Update on COVID-19 research in Suffolk - 21/01/2021 COVID-19 Research results
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Update on COVID-19 research in Suffolk – 21/01/2021 COVID-19 Research results: SIREN study - the first report from this vital study to monitor post-COVID-infection immunity highlights that past COVID-19 infection provides some immunity for at least 5 months, but people may still carry and transmit the virus. Between June and November, researchers detected 44 potential reinfections out of 6,614 participants (healthcare workers across 102 NHS Trusts) who had tested positive for antibodies. This represents an 83% rate of protection from reinfection. PHE cautions that although those with antibodies have some protection from becoming ill with COVID-19 themselves, early evidence from the next stage of the study suggests that some of these individuals carry high levels of virus and could continue to transmit the virus to others. Read the press release from PHE here. Results from the REMAP-CAP clinical trial show the drugs tocilizumab and sarilumab reduced the risk of death by 24% for clinically ill patients and time spent in intensive care by up to 10 days. Updated guidance has been issued by the government and the NHS to trusts across the UK, encouraging them to use tocilizumab in treatment of COVID-19 patients who are admitted to intensive care units. Read the press release from the DHSC here. Key Updates - ongoing and new studies: PRINCIPLE One of the key priority Urgent Public Health studies to test different medications to see whether this reduces the need for hospitalisation or will speed up recovery in older patients. The Azithromycin and Doxycycline arms of the study are now discontinued. Standard care and treatment with the inhaled corticosteroid Budesonide are the 2 arms of the study currently. As cases of COVID-19 in the region rise, the research team urges teams to continue to promote the study and consider re-sending text messages out to potentially eligible participants. Adverts have also recently been placed in local press to try to raise the profile of the study in the region, and poster are up at local testing sites. Anyone experiencing COVID-19 symptoms, which started within the last 14 days may be eligible to join the PRINCIPLE trial if they are aged over 65; or over 50 with an underlying health condition. RECAP (REmote Covid Assessment in Primary Care) – a study aiming to developing a tool to assist primary care providers in the identification of those COVID-19 patients at risk of becoming severe, in order to facilitate the rapid escalation of their treatment and increase the chances of better outcomes. A number of GP practices in Eastern region have been accepted onto the study. The study is still open for expression of interest from more practices. NHS Check aims to establish a cohort of NHS-affiliated staff to investigate the short, medium and longer term psychosocial impact of the COVID-19 pandemic on staff performance and wellbeing. The study is recruiting across 5 Eastern Trusts, including East Suffolk and North Essex NHS Foundation Trust Staff based at those sites can join the NHS Check study at https://nhscheck.org/ to complete a short 5 minute survey (and enter a free prize draw to win a coffee machine for their team!) What's the STORY? The Oxford Vaccine Group study is investigating the serological profile of children and young adults to assess how well the population is protected from vaccine preventable disease. This study will involve blood sampling from people aged from birth to 24 years of age to look at their antibody levels against important infectious diseases (with particular interest in Group C meningococcus (MenC), diphtheria and COVID-19. This will
help researchers understand whether any changes might be needed to the UK vaccine
schedule, and give additional data on COVID-19 infections in the UK. The study opened at
West Suffolk Hospital - recruitment will begin following a central study invitation mail out.
Other news of interest:
Read how the asymptomatic screening programme and the collaboration with researchers at
the COVID-19 Genomics UK Consortium (COG-UK) helped Cambridge University
understand and limit the spread of SARS-CoV-2 among its students.
Read about the opportunities and challenges community nursing faces in continuing to
provide end-of-life care during COVID-19.
The tables below give an overview of all COVID-19 research activity across Suffolk.
Please note that this information is provided for reference only and not for external
publication.
