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COVID-19 research

Vaccine trials

New Trial Open

Moderna Omicron booster vaccine trial

We are looking for volunteers to take part in a study evaluating investigational booster vaccines that may protect against the COVID-19 Omicron variant and other variants and you may be eligible to take part.

The mRNA-1273-P305 clinical trial is being run by Moderna, and we are looking to enrol volunteers at UHBW. The 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 is enrolling 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.

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


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.

Combining Influenza and COVID-19 (ComFluCov) study - UPDATE

Researchers from the ComFluCOV study have found that it is safe for people to receive a flu vaccine at the same time as a COVID-19 vaccine. Reported side effects were mainly mild to moderate, and there were no negative impacts on the immune response produced by either vaccine when both were given on the same day, in opposite arms.

You can read more about these results in the news story on our website:  https://www.uhbw.nhs.uk/p/latest-news/it-is-safe-for-people-to-be-vaccinated-against-covid-19-and-influenza-at-the-sa

ENSEMBLE 2 - Janssen COVID-19 vaccine trial

Recruitment is now closed to the 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 received two doses of the active vaccine or placebo, and will now be followed up for two years. More information about the trial can be found on the ENSEMBLE website.

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

Oxford/AstraZeneca COV009 trial -Safety & immunogenicity extension study for ChAdOx1 nCoV-19

UHBW are now actively recruitingparticipants who took part in the COV001 and COV002 trialsof the now licenced Oxford/AstraZeneca ChAdOx1 nCoV-19, to join the COV009 trial.The trial aims todetermine the long-term safety and character of immunological responses to the ChAdOx1 nCoV-19 coronavirus vaccine. 

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

Preg-COV Trial Now Open

Preg-COV trial now open - UHBW is looking for pregnant volunteers to participate in a COVID-19 vaccine trial

St. Michael's Hospital in Bristol is inviting pregnant women to participate in a study evaluating COVID-19 vaccines in pregnancy.

This study 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. Participants will be reimbursed for travel expenses.

To find out more, please visit vaccine.ac.uk, call 0117 342 5756 or email research_st.michaels@uhbw.nhs.uk

Taking part in research Vaccine passport / Certification and Travel

The NIHR has produced some information about Vaccine passports for people on trials.  Please visit:  https://bepartofresearch.nihr.ac.uk/Vaccine-studies/Latest-vaccine-news 

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 

Valneva VAL2001-301 - COV-COMPARE - Immunogenicity of vaccine VLA2001 compared to AZD1222- now includes adolescents - UPDATE

Valnevahas now added an adolescent arm(12 - 17 years old) tothePhase 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. 

To sign up and find out more information please visit https://www.ukcovid19study.com/

Treatment trials and other COVID-19 studies

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

Assessment of Chemoreflex Control of Respiratory and Cardiovascular Systems in Post-COVID-19 Syndrome

This study sponsored by the University of Bristol has recently 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. 

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

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 visit genomicc.org.

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 and local PI is Emma Stratton. For more information, please contact Research@uhbw.nhs.uk

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.

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

Last year 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.

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

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.

SINEPOST study - SARS-CoV-2 Infection in NEonates or in Pregnancy: Outcomes at EighTeen months

The SINEPOST study has recently opened to recruitmentat St Michaels 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.

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/

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. 

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.

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)