<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/NCT04399733</url>
  </required_header>
  <id_info>
    <org_study_id>EMPOWER-BAME vs COVID</org_study_id>
    <nct_id>NCT04399733</nct_id>
  </id_info>
  <brief_title>EMPOWER - BAME vs COVID</brief_title>
  <official_title>EMPOWER - BAME vs COVID: A Multi-site Clinical Cohort Research Study to Identify Genetic Associations and Candidate Therapeutic Targets to Reduce COVID-19 Morbidity &amp; Mortality Rates in BAME Populations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Future Genetics Limited</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Future Genetics Limited</source>
  <oversight_info>
    <has_dmc>Yes</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 COVID-19 virus pandemic has massively affected us all. Moreover, there is a&#xD;
      disproportionately high number of COVID-19 severe infections and deaths in British Black,&#xD;
      Asian and minority ethnic (BAME) patients. This clinical study plans to discover new ways of&#xD;
      protecting people from this virus by looking at our DNA and biology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The COVID-19 virus pandemic has massively affected us all. We now know there is a much larger&#xD;
      proportion of British Black, Asian and minority ethnic (BAME) patients suffering from&#xD;
      COVID-19 infections. This disproportionate level of infection and severity of disease has&#xD;
      raised concerns and worries. Other research from April 2020 showed that 71% of the nurses and&#xD;
      midwives and 94% of the doctors and dentists that died of COVID-19 infections were from a&#xD;
      BAME background despite this group representing 20% and 44% of the workforce respectively.&#xD;
      The survival picture is also grim for Black and Asian members of the public where we see&#xD;
      disproportionately high rates of deaths. Research estimates that our DNA and the environment&#xD;
      equally influence the risk for infection. This clinical study plans to better understand our&#xD;
      DNA. Some of the things we will be looking at is age, sex, ethnicity and any illnesses such&#xD;
      as diabetes or blood pressure. We will ask people for some spit and look at their medical&#xD;
      records. This may help us find some of the reasons why this virus has different effects on&#xD;
      people and how we might protect people from COVID-19.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Vaccine rollouts in UK&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 1, 2021</start_date>
  <completion_date type="Anticipated">February 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2023</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>Identify COVID-19 specific host-defence (&quot;protective&quot;) or predisposing (&quot;susceptibility&quot;) genetic biomarkers</measure>
    <time_frame>30 months</time_frame>
    <description>Discovery of genetic associations with COVID-19 infections that may form the basis of prevention, treatment or management of at-risk BAME groups and the wider population.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Epidemiological profiles of COVID-19 infections in different UK ethnic populations</measure>
    <time_frame>24 months</time_frame>
    <description>Measure the variation and extent of the different types of COVID-19 infection in different populations</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID-19, SARS-CoV 2 Infection</condition>
  <condition>Health Disparities</condition>
  <arm_group>
    <arm_group_label>Ethnicity</arm_group_label>
    <description>Patients will be segmented on a 1:1:1 ratio similar to the EMPOWER-1 study based on ethnicity (White, Black, South Asian).</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals who are registered as UK NHS patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All competent adult and children above the age of 5 years&#xD;
&#xD;
          2. Subjects agree to:&#xD;
&#xD;
               1. Gift saliva (spit) samples&#xD;
&#xD;
               2. Provide Consent for access to medical and health records&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is not registered with the NHS for care.&#xD;
&#xD;
          2. Adults lacking capacity&#xD;
&#xD;
          3. Children under the age of 6 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Mohammed Kamran</last_name>
    <role>Principal Investigator</role>
    <affiliation>Future Genetics Limited</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Future Genetics Limited</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B15 2SQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://futuregenetics.co.uk/</url>
    <description>FUTURE GENETICS website</description>
  </link>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>August 21, 2021</last_update_submitted>
  <last_update_submitted_qc>August 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ethnic minority, health disparity, epidemiology, biomarker discovery, public health, BAME, morbidity, mortality, COVID-19, SARS-CoV-2</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/NCT04399733
org study id: EMPOWER-BAME vs COVID
nct id: NCT04399733
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The COVID-19 virus pandemic has massively affected us all. Moreover, there is a
      disproportionately high number of COVID-19 severe infections and deaths in British Black,
      Asian and minority ethnic (BAME) patients. This clinical study plans to discover new ways of
      protecting people from this virus by looking at our DNA and biology.
The COVID-19 virus pandemic has massively affected us all. We now know there is a much larger
      proportion of British Black, Asian and minority ethnic (BAME) patients suffering from
      COVID-19 infections. This disproportionate level of infection and severity of disease has
      raised concerns and worries. Other research from April 2020 showed that 71% of the nurses and
      midwives and 94% of the doctors and dentists that died of COVID-19 infections were from a
      BAME background despite this group representing 20% and 44% of the workforce respectively.
      The survival picture is also grim for Black and Asian members of the public where we see
      disproportionately high rates of deaths. Research estimates that our DNA and the environment
      equally influence the risk for infection. This clinical study plans to better understand our
      DNA. Some of the things we will be looking at is age, sex, ethnicity and any illnesses such
      as diabetes or blood pressure. We will ask people for some spit and look at their medical
      records. This may help us find some of the reasons why this virus has different effects on
      people and how we might protect people from COVID-19.
observational model: Cohort
time perspective: Prospective
measure: Identify COVID-19 specific host-defence ("protective") or predisposing ("susceptibility") genetic biomarkers
time frame: 30 months
description: Discovery of genetic associations with COVID-19 infections that may form the basis of prevention, treatment or management of at-risk BAME groups and the wider population.
measure: Epidemiological profiles of COVID-19 infections in different UK ethnic populations
time frame: 24 months
description: Measure the variation and extent of the different types of COVID-19 infection in different populations
arm group label: Ethnicity
description: Patients will be segmented on a 1:1:1 ratio similar to the EMPOWER-1 study based on ethnicity (White, Black, South Asian).
Saliva
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dr Mohammed Kamran
role: Principal Investigator
affiliation: Future Genetics Limited
facility: 
country: United Kingdom
url: https://futuregenetics.co.uk/
description: FUTURE GENETICS website
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No