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.
