<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/NCT04462627</url>
  </required_header>
  <id_info>
    <org_study_id>CHUB-BDS-COVID19</org_study_id>
    <nct_id>NCT04462627</nct_id>
  </id_info>
  <brief_title>Reduction of COVID 19 Transmission to Health Care Professionals</brief_title>
  <official_title>Reduction of COVID 19 Transmission to Health Care Professionals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanane EL KENZ</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann University Hospital</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>
      When the COVID-19 virus infects a person, it enters the lung epithelial cells of its host and&#xD;
      uses its genetic material to replicate.&#xD;
&#xD;
      The pulmonary epithelial cells of a part of the population, known as &quot;secretors&quot;, are capable&#xD;
      of expressing the antigens of the &quot;ABO&quot; system on their surface. This secretory status can be&#xD;
      established by determining the antigens of the Lewis blood group system. When the virus&#xD;
      replicates in an &quot;secreting&quot; individual, the antigens of the &quot;ABO&quot; system of the infected&#xD;
      individual will be present on the surface of the viruses formed in his/her lungs.&#xD;
&#xD;
      It was shown in 2003 that the response of a given individual to the transmission of a virus&#xD;
      depends on his/her blood group and on the antigens of the &quot;ABO&quot; system carried by the virus.&#xD;
      A patient of group &quot;O&quot; would thus defend himself much better against a virus carrying&#xD;
      antigens of blood group &quot;A&quot;, the natural antibodies &quot;anti-A&quot; of the patient reducing the&#xD;
      ability of the virus to bind to its specific receptor on pulmonary epithelial cells, to&#xD;
      penetrate them to replicate itself. The first data collected in Wuhan (China) seems to&#xD;
      confirm this hypothesis. A COVID-19 virus transmission model can therefore be established on&#xD;
      the basis of blood groups.&#xD;
&#xD;
      In order to reduce the spread of the virus among nursing staff, it is possible to establish a&#xD;
      preferential algorithm for patient management based on the &quot;ABO&quot; and &quot;Lewis&quot; blood groups of&#xD;
      patients and &quot;ABO&quot; of nursing staff in health care units, if operational and human conditions&#xD;
      allow.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 14, 2020</start_date>
  <completion_date type="Actual">April 11, 2022</completion_date>
  <primary_completion_date type="Actual">April 11, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anti-A antibody concentration</measure>
    <time_frame>baseline</time_frame>
    <description>Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-A antibody concentration</measure>
    <time_frame>Day 4</time_frame>
    <description>Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-A antibody concentration</measure>
    <time_frame>Week 1</time_frame>
    <description>Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-A antibody concentration</measure>
    <time_frame>Week 2</time_frame>
    <description>Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-A antibody concentration</measure>
    <time_frame>Week 3</time_frame>
    <description>Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-B antibody concentration</measure>
    <time_frame>baseline</time_frame>
    <description>Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-B antibody concentration</measure>
    <time_frame>Day 4</time_frame>
    <description>Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-B antibody concentration</measure>
    <time_frame>Week 1</time_frame>
    <description>Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-B antibody concentration</measure>
    <time_frame>Week 2</time_frame>
    <description>Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-B antibody concentration</measure>
    <time_frame>Week 3</time_frame>
    <description>Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood group</measure>
    <time_frame>baseline</time_frame>
    <description>Blood group (ABO/LE)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">566</enrollment>
  <condition>COVID 19</condition>
  <arm_group>
    <arm_group_label>Covid 19 positive patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Covid 19 negative patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Untested healthy volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood group determination</intervention_name>
    <description>Determination of the blood group (ABO/LE)</description>
    <arm_group_label>Covid 19 negative patients</arm_group_label>
    <arm_group_label>Covid 19 positive patients</arm_group_label>
    <arm_group_label>Untested healthy volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Antibody titration</intervention_name>
    <description>Natural anti-A and anti-B antibody levels will be determined by a gel agglutination technique on the Biorad IH-500 automaton.</description>
    <arm_group_label>Covid 19 negative patients</arm_group_label>
    <arm_group_label>Covid 19 positive patients</arm_group_label>
    <arm_group_label>Untested healthy volunteers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic</intervention_name>
    <description>Administration of a probiotic to healthy volunteers to determine if it increases the level of circulating natural anti-A and anti-B antibodies (Probactiol Plus (Metagenics)).</description>
    <arm_group_label>Untested healthy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COVID19 positive patients admitted within the CHU Brugmann Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hanane El Kenz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Brugmann</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Brugmann</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 7, 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 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>Hanane EL KENZ</investigator_full_name>
    <investigator_title>Head Physician of the Blood Bank</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
  </intervention_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/NCT04462627
org study id: CHUB-BDS-COVID19
nct id: NCT04462627
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
When the COVID-19 virus infects a person, it enters the lung epithelial cells of its host and
      uses its genetic material to replicate.

