EMPOWER - BAME vs COVID

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Health Disparities; COVID-19, SARS-CoV 2 Infection

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 Type: Observational

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2SQ
      • Future Genetics Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals who are registered as UK NHS patients

Description

Inclusion Criteria:

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

2. Subjects agree to:

   1. Gift saliva (spit) samples
   2. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify COVID-19 specific host-defence ("protective") or predisposing ("susceptibility") genetic biomarkers	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.	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epidemiological profiles of COVID-19 infections in different UK ethnic populations	Measure the variation and extent of the different types of COVID-19 infection in different populations	24 months

Collaborators and Investigators

• Sponsor: Future Genetics Limited
• Investigators: Principal Investigator: Dr Mohammed Kamran, Future Genetics Limited

Publications and helpful links

Helpful Links

• FUTURE GENETICS website

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 21, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 21, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: ethnic minority, health disparity, epidemiology, biomarker discovery, public health, BAME, morbidity, mortality, COVID-19, SARS-CoV-2
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: EMPOWER-BAME vs COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No