COVID-19 research
During the COVID-19 pandemic UHBW research teams have delivered
an array of clinical trials and research studies to help to develop
vaccines and treatments for COVID-19, as well as to learn more
about the disease. Some of the research we have been involved in is
outlined below.
Vaccine trials
Moderna Omicron booster vaccine trial
The mRNA-1273-P305 trial is evaluating the safety and immune
response of investigational Omicron variant vaccines compared to a
booster dose of Moderna's COVID-19 vaccine, SPIKEVAX.
This trial enrolled volunteers 16 years of age or older who are
in good or stable health and have received two or three doses of
the COVID-19 vaccine at least 90 days ago. 79 participants were
recruited at UHBW.
Participation in this trial lasts up to 13 months and includes
phone calls and approximately 5-7 scheduled visits to the trial
site. Participants will receive a single dose of either one of the
investigational Omicron variant vaccines: mRNA-1273.529,
mRNA-1273.214, or the already authorized vaccine, SPIKEVAX.
To learn more visit the website
https://connect.trialscope.com/studies/0a9015ce-4de7-49a8-8683-a2f5fe6fa455/
or contact vaccinetestingresearch@uhbw.nhs.uk
Preg-COV - A Phase II, randomised, single-blind, platform trial
to assess safety, reactogenicity and immunogenicity of COVID-19
vaccines in pregnant women in the United Kingdom
St Michael's Hospital are a site for this study which will
provide vital information about which COVID-19 vaccine schedule
works best in pregnancy. The study will look at which interval
between doses best protects women and their babies. Participation
involves visits throughout pregnancy and up to one year after
delivery.
To find out more, please visit vaccine.ac.uk, call 0117 342 5756 or email research_st.michaels@uhbw.nhs.uk.
Valneva VAL2001-301 - COV-COMPARE - Immunogenicity of vaccine
VLA2001 compared to AZD1222
Valneva has now added an adolescent arm (12 - 17 years old) to
the Phase 3 clinical trial to test a new candidate vaccine against
COVID-19. Participation involves 3 dosing appointments and 4
follow-up appointments over the course of 12 months.
163 adult participants and 20 adolescents were enrolled at
UHBW.
The National Institute for Health Research (NIHR)-supported
Valneva Phase 2/3 study, is being run across sites in the UK
including UHBW and North Bristol NHS Trust.
4,000 participants have been recruited across the UK, and
everyone involved in the study will receive two active vaccine
doses, administered in a four week interval. Those enrolled in the
study over the age of 30 have been randomised to receive two doses
of either the Valneva vaccine, or the approved Oxford/AstraZeneca
vaccine. Participants aged 18 - 29 enrolled into the study will
receive the Valneva vaccine and will not be offered the approved
Oxford/AstraZeneca vaccine.
To find out more information please visit https://www.ukcovid19study.com/
Oxford/AstraZeneca COV009 trial - Safety & immunogenicity
extension study for ChAdOx1 nCoV-19
UHBW have recruited 301 participants who took part in the COV001
and COV002 trials of the now licenced Oxford/AstraZeneca ChAdOx1
nCoV-19, to join the COV009 trial. The trial aims to determine the
long-term safety and character of immunological responses to the
ChAdOx1 nCoV-19 coronavirus vaccine.
AZ BOOST - Phase II/III Study of AZD2816 for the Prevention of
COVID-19 in Adults
UHBW recruited 57 participants to this phase II/III trial,
sponsored and led by AstraZeneca which will is running across the
UK, South Africa, Brazil and Poland.
AZD2816 will be administered to individuals who have previously
been fully vaccinated with two doses of the original
Oxford-AstraZeneca vaccine or an mRNA vaccine, at least three
months after their last injection. In non-vaccinated individuals,
AZD2816 will be given as two doses, four or twelve weeks apart, or
given as a second dose following a first dose of original
Oxford-AstraZeneca vaccine four weeks apart.
For the UK booster study launch participants must have received
two doses of an approved COVID-19 vaccine three to 12 weeks apart
more than three months prior to the study.
The new vaccine, known as AZD2816 has been designed using the
same adenoviral vector platform developed by researchers at the
University of Oxford using the ChAdOx platform technology, with
minor genetic alterations to the spike protein based on the Beta
(B.1.351, South African) variant.
ComFluCov
The ComFluCOV vaccine study is a collaboration between the
University of Bristol, University Hospitals Bristol and Weston NHS
Foundation Trust and the University of Oxford, and run by the
Bristol Trials Centre. The study is looking at the safety, as well
as the immune responses, when giving currently approved COVID-19
vaccines at the same time as the recommended influenza (flu)
vaccines from the 2020/21 flu season programme.
This study is Sponsored by University Hospitals Bristol and
Weston NHS Foundation Trust (Chief Investigator Dr Rajeka
Lazarus).
Recruitment is now closed to the ComFluCov trial and
participants have now completed the trial. 111 participants were
enrolled at UHBW, and 679 participants were enrolled at randomised
across all sites.
