EMPOWER - BAME vs COVID | NCT04399733

Studies
EMPOWER - BAME vs COVID

NCT04399733

Sponsor

Future Genetics Limited

Status

Withdrawn

Last Update Posted

Aug 26, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

COVID-19, SARS-CoV 2 Infection
Health Disparities

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Vaccine rollouts in UK

Expanded Access Info

Start Date

Feb 1, 2021Estimated

Primary Completion Date

Feb 1, 2023Estimated

Completion Date

Feb 1, 2024Estimated

First Submitted Date

May 21, 2020

First Submission Date that Met QC Criteria

May 21, 2020

First Posted Date

May 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2021

Last Update Posted Date

Aug 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Individuals who are registered as UK NHS patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr Mohammed Kamran	Future Genetics Limited	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Future Genetics Limited		Birmingham	West Midlands	B15 2SQ	United Kingdom

Label	URL
FUTURE GENETICS website	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

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Browse Branches

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