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National priority coronavirus (COVID-19) research

Patients receiving treatment within our coronavirus (COVID-19) wards and our intensive care unit, and their families, may be approached about taking part in national priority COVID-19 studies.

You can help support COVID-19 vaccine research by signing up to be contacted about opportunities to take part in vaccine research studies through the NHS and NIHR national registry.

In order to make sure of the rapid delivery of COVID-19 clinical trials and research studies, a new national approval structure was introduced in 2020. This national approvals group provided urgent public health badging of clinical trials and research studies and subsequent approval by the chief medical officer.

Our research

The following studies are now open within the Trust.

  • Understanding COVID-19

    C-MORE capturing multiorgan effects of COVID-19

    Although COVID-19 mostly affects the lungs, some people can develop damage to other organs. The symptoms of COVID-19 can continue for months after the infection. The purpose of this study is to understand the effects of COVID-19 on the health of the:

    • lungs
    • heart
    • brain
    • liver
    • kidney

    It will assess how it has affected people's quality of life, mental health and exercise capacity 12 months after the infection, and compare them with people who have not had COVID-19.

    Find out more about the C-MORE study on the NIHR website.

    Impact of biologic therapy on COVID-19 infection and immunity (CLARITY)

    Inflammatory bowel disease (IBD) affects about 1% of the UK population and is usually treated with immunosuppressive drugs. The impact of immunosuppressive drugs on COVID-19 infection and disease severity is unknown but is a concern for patients and clinicians.

    This study will provide evidence for safer prescribing of immunomodulator and biologic drugs during COVID-19 and inform public health policy regarding physical distancing measures, and future vaccination strategies.

    Find out more about the biologic therapy study on the NIHR website.

    COVID-19 identification of epitopes and antibodies (COVID-IDEA)

    Visit the NIHR BioResource website for information about the COVID-IDEA study.

    GenOMICC

    Our genes determine how likely we are to get life-threatening infections, and when a patient is already sick, different genetic factors determine how likely they are to survive. The GenOMICC (genetics of susceptibility and mortality in critical care) study will identify the specific genes that cause some people to be more likely to get particular infections and more likely to end up being severely ill.

    Identifying these genes may help us to use existing treatments better, and to design new treatments to help people survive serious illness. To do this, we will compare cells and DNA (the genetic code that determines all of a person's characteristics found in the cell nucleus) from carefully selected patients with those from healthy people. The study, which started in 2016, will include COVID-19 patients.

    ISARIC-4C

    There is an urgent need to conduct coordinated clinical research in the early phase of this dynamic development to know more about coronavirus (COVID-19) and to provide an evidence base to inform treatment decisions and an effective public health response. The Clinical Characterisation Protocol for Severe Emerging Infection (ISARIC-4C) 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 aggregated, tabulated and analysed across many different settings globally. The study is designed to have some level of flexibility in order to ensure the widest acceptance.

    Post-hospitalisation COVID-19 study: a national consortium to understand and improve long-term health outcomes (PHOSP-COVID)

    The COVID-19 pandemic has had a major impact on the UK's health, social care and economy. This study will investigate the chronic health and health economic effects of COVID-19 infection in post-hospitalisation survivors.

    The study will have 10,000 participants and will continue to link to participants clinical data for at least 25 years or until the patient has deceased or withdrawn consent.

    Find out more about the PHOSP-COVID study on the NIHR website.

  • Testing new treatments

    HEAL-COVID trial

    This study will assess several different treatments that may reduce or prevent the long-term complications of COVID-19. Participants will be recruited from hospitals in the UK. Adults with COVID-19 and an expected hospital discharge within 5 days will be able to take part in the study. 
    Participants will be randomly assigned one of the study treatments or standard of care and will take part for 12 months. Information will be collected from their updated health records, as well as remotely entered patient reported data and quality of life assessments..

    Find out more about the HEAL-COVID trial on the NIHR website.

    ILIAD-7

    The ILIAD-7 study's goal is to successfully trial CYT107 on COVID-19 patients as part of a global effort to treat the disease. IL-7 (CYT107) may prevent patients who are in the hospital for COVID-19 from progressing to having to be treated in the ICU. A Phase II randomized clinical trial is in the process of regulatory submission, building upon the prior and ongoing clinical trials of CYT107.

    Phase III trial of inhaled anti-viral (SNG001) for SARS-CoV-2

    Find our more about the inhaled anti-viral trial on the NIHR website.

    RECOVERY

    RECOVERY is a randomised trial among adults hospitalised for confirmed coronavirus (COVID-19). Eligible patients are randomly allocated between several treatment arms, each to be given in addition to the usual standard of care in the participating hospital: no additional treatment vs Lopinavir-Ritonavir vs Interferon β1b vs low-dose corticosteroids. For patients for whom not all the trial arms are appropriate or at locations where not all are available, randomisation will be between fewer arms.

    The main outcomes will be in-hospital death, discharge, and need for ventilation. For the main analyses, follow-up will be censored at 28 days after admission. Additional information on longer term outcomes may be collected through review of medical records or linkage to medical databases such as those managed by NHS Digital and equivalent organisations in the devolved nations.

    REMAP-CAP

    REMAP-CAP is an international platform trial that has been specifically designed for a pandemic period. The aim is to generate evidence that can be applied during the pandemic to reduce mortality, reduce intensive care use, and reduce morbidity in severely ill patients with coronavirus (COVID-19) infection. The platform will test multiple treatments at the same time (antivirals, immune modulation drugs and corticosteroids) and more treatments will be added as new evidence emerges. If a treatment is beneficial, more patients will be treated with that drug within the trial, improving outcomes and reducing ICU stays, even before the results are declared and the trial ends. It provides a type of self-learning healthcare system, which is important in this fast-moving pandemic.