Primary Care Studies
Study Title Study aim Study Local status Recruitme
settin nt[1]
g
1 Principle: Platform randomised To test Primar Sites NEE: 48 across
. trial of Interventions against different y Care activate Colches Suffolk
Covid-19 with older people medications to d: ter &NEE
https://www.phctrials.ox.ac.uk see whether Suffolk: Medical practices
/principle-trial this reduces The Practice
the need for Peninsul Castle Nationally:
hospitalisation a Garden 3,678
or will speed Practice; s
up recovery in The Two Medical
older patients Rivers; Centre;
(65+ or 50-64 Victoria Parsons
with a pre- Surgery Health
existing The Medical
condition) Christma Centre;
hydroxychloro s Shrub
quine – Maltings End
recruitment & Surgery
paused Clement ;
Azithromycin – s Wimpol
recruitment Practice e Rd
started Chesterfi Surgery
Other eld Drive ;
medications Haven Great
may be added Health Bentley
to the trial at a Derby Surgery
later point. Road Ambros
e Group
[1]
Data collected from national research database – figures may lag behind actual figuresArdleig
h
Colne
Medical
Practice
West
Mersea
Rowhe
dge
Riversid
e
2 FLU-CATS: Evaluation and An Primar Awaiting revised Not yet set
. refinement of pandemic observational y care protocol for up
influenza community study of COVID-19
assessment tools pandemic
influenza
community
assessment
tools which is
being amended
to pick up
COVID-19
patients
3 VIVALDI COVID-19 in care An Care 3 care homes in North
. homes observational Home Suffolk / NEE are Court Care
study to s signed up. Home: 26
understand Catchpole
SARS-COV-2 Court Care
infection Home: 36
immunity and Kingfisher
its duration in House
care home staff Care
and residents Home: 50
in the uk
Local
recruitme
nt – 26
Nationally:
3,760
4 RECAP (REmote Covid This research GPs Being set up across No recruits
. Assessment in Primary Care). aims to and UK and Eastern showed
develop a practic yet
score for GPs es
to use when
assessing how
badly a patient
is affected with
COVID, to use
over the phone
or by video.Cross Sector Studies
Study Title Study aim Study Local Recruitmen
setting status t[2]
1 Chloroquine prevention The aim of the study is to Secondary East MHRA
of coronavirus disease determine if Care Suffolk approved
(COVID-19) in the hydroxychloroquine but with and North study to
healthcare setting; a prophylaxis prevents the Essex NHS restart
randomised, placebo- symptomatic COVID-19 expectatio Foundatio
controlled prophylaxis infection in front-line health n that n Trust Nationally
study (COPCOV) care workers. frontline selected recruited:
http://copcov.org/ workers to 88
across all participat
health and e;
social care
sectors WSH in
would be set-up
able to
take part
as
participan
ts
2 CROWN The aim of the study is to Secondary ESNFT Not yet set
. CORONATION Chloroq determine the effectiveness Care but expected up
uine Repurposing to of with the to take
healthWorkers for chloroquine/hydroxychloro expectatio part
Novel Coronavirus quine prophylaxis in n that
mitigation preventing symptomatic frontline
Study being amended COVID-19 in healthcare workers
to look at other workers at risk of SARS- across all
prophylactic treatments CoV-2 exposure. health and
instead of chloroquine / social care
hydroxychloroquine sectors
would be
able to
take part
as
participan
ts
3 Virus Watch An observational study into All sectors Colcheste Colchester
. understanding community expected r Medical Medical
incidence, symptom to be Practice Practice: 79
profiles, and transmission involved Howard Howard
of COVID-19 in relation to in House House
population movement and collection Surgery Surgery: 23
behaviour. of serum Oakfield Leiston
samples Surgery Surgery: 71
for Stowhealt Oakfield
participati h Surgery: 22
[2]
Data collected from national research database – figures may lag behind actual figuresng The Stowhealth:
household Chesterfie 84
s in Part 2 ld Drive The
of the Practice Chesterfield
study. Drive
Part 1 is Practice: 75
managed
centrally Nationally
recruited:
46,226
4 Multi-centre EuRopean An observational study aims This study Trusts Not yet set
. study of MAjor to identify host and will enrol invited for up
Infectious Disease pathogen related participan expressio
Syndromes determinants of severity of ts in both n of
(MERMAIDS): Acute community acquired acute primary interest Nationally:
Respiratory Infections respiratory infections in care and 47
in Adults adults. secondary
care.
5 Behavioural Activation This study is part of the Looking Trusts Not yet set
. in Social Isolation MODS (Multi-Morbidity in for Trust invited for up
(BASIL-C19) Older adults with sites; with expressio
Depression Study) potential n of
programme, looking at cross- interest
whether a talking treatment sector
called Behavioural involveme
Activation (BA) can help nt with
improve a person’s physical primary
and psychological care
functioning, for example
self-care and mood. The
study is asking ‘can we
prevent or ameliorate
depression and loneliness in
older people with long term
conditions who are under
enforced COVID-19
isolation?’.
6 Post-hospitalisation The aim is to understand TBC TBC Not yet set
. COVID-19 study: a and improve long-term up
national consortium to outcomes for survivors of
understand and hospitalisation with COVID-
improve long-term 19. The PHOSP-COVID study
health outcomes is aligned to the clinical
(PHOSP-COVID) follow-up provided, but
does not alter clinical care.
