Clinical trial NCT04399733: EMPOWER - BAME vs COVID
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID-19, SARS-CoV 2 Infection
Health Disparities
Keywords: ethnic minority, health disparity, epidemiology, biomarker discovery, public health, BAME, morbidity, mortality, COVID-19, SARS-CoV-2
Lead sponsor: Future Genetics Limited
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are registered as UK NHS patients

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identify COVID-19 specific host-defence ("protective") or predisposing ("susceptibility") genetic biomarkers
timeFrame: 30 months
Secondary outcomes:
measure: Epidemiological profiles of COVID-19 infections in different UK ethnic populations
timeFrame: 24 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Future Genetics Limited
state: West Midlands
Study officials:
affiliation: Future Genetics Limited
name: Dr Mohammed Kamran
role: PRINCIPAL_INVESTIGATOR
References: