EMPOWER - BAME vs COVID

Withdrawn

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

• Registration Number: NCT04399733
• Lead Sponsor: Future Genetics Limited

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.

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-22
• Study Start: 2021-02-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-21
• Last Update Posted: 2021-08-26
• Primary Completion: 2023-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Future Genetics Limited; 🇬🇧 Birmingham, West Midlands, United Kingdom