7 Psychological Impact of A survey to explore the Advertised Norfolk & NSFT: 104
. COVID-19 psychological impact of though Suffolk
COVID-19 outbreak and the social NHS
resultant restrictions in media via foundatio
terms of behavioural, local n Trust
(NSFT)N.B. the study adopted emotional and social Trusts and
on NIHR portfolio but factors. CCGs
not badged with urgent
public health status
8 Novavax COVID 12-month placebo Study ESNEFT; ESNEFT: 168
. Vaccine study – A trial controlled trial to evaluate based at recruitme
to evaluate SARS-CoV-2 the safety and efficacy of ESNEFT nt Nationally:
Recombinant the Novavax Vaccine in and complete 15,203
Nanoparticle vaccine adults 18-84. supported d
by Primary
Care team
Secondary Care Studies
Study Title Study aim Study Local Recruitm
setting status ent[3]
1. RECOVERY: Randomised Evaluation of To test if Second Open WSH: 86
COVID-19 Therapy existing or ary sites: Ipswich
new drugs can care; ESNEFT Hospital:
help patients (Paedia (Ipswic 186
hospitalised tric h and
with and Colches Nationally
confirmed neonat ter) : 24,045
COVID-19; al arm WSH
The UK New to be
and added
Emerging soon)
Respiratory
Virus Threats
Advisory
Group
(NERVTAG)
advised that
several
possible
treatments
should be
evaluated,
including:
Lopinavir-
Ritonavir(arm
closed-shown
no clinical
benefit; read
more here),
Interferon β,
corticosteroid
s[4], and
[3]
Data collected from national research database – figures may lag behind actual figures
[4]
Corticosteroids used in the trial are expected to be sourced by local pharmacy procurement team via their
normal routes, all other medications for RECOVERY sourced centrally via PHERemdesivir,
Hydroxychlor
oquine (arm
closed; read
more here),
Tocilizumab,
Dexamethaso
ne,
convalescent
plasma. Other
treatments
may soon
emerge that
require
evaluation.
The supply
arrangements
for each
medicine for
RECOVERY
trial are
described
here.
2 RECOVERY-RS (Respiratory support) This study is Second Open ESNEFT:8
aiming to ary sites:
https://warwick.ac.uk/fac/sci/med/research/ determine if care Ipswich Nationally
ctu/trials/recovery-rs/ CPAP Hospita : 903
(continuous l
positive Colches
airway ter
pressure) or WSH
HFNO (high
flow nasal
oxygen) is
clinically
effective
compared to
standard care
(excluding
CPAP or
HFNO).
3. Re-MAP Cap: Randomized, Embedded, The trial will Second All sites ESNEFT:3
Multifactorial, Adaptive Platform trial for look at a ary running 0
Community-Acquired Pneumonia number of care/IC RECOV
https://www.remapcap.org/ different Us ERY Nationally
treatment study : 3,583
categories are
with an aim to invited
determine the to
best clinicallyeffective particip
treatment for ate
adult patients
with CAP
admitted to
participating
intensive care
units with
suspected or
microbiologic
al testing
confirmed
COVID-19
infection.
4. CCP-UK Clinical Characterisation Protocol for An Second All ESNEFT:
Severe Emerging Infection' study/(ISARIC-4C) observational ary acute 1935
study care Trusts WSH: 803
collecting in the
samples and Eastern Nationally
data from region : 155,046
confirmed activate
COVID-19 d;
patients
5. UKOSS: Pandemic Influenza in Pregnancy An Second Open No
https://www.npeu.ox.ac.uk/ukoss/current- observational ary sites: recruitme
surveillance/covid-19-in-pregnancy study via the care / Colches nt data
UK Obstetric Trusts ter; showing
Surveillance with Ipswich
System to Matern hospita
collect ity ls;
information Units WSH
on pregnant
women
admitted to
hospital with
confirmed
COVID-19
6. GenOMICC Genetics of susceptibility and An Second Ipswich Ipswich
mortality in critical care observational ary Hospita Hospital:
study to care l open 48
identify the WSH WSH:1
specific genes reviewi
that cause ng
some people Nationally
to be : 8,472
susceptible to
specific
infections and
consequences
of severe
injury.7. Coronavirus infection in primary or An Second Not Recruitm
secondary immunosuppressed children. observational ary open to ent now
study care new complete
designed to sites
allow families current
of ly Nationally
immunosuppr recruited:
essed children 1,633
and young
people to self-
record their
experiences of
COVID-19 and
other viral
respiratory
illnesses
during the
COVID-19
epidemic.
