COVID-19, SARS-CoV 2 InfectionNCT04399733
EMPOWER - BAME vs COVID
An observational study of COVID-19, SARS-CoV 2 Infection and Health Disparities, run by Future Genetics Limited at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV 2 Infection, Health Disparities
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2021to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals who are registered as UK NHS patients
Who may be able to join
- 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
Who cannot join
- Patient is not registered with the NHS for care.
- Adults lacking capacity
- Children under the age of 6 years.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Future Genetics Limited
Birmingham, West Midlands, B15 2SQ
About this study
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
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.
Read the 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.
- 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
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 months
Secondary outcomes (1)
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Feb 2021 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Why it stopped: Vaccine rollouts in UK
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19, SARS-CoV 2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future Genetics Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Mohammed Kamran, Principal investigator, Future Genetics Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399733
- Sponsor's protocol ID
- EMPOWER-BAME vs COVID
- Status last verified
- Aug 2021
- First submitted
- 21 May 2020
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04399733
- Acronym / sponsor ID
- EMPOWER-BAME vs COVID
- 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
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Vaccine rollouts in UK
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Future Genetics LimitedUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 22 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ethnicity | – | –Patients will be segmented on a 1:1:1 ratio similar to the EMPOWER-1 study based on ethnicity (White, Black, South Asian). |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals who are registered as UK NHS patients
Key inclusion criteria (4 listed)
- All competent adult and children above the age of 5 years
- Subjects agree to:
Key exclusion criteria (3 listed)
- Patient is not registered with the NHS for care.
- Adults lacking capacity
- Children under the age of 6 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify COVID-19 specific host-defence ("protective") or predisposing ("susceptibility") genetic biomarkers
Time frame: 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.
1 secondary outcome
Epidemiological profiles of COVID-19 infections in different UK ethnic populations
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- FUTURE GENETICS websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Mohammed Kamran principal investigator
Future Genetics Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, SARS-CoV 2 Infection and Health Disparities, run by Future Genetics Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify COVID-19 specific host-defence ("protective") or predisposing ("susceptibility") genetic biomarkers (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.