As part of the national response to Covid-19 we are pleased to be supporting important research being led locally and nationally to understand more about the infection and its impact.
NHS Trusts were asked to prioritise research studies that were badged as urgent public health studies. Below is a list of studies we have run or continue to run in response to covid-19. Please see the open studies for opportunities of how you can take part.
By September 2021 Sheffield Children’s NHS Foundation Trust had contributed over 1,700 participants to the studies below! Many thanks to all our staff, patients and friends and family who have taken part and continue to take part in these important studies.
The PRIEST Study (Pandemic Respiratory Infection Emergency System Triage) - Closed
Sponsored by Sheffield Teaching Hospitals
Urgent public health study: Yes
During a pandemic, more patients attend hospital services and require investigation or admission, which puts a huge strain on the NHS.
The study aims to optimise the triage of people using the emergency care system (111 and 999 calls, ambulance conveyance, or hospital emergency department) with suspected respiratory infections during a pandemic and identify the most accurate triage method for predicting severe illness among patients attending the emergency department with suspected respiratory infection.
Can I take part?
This study has now closed to recruitment nationally. If your child attended the Emergency Department before June 2020 and was suspected of having covid-19 we will have collected some anonymised data from clinical records for this study. At Sheffield Children’s Hospital we contributed data from nearly 500 attendances for this study. The study team have produced a number of publications that have increased our understanding about COVID-19. See the link below.
The What’s The Story Study - Serum Testing of Representative Youngsters - Closed
Sponsored by University of Oxford
Urgent public Health Study: Yes
Public Health England has an ongoing sero-prevalence programme to assess how well the population is protected from vaccine preventable diseases. The current way to check this is by testing left-over blood samples from different healthcare laboratories around the country and examine them to see what protection they have from vaccine preventable diseases. There are two problems with this system. Firstly samples may not be representative of the general population particularly in younger age groups and secondly we do not know which vaccines the patients who provided the samples have received.
The study will assess the feasibility of establishing a national sero-epidemiological survey in England in individuals aged 0 – 24 years. We will be focusing initially on COVID 19, Diphtheria and Group C invasive meningococcal disease. Each participant will have the study explained to them and if they give consent they will be asked to provide one blood sample and answer a short questionnaire. These samples will then be analysed in a Public Health England laboratory to see if the participant has evidence of immunity against these diseases.
Can I take part?
Recruitment has now closed to this study (May 2021).
Many thanks to the 123 young people from around Sheffield who took part in this study. We look forward to seeing the results of this study in coming months.
If you expressed interest but were not recruited, please see the comment below:
Thank you for your previous interest in the What’s the STORY study. We would to inform you that recruitment to this study is closed and we will no longer be holding your response on file.
The Coronavirus Infection in Primary or Secondary Immunosuppressed Children - Closed
Sponsored by University Hospital Southampton NHS Foundation Trust
Urgent Public Health Study: Yes
This study is designed to allow families of immunosuppressed children and young people to self-record their experiences of COVID-19 and other viral respiratory illnesses during the COVID-19 epidemic. Parents of immunosuppressed patients and young people aged 16-17 yrs who are immunosuppressed will be provided with online information and asked to fill in online questionnaires at baseline and weekly thereafter. Information collected will include immune-system affecting medication, symptoms, contact with health care providers, test results and impact on daily activities. Data will be collected and analysed weekly to be able to monitor any potential risk factors for severe disease.
Can I take part?
This study has also closed but many thanks to all the volunteers from Sheffield Children’s Hospital who have taken part. We expect the study team to be posting results about this study on their website below
SIREN (Sarscov2 Immunity & REinfection EvaluatioN): The impact of detectable anti SARS-COV2 antibody on the incidence of COVID-19 in healthcare works - Closed
Sponsored by Public Health England
The purpose of this study is to understand whether prior infection with SARS-CoV2 (the virus that causes COVID-19) protects against future infection with the same virus.
