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COVID-19 research

Vaccine trials

ComFluCov

Researchers at the Bristol Trials Centre (CTEU) at the University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) are leading a new study which could set the foundations for how booster COVID-19 vaccinations are delivered in the future. The study, supported by the National Institute for Health Research (NIHR), will determine whether booster COVID-19 vaccines should be given at the same time as flu vaccines.

The study will look at the side effects and immune response given when people receive their COVID-19 booster and flu vaccine at the same appointment.

The study is open to recruitment and is looking for people aged 18 years old or over who have received their first COVID-19 vaccination and are awaiting their second dose. It will look to recruit 504 participants across six NHS sites: Gloucestershire Hospitals NHS Foundation Trust, Great Western Hospitals NHS Foundation Trust, North Bristol NHS Trust, Royal Cornwall Hospitals NHS Trust, Royal United Hospitals Bath NHS Foundation Trust and UHBW.

Each participant will receive the second dose of the same COVID-19 vaccine they originally received, either the Pfizer/BioNTech COVID-19 vaccine or the Oxford/AstraZeneca COVID-19 vaccine.

For more information about the study and how to sign up, visit the vaccine trial website: https://comflucov.blogs.bristol.ac.uk/

Oxford/AstraZeneca COV006 - COVID-19 vaccine in children

Children and young adults are being invited to take part in the first study to assess the safety and immune response to the COVID-19 vaccine, which will be running at UHBW, beginning the week commencing 22nd February 2021.

More information about the trial can be found here: https://www.nihr.ac.uk/news/first-childrens-covid-19-vaccine-trial-open/26870

Valneva VAL2001-201 - Phase 1 COVID-19 vaccine trial

We have now completed recruitment to this phase 1, first in man COVID-19 vaccine trial being sponsored and funded by Valneva. 56 volunteers were successfully recruited to the trial at UHBW and remain on trial.

More details can be found here: https://www.nihr.ac.uk/news/fifth-covid-19-vaccine-to-be-tested-at-four-uk-sites/26413

ENSEMBLE 2 - Janssen COVID-19 vaccine trial

Recruitment is now closed to this COVID-19 vaccine trial (ENSEMBLE 2) being sponsored and funded by Janssen. Screening and vaccination visits took place at UHBW or NBT, and 333 volunteers from across the West of England region were successfully recruited. Participants will receive two doses of the active vaccine or placebo, and will then be followed up for two years. More information about the trial can be found on the ENSEMBLE website.

Oxford vaccine trials (COV001 and COV002)

We have completed recruitment for both the Phase I/II and Phase II/III Oxford vaccine trials. UHBW have recruited over 600 participants across the two trials, and both are in follow up until Autumn 2021.  Find out more in our news story on our  public website and on the trial's website.

Treatment  trials

RECOVERY

The RECOVERY COVID-19 randomised controlled trial (RCT) is open in the BRI, BHOC, Weston and the children's hospital. RECOVERY has now recruited over 10,000 patients nationally, a remarkable achievement. Please contact Research@uhbw.nhs.uk for more information.

REMAP-CAP

REMAP-CAP is a global RCT that is recruiting patients in ICU, and uses an innovative design that allows evaluation of multiple interventions; antivirals, steroids, immunomodulation, plasma and now a newly added anticoagulation arm. We have recruited five patients here at UHBW and the global recruitment is 439. For more information please contact Research@uhbw.nhs.uk, or visit the trial website.

TACTIC-R

TACTIC-R is a phase II platform randomised clinical trial targeted at high risk pre-ICU confirmed/suspect Covid patients. Patients will be randomised to receive standard care or one of two existing drugs, Baricitinib or Ravulizumab. The study is aiming to prevent patients from admission to ICU. The platform design also means that new, more effective treatments can be added and less effective treatments can be removed. The trial sponsor is University Hospitals Cambridge and local PI is Charlotte Bradbury. For more information, please contact Research@uhbw.nhs.uk.

NHS Blood and Transplant (NHSBT) COVID-19 convalescent plasma programme

NHSBT urgently needs plasma donated by NHS colleagues who have recovered from COVID-19 to support research into the treatment of COVID-19. If you have had a positive test for COVID-19, or have had symptoms of COVID-19, please visit the NHSBT website to find out how you can donate at a local centre in Bristol or Gloucester. Patients in the REMAP CAP trial will be receiving treatment with convalescent plasma and patients in the RECOVERY trial will also be receiving it when donations allow.