8. PAN COVID : Pregnancy and Neonatal A global Second Open ESNEFT:
Outcomes in COVID-19 registry of ary sites: 32
https://pan-covid.org/ women with care WSH West
suspected or ESNFT Suffolk:3
confirmed (Ipswic
SARS-CoV-2 h& Nationally
infection in Colches : 5,500
pregnancy ter)
and their
neonates,
understanding
natural
history to
guide
treatment and
prevention
9. Neonatal Complications of Coronavirus This is a Second Open There will
Disease (COVID-19) Study national ary sites: be no
surveillance care WSH consentin
programme g (no
using the recruits)
standard for this
British study as
Paediatric linked to
Surveillance another
Unit (BPSU) study
approach.
This study will
run alongsideand be cross-
linked with
the maternal
surveillance
study run
through the
United
Kingdom
Obstetric
Surveillance
System
(UKOSS;
CPMS:
14162), which
is already in
progress.
1 TACTIC-R (Multiarm Therapeutic study in The TACTIC-R Second Several WSH: 10
0. pre-ICU patients admitted with COVID-19 - clinical trial is ary sites in
Repurposed Drugs) testing care Eastern
whether are Nationally
existing drugs, being recruited:
which are set up 290
already used
to treat other Opene
immune- d sites:
related WSH
conditions,
can prevent
the
development
of severe
symptoms in
patients
hospitalised
with
confirmed/str
ongly
suspected
COVID-19.
This
approach,
known as
repurposing,
is a way of
finding out
whether
existing
therapies,
which are
likely to bereadily
available in
hospitals, are
effective in
treating the
disease.
1 SIREN: Sarscov2 Immunity & REinfection An Second Current WSH: 484
1. EvaluatioN - The impact of detectable anti observational ary ly is ESNEFT:
SARS-COV2 antibody on the incidence of study which care being 350
COVID-19 in healthcare workers aims to find set up
out whether in
healthcare second
workers who ary
have evidence care – Nationally
of prior all recruited:
COVID-19 trusts 31,485
infection, expecte
detected by d to
antibody take
assays part as
(positive part of
antibody Trust
tests), wide
compared to antibod
those who do y
not have screeni
evidence of ng
infection process
(negative es
antibody
tests) are Open
protected sites:
from future WSH
episodes of ESNEFT
infection. For
SARS CoV2
infection it is
not yet known
if the
detection of
antibodies
protects
people from
future
infection. This
study aims to
provide this
very
important
information,
which willhelp to
understand
the future
impact of
COVID-19 on
the
population.
1 NHS CHECK: Health & Experiences of staff Aims to Second Open ESNEFT:
2 working at NHS Trusts and Nightingale establish a ary sites: 425
Hospitals cohort of care ESNEFT
https://www.kcl.ac.uk/news/nhs-check- NHS-affiliated Nationally
study-to-explore-the-effect-of-the-covid-19- staff to recruited:
pandemic-on-nhs-staff investigate 25,694
the short,
medium and
longer term
psychosocial
impact of the
COVID-19
pandemic on
staff
performance
and
wellbeing.
NHS staff will
be invited to
participate, to
complete an
online survey
module and
an
intervention
evaluation
module
What's the STORY? This Oxford Second Opene No
Vaccine ary d at: recruitme
Group study is care West nt shown
investigating Suffolk yet
the Hospita
serological l
profile of
children and
young adults
to assess how
well the
population is
protected
from vaccine
preventable
disease. This
study willinvolve blood
sampling from
people aged
from birth to
24 years of
age to look at
their antibody
levels against
important
infectious
diseases.
5
Local update
A full list of all DHSC priority COVID-19 studies can be found at https://www.nihr.ac.uk/covid-
studies/
Gosia Majsak-Newman
Research & Development Officer/ NIHR GCP Facilitator
Norfolk and Suffolk Primary and Community Care Research Office
NHS Norfolk and Waveney Clinical Commissioning Group | Lakeside 400, Broadland Business Park |
Norwich NR7 0WG |
Mobile: 07552 008271
E-mail: g.majsak-newman@nhs.net
Team email: nwccg.RandDoffice@nhs.net
Website: http://nspccro.nihr.ac.uk
Follow us on Twitter @NHS_NSResearch
The Norfolk & Suffolk Primary & Community Care Research Office at NHS Norfolk and Waveney
CCG undertakes research management, design and delivery services for Primary and Community
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