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EMPOWER - BAME vs COVID

Sponsor
Future Genetics Limited (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04399733
Collaborator
(none)
0
Enrollment
1
Location
36
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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 & Mortality Rates in BAME Populations
    Anticipated Study Start Date :
    Feb 1, 2021
    Anticipated Primary Completion Date :
    Feb 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Ethnicity

    Patients will be segmented on a 1:1:1 ratio similar to the EMPOWER-1 study based on ethnicity (White, Black, South Asian).

    Outcome Measures

    Primary Outcome Measures

    1. Identify COVID-19 specific host-defence ("protective") or predisposing ("susceptibility") genetic biomarkers [30 months]

      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.

    Secondary Outcome Measures

    1. Epidemiological profiles of COVID-19 infections in different UK ethnic populations [24 months]

      Measure the variation and extent of the different types of COVID-19 infection in different populations

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. All competent adult and children above the age of 5 years

    2. Subjects agree to:

    3. Gift saliva (spit) samples

    4. Provide Consent for access to medical and health records

    Exclusion Criteria:

    1. Patient is not registered with the NHS for care.

    2. Adults lacking capacity

    3. Children under the age of 6 years.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Future Genetics Limited Birmingham West Midlands United Kingdom B15 2SQ

    Sponsors and Collaborators

    • Future Genetics Limited

    Investigators

    • Principal Investigator: Dr Mohammed Kamran, Future Genetics Limited

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Future Genetics Limited
    ClinicalTrials.gov Identifier:
    NCT04399733
    Other Study ID Numbers:
    • EMPOWER-BAME vs COVID
    First Posted:
    May 22, 2020
    Last Update Posted:
    Aug 26, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Future Genetics Limited
    ethnic minority, health disparity, epidemiology, biomarker discovery, public health, BAME, morbidity, mortality, COVID-19, SARS-CoV-2
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Aug 26, 2021