COVID-19 is caused by a virus, called SARS-CoV2, and the main way we diagnose infection with this virus is to take a swab from a person’s nose (and sometimes throat too) and look for presence of genetic material from the virus. Once someone has recovered from the infection, the live virus should no longer be present in the nose or throat. One way the body fights infections like COVID-19 is by producing small particles in the blood called “antibodies”, which can be detected using a blood test. It takes days or weeks for the body to make enough of these antibodies to fight the infection. When someone gets better, these antibodies can remain in their blood at low levels, and may help protect against future infections with the same virus. By doing both swab and blood tests together, regularly over time we will be able to assess whether prior infection (measured through an antibody test) protects against future infection (measured through detection of virus on a swab test).
We will also improve our understanding of other important areas:
The blood tests will allow us to understand the number of healthcare workers infected by COVID in the last few months and allow us to understand whether there are differences related to age, ethnicity and other factors.
By taking regular samples (both swabs and blood), we can measure what proportion of frontline NHS staff are exposed to SARS-CoV2 and improve our understanding of how quickly it spreads over the coming months.
By taking blood samples we will understand how an individual’s antibody levels change over time and the different types of antibodies that may be present.
We will also investigate how viruses from different individuals relate to each other by comparing the genetic make-up of the viruses.
Where participants are swab positive several times we will seek to understand how infectious they might be through attempting to grow (culture) the virus from their samples and explore the changes in the virus genetic material.
If individuals are admitted to hospital, we will explore how individual characteristics and virus factors may impact on their illness.
Can I take part? This study is closed. Many thanks to the 321 staff who have already taken part and those who continue to do so.
Psychological impact of the Coronavirus (COVID-19) pandemic and experience: An international survey - Closed
Sponsored by Southern Health NHS Foundation Trust
Researchers from a collaboration group would like to invite you to take part in a short questionnaire exploring the psychological impact of the coronavirus, its effect on our emotions, behaviour and wellbeing. This is the second phase of recruitment. If you took part in the first phase of the study, you are still able to take part in this second phase, conversely if you did not take part in first phase; you are still able to take part in this second phase.
The aim of this survey is to better understand how the coronavirus pandemic and resultant restrictions/lockdown are affecting our day to day lifestyle. We hope to find out what is helpful for people during this time and also what may be causing some people to be affected more than others in terms of their wellbeing.
Can I take part?
This study has now closed. Many thanks to the 500+ participants who took part in this study.
ISARIC- CCP – WHO Clinical Characterisation Protocol for Severe Emerging Infection - Open
Sponsored by University of Oxford
Urgent Public Health study: Yes
There is an urgent need to conduct coordinated clinical research in the early phase of this dynamic development to know more about this virus and to provide an evidence base to inform treatment decisions and an effective public health response. This study is designed for the rapid, coordinated clinical investigation of patients with confirmed novel coronavirus infection. The study has been designed to maximize the likelihood that as much data as possible is collected and shared rapidly in a format that can be easily analysed across many different settings globally.
The purpose of the CCP-UK is to study COVID-19 disease to better understand its spread and behaviour by analysing biological samples and data from patients with confirmed cases of the disease across the UK.
Can I take part?
If you or your child is admitted with covid-19 we will be collecting anonymised information about the admission for this study. We are no longer collecting biological samples (such as blood and urine) so we won’t need to come and speak to you about taking part
Randomised Evaluation of COVID-19 Therapy: the RECOVERY trial - Open
Sponsored by University of Oxford
A range of potential treatments have been suggested for COVID-19 but nobody knows if any of them will turn out to be more effective in helping people recover than the usual standard of hospital care which all patients will receive. These treatments have been recommended for testing by the expert panel that advises the Chief Medical Officer in England. Some are tablets and some are injections. Although these treatments show promise, nobody knows if any of them will turn out to be more effective in helping patients recover than the usual standard of care at your hospital (which all patients will receive).
The RECOVERY Trial is currently testing some of these suggested treatments:
Anakinra (a drug commonly used in hyperinflammation)
Baricitinib (anti-inflammatory drug currently used in Rheumaotology)
Tocilizumab (an anti-inflammatory treatment given by injection)
REGn-COV2 (a combination of monoclonal antibodies directed against coronavirus)
Data from the trial will be regularly reviewed so that any effective treatment can be identified quickly and made available to all patients. The RECOVERY Trial team will constantly review information on new drugs and include promising ones in the trial.
Can I take part?
You may be also to take part in this trial if you have COVID-19 confirmed by a laboratory test for coronavirus (or considered likely by your doctors), and are in hospital. Patients will not be included if the attending doctor thinks there is a particular reason why none of the study treatments are suitable.
