<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/NCT04483622</url>
  </required_header>
  <id_info>
    <org_study_id>IBR#S20-133</org_study_id>
    <nct_id>NCT04483622</nct_id>
  </id_info>
  <brief_title>Immunoglobulin G Antibody Immune Response Profile Following Infection With SARS-CoV-2 in COVID-19 Egyptian Patients</brief_title>
  <acronym>COVID-19</acronym>
  <official_title>Immunoglobulin G Antibody Immune Response Profile Following Infection With SARS-CoV-2 in COVID-19 Egyptian Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sohag University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sohag 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>
      The objective of this study is to detect the evidence on the immune response following acute&#xD;
      SARS-CoV-2 infections. the study will report the profile of IgG specific antibodies levels to&#xD;
      SARS-CoV-2 infection found in recovered coronavirus disease (COVID-19) patients after&#xD;
      infection for both symptomatic and asymptomatic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 30 COVID-19 patients for the study will be enrolled. All the patients enrolled&#xD;
      were confirmed to be infected with SARS-CoV-2 by RT-PCR assay for nasal and pharyngeal swab&#xD;
      specimens.&#xD;
&#xD;
      For the study, serum samples of the 30 patients will be collected and will be investigated&#xD;
      for the detection rate for immunoglobulin G (IgG). The first sample will be collected 2 weeks&#xD;
      after the second negative RT-PCR assay for nasal and pharyngeal swab specimens and 6 samples&#xD;
      will be collected after that for 6 months later; one serum sample tested every month for 6&#xD;
      months after.&#xD;
&#xD;
      The following questions will be addressed:-&#xD;
&#xD;
        1. What proportion of confirmed cases develops specific IgG antibodies to SARS-CoV-2?&#xD;
&#xD;
        2. How long is the duration of detection of serum IgG antibodies and antibody titres over&#xD;
           time following infection with SARS-CoV-2?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2020</start_date>
  <completion_date type="Actual">December 25, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>rising titre of IGg antibodies</measure>
    <time_frame>first month</time_frame>
    <description>it's expected to have COVID-19 antibodies within 1month of infection the antibody titre expected to rise the fall to a lower levels</description>
  </primary_outcome>
  <enrollment type="Actual">33</enrollment>
  <condition>Covid19</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients attending sohag university hospital and have recent COVID -19 infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with recent COVID- 19 infection(2 weeks after the second negative RT-PCR&#xD;
             assay)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients on immune-suppressive therapy&#xD;
&#xD;
          -  patients with immunological disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sohag University Hospital</name>
      <address>
        <city>Sohag</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>May 10, 2022</last_update_submitted>
  <last_update_submitted_qc>May 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sohag University</investigator_affiliation>
    <investigator_full_name>Asmaa Mohamed Goda</investigator_full_name>
    <investigator_title>assistant professor of medical microbiology and immunology at sohag faculty of medicine fa</investigator_title>
  </responsible_party>
  <keyword>COVID19 IGg</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>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/NCT04483622
org study id: IBR#S20-133
nct id: NCT04483622
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to detect the evidence on the immune response following acute
      SARS-CoV-2 infections. the study will report the profile of IgG specific antibodies levels to
      SARS-CoV-2 infection found in recovered coronavirus disease (COVID-19) patients after
      infection for both symptomatic and asymptomatic patients.
A total of 30 COVID-19 patients for the study will be enrolled. All the patients enrolled
      were confirmed to be infected with SARS-CoV-2 by RT-PCR assay for nasal and pharyngeal swab
      specimens.

      For the study, serum samples of the 30 patients will be collected and will be investigated
      for the detection rate for immunoglobulin G (IgG). The first sample will be collected 2 weeks
      after the second negative RT-PCR assay for nasal and pharyngeal swab specimens and 6 samples
      will be collected after that for 6 months later; one serum sample tested every month for 6
      months after.

      The following questions will be addressed:-

        1. What proportion of confirmed cases develops specific IgG antibodies to SARS-CoV-2?

        2. How long is the duration of detection of serum IgG antibodies and antibody titres over
           time following infection with SARS-CoV-2?
observational model: Case-Only
time perspective: Prospective
measure: rising titre of IGg antibodies
time frame: first month
description: it's expected to have COVID-19 antibodies within 1month of infection the antibody titre expected to rise the fall to a lower levels
serum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Sohag University
investigator full name: Asmaa Mohamed Goda
investigator title: assistant professor of medical microbiology and immunology at sohag faculty of medicine fa
mesh term: COVID-19
sharing ipd: No