SIREN study

The purpose of the SIREN study is to understand whether prior infection with SARS-CoV2 (the virus that causes COVID-19) protects against future infection with the same virus.

WHAT'S THE STORY

This study is open in the Bristol Royal Hospital for Children and is collecting blood samples to look at antibody levels against certain infectious diseases (including COVID). Further information can be found on the trial's website (https://trials.ovg.ox.ac.uk/trials/what-is-story)

LOGIC study

Frontline staff from the paediatric emergency department at Bristol Royal Hospital for Children are taking part in the LOGIC study.

Over a three month period, researchers are tracking the symptoms of 125 staff members, including the presence of the virus in saliva, throat and nose swabs and the development of immunity (including antibodies) in their blood.

The study, which is funded by The Grand Appeal, is still recruiting staff from the paediatric ED. For more information, please contact Research@uhbw.nhs.uk.

GenOMICC

All critically ill patients with COVID-19 are eligible for GenOMICC. This study aims to identify genes that cause increased susceptibility to becoming seriously ill with COVID-19 and then beneficial treatments. For more information, please contact Research@uhbw.nhs.uk or visit genomicc.org.

COVID HEART study

Multi-centre observational cohort study working to describe the prevalence and extent of heart muscle injury in patients with COVID-19 and determinants (blood biomarkers, severity of acute infection, genetics, and comorbidities) of adverse clinical outcome in this population.

This study is recruiting adults over 18 years, diagnosed with SARS-CoV-2 infection (COVID-19) with indication of heart damage (raised cardiac biomarker [Troponin]). Patients will be required to have a cardiac MRI, an electrocardiogram (ECG) and to complete a 6 minute walk test and questionnaire at baseline and 6 months later. An optional blood test will also be taken for genetic and immunological testing.
For more information, please contact Research@uhbw.nhs.uk

PANCOVID study

St Michael's Hospital is one of a number of sites in the UK and internationally that is taking part in the PANCOVID study. The main study team is based at Imperial College London. The study is looking for pregnant women that have had coronavirus symptoms during their pregnancy, to find out more about the effect of COVID-19 on early pregnancy, the growth of babies, early birth and possible infection of babies.

Recruitment is ongoing in Bristol. More info on the study website, by contacting the Bristol team on 0117 342 5756 or by emailing Research@uhbw.nhs.uk

AERATOR study 

The AERosolisation And Transmission Of SARS-CoV-2 in Healthcare Settings (AERATOR) study, an Urgent Public Health study led by North Bristol NHS Trust (NBT) together with the University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust (UHBW), aims to rapidly study the amount and type of aerosol generated when medical procedures are performed, and how infectious this aerosol is. The study will be carried out at participating sites using specialist equipment in operating theatres and wards to measure real-life aerosol generation in five clinical settings: dental, orthopaedic, respiratory, critical care and ophthalmology. By using specialist equipment, only available at the University of Bristol, the research team will also investigate how long coronavirus survives while airborne and how environmental conditions impact on the infectivity of the virus. For more information, please contact Research@uhbw.nhs.uk

The UNITE database - a united team effort

The UNITE database is open. UNITE provides a single point of data capture for six COVID-19 observational studies. Previously six separate research teams were entering (the same) data into six separate databases. Now we have a team entering the data in one database (UNITE) and pathology and Medway data are automatically uploaded to save time.

The data for each study are automatically extracted and sent to the individual databases. We hope this will save time, improve efficiency and ultimately provide good quality data to better understand COVID-19. UNITE has been built by Mark Lyttle, paediatric emergency department consultant, Mai Baquedano, senior research associate, and Cat Hyams, respiratory medicine specialist registrar, with the support of IM&T, business intelligence and information governance. If you have any questions or would like to help with data submission please email Research@uhbw.nhs.uk.

These trials are supported by clinicians and research nurses from across the Trust in a collaboration to generate evidence for the best treatments and interventions for COVID-19. If you would like to know more or get involved, please contact Research@uhbw.nhs.uk.