NCT04399733

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

May 21, 2020

Last Update Submit

August 21, 2021

Conditions

COVID-19, SARS-CoV 2 InfectionHealth Disparities

Keywords

ethnic minority, health disparity, epidemiology, biomarker discovery, public health, BAME, morbidity, mortality, COVID-19, SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Epidemiological profiles of COVID-19 infections in different UK ethnic populations

    24 months

Study Arms (1)

Ethnicity

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

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who are registered as UK NHS patients

You may qualify if:

  • All competent adult and children above the age of 5 years
  • Subjects agree to:
  • Gift saliva (spit) samples
  • Provide Consent for access to medical and health records

You may not qualify if:

  • Patient is not registered with the NHS for care.
  • Adults lacking capacity
  • Children under the age of 6 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Future Genetics Limited

Birmingham, West Midlands, B15 2SQ, United Kingdom

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Dr Mohammed Kamran

    Future Genetics Limited

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2020

First Posted

May 22, 2020

Study Start

February 1, 2021

Primary Completion

February 1, 2023

Study Completion

February 1, 2024

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)