      The pulmonary epithelial cells of a part of the population, known as "secretors", are capable
      of expressing the antigens of the "ABO" system on their surface. This secretory status can be
      established by determining the antigens of the Lewis blood group system. When the virus
      replicates in an "secreting" individual, the antigens of the "ABO" system of the infected
      individual will be present on the surface of the viruses formed in his/her lungs.

      It was shown in 2003 that the response of a given individual to the transmission of a virus
      depends on his/her blood group and on the antigens of the "ABO" system carried by the virus.
      A patient of group "O" would thus defend himself much better against a virus carrying
      antigens of blood group "A", the natural antibodies "anti-A" of the patient reducing the
      ability of the virus to bind to its specific receptor on pulmonary epithelial cells, to
      penetrate them to replicate itself. The first data collected in Wuhan (China) seems to
      confirm this hypothesis. A COVID-19 virus transmission model can therefore be established on
      the basis of blood groups.

      In order to reduce the spread of the virus among nursing staff, it is possible to establish a
      preferential algorithm for patient management based on the "ABO" and "Lewis" blood groups of
      patients and "ABO" of nursing staff in health care units, if operational and human conditions
      allow.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Anti-A antibody concentration
time frame: baseline
description: Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
measure: Anti-A antibody concentration
time frame: Day 4
description: Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
measure: Anti-A antibody concentration
time frame: Week 1
description: Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
measure: Anti-A antibody concentration
time frame: Week 2
description: Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
measure: Anti-A antibody concentration
time frame: Week 3
description: Anti-A antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
measure: Anti-B antibody concentration
time frame: baseline
description: Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
measure: Anti-B antibody concentration
time frame: Day 4
description: Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
measure: Anti-B antibody concentration
time frame: Week 1
description: Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
measure: Anti-B antibody concentration
time frame: Week 2
description: Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
measure: Anti-B antibody concentration
time frame: Week 3
description: Anti-B antibody titration, as determined by gel agglutination on the Biorad IH-500 automated system.
measure: Blood group
time frame: baseline
description: Blood group (ABO/LE)
arm group label: Covid 19 positive patients
arm group type: Experimental
arm group label: Covid 19 negative patients
arm group type: Experimental
arm group label: Untested healthy volunteers
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: Blood group determination
description: Determination of the blood group (ABO/LE)
arm group label: Covid 19 negative patients
arm group label: Covid 19 positive patients
arm group label: Untested healthy volunteers
intervention type: Diagnostic Test
intervention name: Antibody titration
description: Natural anti-A and anti-B antibody levels will be determined by a gel agglutination technique on the Biorad IH-500 automaton.
arm group label: Covid 19 negative patients
arm group label: Covid 19 positive patients
arm group label: Untested healthy volunteers
intervention type: Dietary Supplement
intervention name: Probiotic
description: Administration of a probiotic to healthy volunteers to determine if it increases the level of circulating natural anti-A and anti-B antibodies (Probactiol Plus (Metagenics)).
arm group label: Untested healthy volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hanane El Kenz, MD
role: Principal Investigator
affiliation: CHU Brugmann
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: Hanane EL KENZ
investigator title: Head Physician of the Blood Bank
mesh term: COVID-19
mesh term: Antibodies
sharing ipd: No