<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/NCT04462120</url>
  </required_header>
  <id_info>
    <org_study_id>AssiutU15</org_study_id>
    <nct_id>NCT04462120</nct_id>
  </id_info>
  <brief_title>IL-12RB and TNF-alpha Gene Polymorphism and Susceptibility and Progress of Covid-19 SARS-CoV-2: A Case Control Study</brief_title>
  <official_title>Association Between IL-12RB and TNF-alpha Gene Polymorphism With Susceptibility and Progress of Covid-19 SARS-CoV-2: A Case Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      A novel coronavirus was identified in late 2019 in Wuhan, China On 11 February, The&#xD;
      International Committee on Taxonomy of Viruses (ICTV) announced that the official&#xD;
      classification of the new coronavirus (2019-nCoV) is called severe acute respiratory syndrome&#xD;
      coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) announced on the same day&#xD;
      that the official name of the disease caused by the virus is Corona Virus Disease-19&#xD;
      (COVID-19). WHO has declared the infection a Pandemic on March 11, 2020. Based on previous&#xD;
      studies on SARS in 2003 and SARS-MERS 2013 there was a genetic polymorphism associated with&#xD;
      the susceptibility and severity of the disease.&#xD;
&#xD;
      Interleukin-12 (IL-12) is a cytokine secreted by activated phagocytes and dendritic cells. It&#xD;
      plays a pivotal role in promoting Th1-type immune responses and cell-mediated immunity. IL-12&#xD;
      triggers many biological functions: it stimulates the proliferation of activated T- and&#xD;
      NK-cells, enhances T- and NK-cell-mediated cytolytic activity, and induces the production of&#xD;
      IFN-γ by both T-and NK-cells. The interferon-γ production induced by IL-12 forms a major link&#xD;
      between innate and adaptive immunity. A recent study revealed that interferon-mediated&#xD;
      immunopathological events are associated with atypical innate and adaptive immune responses&#xD;
      in SARS patients.&#xD;
&#xD;
      Also, TNF-α is a key mediator of the inflammatory response and is critical for host defense&#xD;
      against a wide variety of pathogenic microbes. However, the over-expression of this cytokine&#xD;
      may lead to badness in disease recovery. The dual role of TNF, acting as an agent of both&#xD;
      innate immunity and inflammatory pathology, poses a considerable challenge for gene&#xD;
      regulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 18, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure level of polymorphisms of interleukin (IL)-12 receptor B1 (IL-12RB1) and TNF- α alpha on COVID-19 related severe acute respiratory syndrome (SARS-CoV-2).</measure>
    <time_frame>day 1</time_frame>
    <description>genetic polymorphism</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Covid-19</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with confirmed COVID-19 PCR ( mild, moderate and severe cases) admitted to wards&#xD;
        or ICU Assiut University Hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with confirmed COVID-19 PCR ( mild, moderate and severe cases) admitted to&#xD;
             wards or ICU Assiut University Hospitals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected or non confirmed cases of COVID-19&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>AssiutU</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assiut University Hospitals</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Aliae AR Mohamed Hussein</investigator_full_name>
    <investigator_title>Professor of Pulmonology</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>corona virus disease</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>IL-12 RB gene polymorphism</keyword>
  <keyword>TNF gene polymorphism</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/NCT04462120
org study id: AssiutU15
nct id: NCT04462120
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A novel coronavirus was identified in late 2019 in Wuhan, China On 11 February, The
      International Committee on Taxonomy of Viruses (ICTV) announced that the official
      classification of the new coronavirus (2019-nCoV) is called severe acute respiratory syndrome
      coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) announced on the same day
      that the official name of the disease caused by the virus is Corona Virus Disease-19
      (COVID-19). WHO has declared the infection a Pandemic on March 11, 2020. Based on previous
      studies on SARS in 2003 and SARS-MERS 2013 there was a genetic polymorphism associated with
      the susceptibility and severity of the disease.

      Interleukin-12 (IL-12) is a cytokine secreted by activated phagocytes and dendritic cells. It
      plays a pivotal role in promoting Th1-type immune responses and cell-mediated immunity. IL-12
      triggers many biological functions: it stimulates the proliferation of activated T- and
      NK-cells, enhances T- and NK-cell-mediated cytolytic activity, and induces the production of
      IFN-γ by both T-and NK-cells. The interferon-γ production induced by IL-12 forms a major link
      between innate and adaptive immunity. A recent study revealed that interferon-mediated
      immunopathological events are associated with atypical innate and adaptive immune responses
      in SARS patients.

      Also, TNF-α is a key mediator of the inflammatory response and is critical for host defense
      against a wide variety of pathogenic microbes. However, the over-expression of this cytokine
      may lead to badness in disease recovery. The dual role of TNF, acting as an agent of both
      innate immunity and inflammatory pathology, poses a considerable challenge for gene
      regulation.
observational model: Cohort
time perspective: Prospective
measure: Measure level of polymorphisms of interleukin (IL)-12 receptor B1 (IL-12RB1) and TNF- α alpha on COVID-19 related severe acute respiratory syndrome (SARS-CoV-2).
time frame: day 1
description: genetic polymorphism
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
facility: 
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Aliae AR Mohamed Hussein
investigator title: Professor of Pulmonology
mesh term: COVID-19
sharing ipd: No