<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/NCT04429620</url>
  </required_header>
  <id_info>
    <org_study_id>SARS-CoV-2-IIF-002</org_study_id>
    <nct_id>NCT04429620</nct_id>
  </id_info>
  <brief_title>Prospective Assay for SARS-CoV-2 (COVID-19) Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method</brief_title>
  <acronym>IIF</acronym>
  <official_title>Prospective Assay for SARS-CoV-2 Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Szeged University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bilogical Research Centre, Szeged</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Szeged University</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>
      Prospective assay for SARS-CoV-2 antibody detection indirectly by immunofluorescence:&#xD;
      SARS-CoV2 IIF method&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sample preparation, serum separation by centrifugation&#xD;
&#xD;
        -  100 µl of serum for standard SARS-CoV2 ELISA is used according to the instructions for&#xD;
           use.&#xD;
&#xD;
        -  100 µl of serum indirect immunofluorescent (IIF) method is used, the samples thus&#xD;
           prepared analysis is performed under an automated microscope&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 30, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity of the method by SARS-CoV2 ELISA compared</measure>
    <time_frame>8 months</time_frame>
    <description>Sensitivity of the method by SARS-CoV2 ELISA compared</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detectability of the antibodies IgA type against SARS-CoV2 virus</measure>
    <time_frame>8 months</time_frame>
    <description>Detectability of the antibodies IgA type against SARS-CoV2 virus in the early stages of the disease.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Sars-CoV2</condition>
  <arm_group>
    <arm_group_label>Positive group</arm_group_label>
    <description>Subjects are diagnosed with SARS-CoV2 by qPCR assay.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative group</arm_group_label>
    <description>Subject were 2 times proved negative SARS-CoV2 by qPCR assay.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Immunfluorescence</intervention_name>
    <description>Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.</description>
    <arm_group_label>Negative group</arm_group_label>
    <arm_group_label>Positive group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults, Hungarian&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Person over 18 years of age&#xD;
&#xD;
          -  Signing a package leaflet and a informal consent&#xD;
&#xD;
          -  In the case of a positive group, confirmed by SARS-CoV2 qPCR Patient with COVID-19 or&#xD;
             recovered individual.&#xD;
&#xD;
          -  In case of negative group by SARS-CoV2 qPCR test 2 negative in COVID-19 suffering&#xD;
             individual&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refuses to sign the consent form&#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>Katalin Burián, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Szeged, Institute of Clinical Microbilogy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katalin Burián, MD</last_name>
    <phone>+36 62 544 000</phone>
    <email>burian.katalin@med.u-szeged.hu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dávid Pintér, Pharm. D.</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Szeged, Albert Szent-Györgyi Health Center</name>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katalin Burián, MD</last_name>
      <phone>+36 62 544 000</phone>
    </contact>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <link>
    <url>https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases</url>
    <description>COVID-19 situation update worldwide</description>
  </link>
  <link>
    <url>https://www.worldometers.info/coronavirus/country/italy/</url>
    <description>COVID-19 CORONAVIRUS PANDEMIC</description>
  </link>
  <link>
    <url>https://www.medrxiv.org/content/10.1101/2020.03.17.20037713v1.full.pdf</url>
    <description>A serological assay to detect SARS-CoV-2 seroconversion in humans</description>
  </link>
  <link>
    <url>https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2020.25.11.2000266</url>
    <description>Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland, January to February 2020</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 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/NCT04429620
org study id: SARS-CoV-2-IIF-002
nct id: NCT04429620
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective assay for SARS-CoV-2 antibody detection indirectly by immunofluorescence:
      SARS-CoV2 IIF method
Sample preparation, serum separation by centrifugation

        -  100 µl of serum for standard SARS-CoV2 ELISA is used according to the instructions for
           use.

        -  100 µl of serum indirect immunofluorescent (IIF) method is used, the samples thus
           prepared analysis is performed under an automated microscope
observational model: Case-Control
time perspective: Other
measure: Sensitivity of the method by SARS-CoV2 ELISA compared
time frame: 8 months
description: Sensitivity of the method by SARS-CoV2 ELISA compared
measure: Detectability of the antibodies IgA type against SARS-CoV2 virus
time frame: 8 months
description: Detectability of the antibodies IgA type against SARS-CoV2 virus in the early stages of the disease.
arm group label: Positive group
description: Subjects are diagnosed with SARS-CoV2 by qPCR assay.
arm group label: Negative group
description: Subject were 2 times proved negative SARS-CoV2 by qPCR assay.
intervention type: Diagnostic Test
intervention name: Immunfluorescence
description: Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.
arm group label: Negative group
arm group label: Positive group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katalin Burián, MD
role: Principal Investigator
affiliation: University of Szeged, Institute of Clinical Microbilogy
last name: Katalin Burián, MD
phone: +36 62 544 000
email: burian.katalin@med.u-szeged.hu
last name: Dávid Pintér, Pharm. D.
facility: 
status: Recruiting
contact: 
country: Hungary
url: https://www.ecdc.europa.eu/en/geographical-distribution-2019-ncov-cases
description: COVID-19 situation update worldwide
url: https://www.worldometers.info/coronavirus/country/italy/
description: COVID-19 CORONAVIRUS PANDEMIC
url: https://www.medrxiv.org/content/10.1101/2020.03.17.20037713v1.full.pdf
description: A serological assay to detect SARS-CoV-2 seroconversion in humans
url: https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2020.25.11.2000266
description: Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland, January to February 2020
responsible party type: Sponsor
sharing ipd: No