The initial study results were published in The Lancet in
November 2021, and will be used to inform UK immunisation
policy:
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02329-1/fulltext
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 aimed to recruit 756 participants people aged 18 years
old or over who had received their first COVID-19 vaccination and
were awaiting their second dose across a network of NHS sites in
England and Wales including 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 received 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, visit the vaccine trial
website: https://comflucov.blogs.bristol.ac.uk/
Oxford/AstraZeneca COV006 - COVID-19 vaccine in children
We have now completed recruitment to this trial. 72 children and
young adults were successfully recruited and remain in follow
up.
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 the 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
This COVID-19 vaccine trial (ENSEMBLE 2) is 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 received 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 here: https://gb.ensemblestudy.com/
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 (https://www.uhbw.nhs.uk/p/latest-news/researchers-to-begin-new-phase-of-covid-19-vaccine-trials)
and on the trial's website (https://covid19vaccinetrial.co.uk/participate-bristol).
Treatment trials and other COVID-19 studies
RECOVERY
The international RECOVERY COVID-19 randomised controlled trial
(RCT) aims to identify treatments that may be beneficial for people
hospitalised with suspected or confirmed COVID-19 and is open in
the BRI, BHOC, Weston and the children's hospital at UHBW. RECOVERY
has now recruited over 10,000 patients nationally, a remarkable
achievement. Please contact Research@uhbw.nhs.uk for
more information or visit The RECOVERY Trial website (https://www.recoverytrial.net/?223e66da-225c-11ed-8e27-0a442fc5b724).
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. For more information please
contact Research@uhbw.nhs.uk, or
visit the trial website (http://www.remapcap.org/).
TACTIC-R
TACTIC-R is a phase II platform randomised clinical trial
targeted at high risk pre-ICU confirmed/suspect Covid patients.
Patients were randomised to receive standard care or one of two
existing drugs, Baricitinib or Ravulizumab. The study aimed to
prevent patients from being admitted to ICU.
The TACTIC-R study is now closed to recruitment. 6 participants
were recruited to the study at UHBW.
Heal COVID
HEAL-COVID is a clinical trial to compare different treatments
that could prevent or reduce long term symptoms in COVID-19
patients. The main objective of HEAL-COVID is to determine whether
the treatments used improve longer-term outcomes for COVID-19
patients. Patients who are admitted to UHBW with COVID-19 will be
invited to take part shortly before they are discharged home and
will be randomly allocated to receive one of three treatments. The
trial sponsor is Cambridge University Hospitals NHS Foundation
Trust. For more information, please contact Research@uhbw.nhs.uk
Assessment of chemoreflex control of respiratory and
cardiovascular systems in Post-COVID-19 syndrome
This study sponsored by the University of Bristol opened to
recruitment in the Bristol Heart Institute and will be run by the
Cardionomics group with Dr Angus Nightingale as the Chief
Investigator. The study will be looking to recruit 54 people to 2
groups: firstly, a group with Post-COVID-19 Syndrome and secondly a
matched control group with COVID-19 symptoms lasting no longer than
4 weeks as per NICE guidelines. The study will assess chemoreflex
control of respiratory and cardiovascular systems in Post-COVID-19
syndrome.
SINEPOST study - SARS-CoV-2 Infection in NEonates or in
Pregnancy: Outcomes at EighTeen months
The SINEPOST study opened to recruitment at St Michael's
hospital. The study will check the development of babies exposed to
Coronavirus infection and compare it with the development of babies
who did not have Coronavirus infection to find out if there are any
lasting effects.
NHS Blood and Transplant (NHSBT) COVID-19 convalescent plasma
programme
NHSBT invited NHS colleagues who had recovered from COVID-19 to
donate plasma to support research into the treatment of COVID-19.
The Department of Health and Social Care has now asked NHS Blood
and Transplant to stop collecting convalescent plasma
donations.
This follows the completed analysis of trial results for REMAP
CAP and RECOVERY which showed no overall benefit for people in
hospital with coronavirus and a decision not to proceed with a
third trial into plasma use early in the disease.
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. The study is now
closed to recruit, with 498 members of staff having been recruited
at UHBW. More information can be found on the study website here:
https://snapsurvey.phe.org.uk/siren/
WHAT'S THE STORY
This study is being run at Bristol Royal Hospital for Children
and is collecting blood samples to look at antibody levels against
certain infectious diseases (including COVID). Recruitment is now
closed, with 425 recruits from UHBW. 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 (http://www.bristol.ac.uk/news/2020/may/logic-study.html).
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 is funded by The Grand Appeal,. 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 recruited adults over 18 years, diagnosed with
SARS-CoV-2 infection (COVID-19) with indication of heart damage
(raised cardiac biomarker [Troponin]). Patients were 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 was also 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 now closed in Bristol. More info on the study
website (https://pan-covid.org/), or 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.