  • Children and pregnant women

    Coronavirus infection in immunosuppressed children

    The coronavirus infection in immunosuppressed children study is designed to allow families of immunosuppressed children and young people to self-record their experiences of coronavirus (COVID-19) and other viral respiratory illnesses during the coronavirus (COVID-19) epidemic. Parents of immunosuppressed patients, and young people aged 16-17 years 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. This study is complementary to, and not overlapping with, the global ISARIC World Health Organisation protocol that will be studying coronavirus (COVID-19) cases admitted to all NHS Trusts, including all children.

    Neonatal complications of coronavirus disease

    So far we have very little information about how COVID-19 affects mothers and newborn babies and it is not clear how best to care for mothers and babies affected. We have very little information about how babies get COVID-19, whether it transmits from mothers to their baby(s) while they are still pregnant, during labour and birth, or whether the infection occurs following birth. Understanding this will mean that we can give the best care to mothers and babies and the best advice to pregnant women about the effects of COVID-19 on their baby.

    This study will collect information about newborn babies who have COVID-19 or who are born to mothers who have Coronavirus. The information we collect will help us to understand:

    • how babies get COVID-19
    • what happens to babies when their mother has COVID-19
    • What treatments are effective in helping babies with COVID-19 to get better
    • What happens to babies when they have been treated.

    We are carrying out the study through the British Paediatric Surveillance Unit (BPSU) system. Each week, every doctor across the UK looking after newborn babies in hospital will be asked by the BPSU if they have looked after a newborn baby with COVID-19 or whose mother has COVID-19. If they have, they will be sent a questionnaire to collect information about the baby and their mother. As this information about all affected babies is urgently needed, we will not be asking parents for consent to include their baby's information in the study, although parents will be able to opt out.

    Pregnancy and neonatal outcomes in COVID-19

    This study aims to better understand how COVID-19 affects early pregnancy, fetal growth, prematurity and virus transmission to the baby. The study will examine data from women with suspected and confirmed COVID-19 from early pregnancy to after delivery of the baby.

    Find out more about the pregnancy and neonatal outcomes study on the NIHR website.

    UKOSS

    This NIHR supported study is a national study of women hospitalised with confirmed COVID-19 in pregnancy. The study, funded by the NIHR, will use the UK Obstetric Surveillance System (UKOSS) to collect information about all pregnant women admitted to hospital who are confirmed to have the virus infection. The information will be analysed on a continuous basis to inform ongoing guidance for women and maternity staff as we respond to the pandemic. More specifically, the study will describe incidence, management and outcomes of COVID-19 in pregnancy and identify factors associated with better outcomes for women and their babies.

    Anonymous information will be collected through the existing UK Obstetric Surveillance System (UKOSS) reporters, who are based in all maternity units in the UK. Reporters have been sent a live link to allow them to notify cases and complete an anonymous data collection form.

  • Diagnosing COVID-19

    DIAMONDS

    The overall aim of DIAMONDS is to design new diagnostic tests that can tell quickly and accurately what illness a patient has when they come to hospital with common symptoms, such as a fever. This would help the right treatment to be given to the right patient, at the right time. This is called 'personalised medicine'. The diagnostic device is called 'personalised medicine signature device' (PMSD).

    There are four parts to DIAMONDS:

    1. DIAMONDS Search, whose aim is to find RNA signatures in blood from patients with infectious and/or inflammatory conditions.
    2. Establishment of the European Diagnostic Transciptomic Library to enable analysis of molecular taxonomy of infectious and inflammatory disease which will be used as the basis for personalised diagnosis.
    3. Development and configuration of devices to rapidly detect gene transcripts required for PMSD and evaluation on improved patient diagnosis and treatment.
    4. Evaluation of performance of diagnostic devices in prospective recruitment of patients and controls in the DIAMONDS Pilot Demonstration. The impact of the implementation of the devices will be also evaluated.

  • Public health

    COG-UK HOCI study

    Hospitals are recognised to be a major risk for the spread of infections despite the availability of protective measures. The health impact of hospital infection is greatest in vulnerable patients. COVID-19 presents an additional, significant health risk to healthcare workers.

    The study will examine infection, prevention and control (IPC) data from NHS hospitals to find out whether genome sequencing more effectively reduces infection rates within hospitals and may help identify the routes of transmission. 

    Find out more about the COG-UK HOCI study on the NIHR website.

  • Preventing COVID-19

    PROTECT V PROphylaxis for paTiEnts at risk of COVID-19 infecTion

    The PROTECT clinical trial aims to enrol patients at particularly high risk of COVID-19 and its complications, seeking to test the use of nasal nicolosamide treatment as a prophylactic measure that either might prevent the disease from occurring or may reduce the number of cases where the disease becomes serious or life-threatening.

    PROTECT is a randomised, double blind, placebo controlled event driven trial. Patients will be eligible for recruitment to the trial if they fall within one of the following vulnerable populations:
    a)patients receiving dialysis
    b)kidney transplant patients
    c)patients with vasculitis or glomerulonephritis.

    A total of 1500 participants will be randomised to active treatment or placebo, stratified by PROTECT sub-population, age and participating sites.

    Enrolment to the trial will be via an online platform following informed consent with a face to face screening visit. Subsequent assessments, aside from an in person end of trial visit, will be done via email or telephone together with utilising the routine collected health data thus reducing the burden to participants as well as reducing their exposure to COVID-19.