-17, 18-39, 40-59, 60 and more years and according to the severity of the disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The quantification of the dependence of the change in the concentration of anti-SARS-CoV-2 antibodies.</measure>
    <time_frame>June 2020</time_frame>
    <description>The quantification of the dependence of the change in the concentration of anti-SARS-CoV-2 antibodies IgG, IgM, and IgA classes on the time since cure (analysis by statistical model)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The identification of potential donors of convalescent plasma.</measure>
    <time_frame>June2020</time_frame>
    <description>The identification of individuals in the study population, who can be contacted as voluntary donors of convalescent plasma, which is one of the therapeutic modalities in patients with severe COVID-19 disease.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">695</enrollment>
  <condition>COVID</condition>
  <condition>SARS-CoV-2</condition>
  <arm_group>
    <arm_group_label>Cohort 1 - Prague and Central Bohemian Region</arm_group_label>
    <description>A population cohort of cured patients based on epidemiologically defined demographic parameters - Prague and Central Bohemian Region population</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 - South Moravian Region</arm_group_label>
    <description>A population cohort of cured patients based on epidemiologically defined demographic parameters - South Moravian Region population.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Quantitative analysis of anti-SARS-CoV-2-antibodies</intervention_name>
    <description>Plasma sampling will be collected and archived for subsequent quantitative analysis of anti-SARS-CoV-2 antibodies - IgG, IgM and IgA.</description>
    <arm_group_label>Cohort 1 - Prague and Central Bohemian Region</arm_group_label>
    <arm_group_label>Cohort 2 - South Moravian Region</arm_group_label>
  </intervention>
  <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 by the immunochromatographic reaction.</description>
    <arm_group_label>Cohort 1 - Prague and Central Bohemian Region</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood plasma sampling will be archived in the biobank for subsequent quantitative analyses.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Both cohorts will be selected from all actually cured individuals from specific demographic&#xD;
        areas described in the cohorts. The cohorts of people will be addressed by Public Health&#xD;
        Office.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signed Informed Consent&#xD;
&#xD;
          -  residing in Prague, Central Bohemian Region or South Moravian Region&#xD;
&#xD;
          -  demographic criteria: persons aged 8-17 and persons aged 18 and more&#xD;
&#xD;
          -  clinical criteria: (i) diagnosis of COVID-19 confirmed by PCR (ii) cured patients:&#xD;
             clearance of SARS-CoV-2 viral RNA demonstrated by two consecutive negative RT-PCR&#xD;
             results (iii) without acute health problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roman Prymula, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ministry of Health, Czech Republic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jarmila Rážová, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ministry of Health, Czech Republic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ladislav Dušek, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Health Information and Statistics of the Czech Republic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dalibor Valík, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masaryk Memorial Cancer Institute</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>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>antibody</keyword>
  <keyword>humoral immunity</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/NCT04453280
org study id: UZIS 2020/2
nct id: NCT04453280
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of the SARS-CoV-2-CZ-Immunity study is to determine the time profile of the presence
      of antibodies against SARS-CoV-2 in blood plasma by quantification of antibodies or
      performing a rapid test in COVID-19 cured patients.
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
      information is the time profile of the presence of antibodies against SARS-CoV-2 after the
      disease.

      The SARS-CoV-2-CZ-Immunity study is aiming at the determination of the time profile of the
      presence of antibodies against SARS-CoV-2 in blood plasma by quantification of antibodies or
      performing a rapid test in COVID-19 cured patients.
observational model: Cohort
time perspective: Cross-Sectional
measure: Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the categories of cured patients.
time frame: May 2020
description: The primary outcome is the determination of the concentration of anti-SARS-CoV-2 antibodies IgG, IgM, and IgA classes in relation to the categories of cured patients according to the time from the date of cure from the COVID-19 disease to the date of examination.
measure: Determination of the concentration of anti-SARS-CoV-2 antibodies in relation to the age and to the severity of the disease.
time frame: June 2020
description: The determination of the concentration of anti-SARS-CoV-2 antibodies IgG, IgM, and IgA classes in relation to the categories of cured patients according to their age: category 8-17, 18-39, 40-59, 60 and more years and according to the severity of the disease.
measure: The quantification of the dependence of the change in the concentration of anti-SARS-CoV-2 antibodies.
time frame: June 2020
description: The quantification of the dependence of the change in the concentration of anti-SARS-CoV-2 antibodies IgG, IgM, and IgA classes on the time since cure (analysis by statistical model)
measure: The identification of potential donors of convalescent plasma.
time frame: June2020
description: The identification of individuals in the study population, who can be contacted as voluntary donors of convalescent plasma, which is one of the therapeutic modalities in patients with severe COVID-19 disease.
arm group label: Cohort 1 - Prague and Central Bohemian Region
description: A population cohort of cured patients based on epidemiologically defined demographic parameters - Prague and Central Bohemian Region population
arm group label: Cohort 2 - South Moravian Region
description: A population cohort of cured patients based on epidemiologically defined demographic parameters - South Moravian Region population.
intervention type: Diagnostic Test
intervention name: Quantitative analysis of anti-SARS-CoV-2-antibodies
description: Plasma sampling will be collected and archived for subsequent quantitative analysis of anti-SARS-CoV-2 antibodies - IgG, IgM and IgA.
arm group label: Cohort 1 - Prague and Central Bohemian Region
arm group label: Cohort 2 - South Moravian Region
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 by the immunochromatographic reaction.
arm group label: Cohort 1 - Prague and Central Bohemian Region
Blood plasma 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: N/A
healthy volunteers: No
last name: Roman Prymula, Prof.
role: Principal Investigator
affiliation: Ministry of Health, Czech Republic
last name: Jarmila Rážová, M.D., Ph.D.
role: Principal Investigator
affiliation: Ministry of Health, Czech Republic
last name: Ladislav Dušek, Prof.
role: Principal Investigator
affiliation: Institute of Health Information and Statistics of the Czech Republic
last name: Dalibor Valík, Prof.
role: Principal Investigator
affiliation: Masaryk Memorial Cancer Institute
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.