Diagnosis and Management of Febrile Illness using RNA Personalised Molecular Signature Diagnosis - DIAMONDS - Open
Sponsored by Imperial College London
Patients come to hospitals every day with common symptoms, such as fever, which suggest that they have a virus or bacterial infection. However, in some cases there may be no infection present, even though the symptoms are similar – for instance in inflammatory illnesses. When different illnesses have similar symptoms, it can be difficult to make a diagnosis accurately and quickly. This means that optimal treatment may be delayed.
The study team want to design new diagnostic tests based on a blood test that can tell us quickly and accurately what illness a patient has when they come to hospital with common symptoms such as fever. This would help us give the right treatment to the right patient, at the right time.
The study has received urgent public health status and if now focussed on recruiting patients admitted with COVID-19 and other illnesses to understand more about COVID-19.
Can I take part?
If you or your child is admitted to the hospital with confirmed covid 19 or suspected COVID-19 and having a blood test we will come and talk to you about taking part in this study. Taking part in the study will involve providing some additional samples (such as blood and urine) for research when the tests are already being undertaken by the clinical teams.
GenOMiCC Study - The Genetics of Susceptibility and Mortality in Critical Care - Open to patients on paediatric intensive and critical care
Sponsored by NHS Lothian
Urgent Public Health Study: Yes
This is a research study that looks at the DNA of people with severe infections and injuries. Infectious diseases and severe injuries affect millions of people around the world every year. Most cases are mild, but some people become very unwell and are admitted to intensive care. Our genes (DNA) can determine how much critical illness affects us. We want to find the genes that cause some people to be more sick. If we do, we may be able to develop better treatments for patients in the future. To do this, researchers will compare DNA and cells from carefully selected patients with samples from healthy people.
Can I take part?
Only patients admitted to the paediatric intensive and critical care will be eligible for the study at present.
Comparing COVID-19 Vaccine Schedule Combinations in adolescents (Com-COV3) - On hold
Sponsored by University of Oxford
What is the purpose of this study?
The purpose of this study is to find out how well young people (aged 12-16 years) respond to two doses of COVID-19 vaccine. We will compare three different vaccines at different doses.
We want to find out if giving two doses of different vaccines produces as good an immune response as giving two doses of the same vaccine, in young people.
Can I take part?
Recruitment for this study is currently on hold due to changes in the national immunisation strategy in light of the Omicron variant. We hope to start this trial again in 2022.
Our Research and Innovation Department is dedicated to the development of medicines and treatments for children, and innovating in children’s healthcare is a key priority for the Trust.
Our research strengths cover a wide range of clinical specialties and we are proud to work with some of the country’s leading professionals in paediatric conditions.
The Sheffield Children’s Clinical Research Facility (CCRF) opened in 2008 and was the first paediatric clinical research facility in the UK.
Research and Innovation at Sheffield Children’s NHS Foundation Trust includes the Research Administration and Governance Team and the Clinical Research Facility Team. Together we provide comprehensive assistance to researchers conducting clinical research in our Trust.
We work closely with colleagues in the NIHR CRN: Yorkshire and Humber, regional NHS trusts and our local universities to ensure that we provide a streamlined service for the development, set-up, costing and management of both paediatric and adult research conducted at Sheffield Children’s NHS Foundation Trust.
Health Research Authority
The Health Research Authority and the Government set standards for all NHS organisations to make sure we protect your privacy and comply with the law when we are involved in research. They review all research studies to make sure that the research uses of personal data are in the public interest and meet ethical standards.
NIHR Children’s and Young People’s Med Tech Cooperative
Sheffield Children’s hosts the NIHR (National Institute for Health Research) Children and Young People MedTech Cooperative (NIHR CYP MedTech), a national consortium that supports and accelerates the development and adoption of child health technology in the NHS. NIHR CYP MedTech is one of the 11 MedTech and In vitro diagnostics Co-operatives (MICs) funded by the NIHR and is the only MIC supporting children and young people. The network supports 7 specialty themes supported by NHS Trusts across the country focussed on addressing unmet health needs with technology solutions. For more information visit http://www.cypmedtech.nihr.ac.uk
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