COVID-19 research

Valneva VAL2001-201 - Phase 1 COVID-19 Vaccine Trial

Recruitment is now open to a phase 1, first in man COVID-19 vaccine trial being sponsored and funded by Valneva. Screening for the first 15 'sentinel' participants, who will all be recruited in Bristol and vaccinated at UHBW, began on 16th December. Further recruitment and screening will take place in January, and volunteers who are aged 18-55, live in the central Bristol area and are in good health could be eligible to participate.

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

ENSEMBLE 2 - Janssen COVID-19 vaccine trial

Recruitment is now open to the COVID-19 vaccine trial (ENSEMBLE 2) being sponsored and funded by Janssen. Volunteers are sought from across the West of England region to take part and we're looking to recruit and vaccinate at least 333 people across the region. Screening and vaccination visits will take place at UHBW or NBT. People from the West of England who are interested in taking part in the Janssen ENSEMBLE 2 vaccine study can register their interest by completing the pre-screening questionnaire on the ENSEMBLE website.

More details can be found here: https://www.uhbw.nhs.uk/p/latest-news/urgent-call-for-volunteers-across-the-west-of-england-to-take-part-in-a-new-cov.

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

RECOVERY

The RECOVERY COVID-19 randomised controlled trial (RCT) and 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.

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.

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.

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.

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, or by contacting the Bristol team on 0117 342 5756 or by emailing Research@uhbw.nhs.uk

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.

AERATOR study

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.