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National priority coronavirus (COVID-19) research

In order to ensure the rapid delivery of coronavirus (COVID-19) clinical trials and research studies a new national approval structure has been introduced. This national approvals group provides urgent public health badging of clinical trials and research studies and subsequent approval by the Chief Medical Officer.

Patients receiving treatment within our COVID wards and our Intensive Care Unit, and their families, may be approached about participation in national priority coronavirus (COVID-19) studies.

Our research

The following studies are now open within the Trust

  • GenOMICC

    Our genes determine how susceptible (likely to get) we are to life-threatening infection, 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.

  • COVID-19 – ACCORD-2

    The ACCORD clinical trials program brings together expertise of the Southampton National Institute for Health Research Biomedical Research Centre (NIHR BRC), NIHR Health Protection Research Unit for Emerging and Zoonotic Diseases, NIHR Respiratory Translational Research Collaboration, NIHR Southampton Clinical Trials Unit, Pharmaceutical companies, IQVIA and the NIHR Clinical Research Facility (CRF) network to enable the rapid development, conduct and reporting of clinical trials of candidate agents for the treatment of COVID-19. There are currently no approved therapeutic agents available to treat coronaviruses such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), the causative agent of COVID-19 disease, and there is an urgent public health need for rapid development of such interventions.

    This adaptive platform study is designed to rapidly assess multiple candidate agents as treatments for COVID-19. The master protocol outlines the overall structure of the study, including the population, inclusion and exclusion criteria, randomisation scheme, primary, secondary, and exploratory outcomes, study design, statistical methodology, and planned analyses that are common for all candidate agents to be tested. The master protocol is structured such that multiple candidate agents from different pharmaceutical companies can be evaluated simultaneously.

    The plan is to add candidate agents as they are identified, and to remove therapies once they have completed their evaluation. The sub-protocols will outline the scientific rationale, eligibility, treatment schema, and other specifics for each candidate agent. Study centres will be located in the United Kingdom. Overall, it is estimated that approximately 12 centres and investigators will initially take part in the study. It is estimated that up to 1,800 patients will participate in the overall study.

  • COVID-19 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.

  • TACTIC-R: Multiarm therapeutic study in pre-ICU patients admitted with COVID-19 – repurposed drugs

    While there are no current vaccines, prophylactic or therapeutic agents of proven efficacy for treating COVID-19, several medications licensed for patients with autoimmune disease can be used to prevent overactivation of the immune response in severe COVID-related disease. TACTIC is recruiting patients at an early stage in the disease course, aiming for a time point where the patient is experiencing infective symptoms and starting to show pulmonary complications. The purpose is to prevent organ damage and reduce the need to transfer to ICU and ventilation. The trial has two treatment arms and a comparator arm using the following drugs: baricitinib and ravulizumab.

    TACTIC trial aims to currently randomise COVID-19 positive patients into three arms, two active and one comparator. Arm one and two consists of baricitinib and ravulizumab respectively. Arm three consists of standard of care alone. Subjects are treated with their assigned regime during 14 days. Depending on the drug regimen they are assigned to, patients will either have 14-day dosing (baricitinib) or a single dose (ravulizumab). After the treatment phase, patients will have a 28 days and three month follow up. Patients will undergo blood testing as part of the routine care, and data relevant for the study will be taken from medical records whenever possible. Arms may be added or stopped depending on data and a recommendation from the independent data monitoring committee. The aim of this trial is to reduce the number of COVID-19 patients that will be admitted to ICU. Candidates: ravulizumab, baricitinib.

  • Investigating a vaccine against COVID-19 (COV002)

    There are no currently licensed vaccines or specific treatments for COVID-19. This study will enable us to assess how well people of all ages can be protected from COVID-19 with this new vaccine called ChAdOx1 nCoV-19. It will also give us valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus. We will enrol small numbers of older adults (56-70 years, then 70+ years) before expanding to large numbers of adults across all ages (18+ years). After this, we will also assess the vaccine in a small cohort of children (5-12 years). In total we will enrol up to 5,260 volunteers.

  • Pregnancy And neonatal outcomes for women with COVID-19 (PAN-COVID)

    The COVID-19 outbreak will affect thousands of pregnant women globally and evidence is currently limited on its impact on pregnancy and neonates.

    There is a need to rapidly collect clinical experience of COVID-19 in pregnancy and the neonates to inform the global community about the natural history of the disease and guide improvements in clinical care and public health. The PAN-COVID registry is centre-based and aims to offer a continuously updated collection of clinical case reports from around the world.

    Our research questions are to explore the experience of COVID-19 and:

    • miscarriage
    • fetal growth restriction and stillbirth
    • pre-term delivery
    • transmission from mother to baby.

    Modelling and opinion on the extent and peak of the outbreak suggests a broad time period over which the virus may impact on global populations. Our proposed registry will provide weekly feedback of data to the clinical community and will allow them to adapt their response based on the most the current information available.

  • 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.

  • Diagnosis and Management of Febrile Illness using RNA Personalised Molecular Signature Diagnosis (DIAMONDS Project)

    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 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:

    • DIAMONDS Search, whose aim is to find RNA signatures in blood from patients with infectious and/or inflammatory conditions.
    • 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.
    • Development and configuration of devices to rapidly detect gene transcripts required for PMSD and evaluation on improved patient diagnosis and treatment.
    • 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.
  • The Pandemic Respiratory Infection Emergency System Triage (PRIEST) Study

    The PRIEST 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.

    The project's specific objectives during the pandemic are:

    • to undertake continuous monitoring of the performance of the emergency care triage method (or methods) used for suspected respiratory infections during a pandemic
    • to identify clinical characteristics and routine tests associated with under-triage (false negative assessment) or over-triage (false positive assessment) during a pandemic
    • to determine the discriminant value of alternative triage methods for predicting severe illness in patients presenting with suspected respiratory infection during a pandemic
    • to inform policy makers and practitioners during a pandemic of the study's emerging findings.

    The project's specific objectives after the pandemic are:

    • to determine the discriminant value of emergency department triage methods for predicting severe illness in patients presenting with suspected pandemic respiratory infection
    • to determine the discriminant value of presenting clinical characteristics and routine tests for identifying severe illness
    • to determine the independent predictive value of presenting clinical characteristics and routine tests for severe illness
    • to develop new triage methods based upon presenting clinical characteristics alone or presenting clinical characteristics, electrocardiogram (ECG), chest X-ray and routine blood test results, depending upon the data available and the predictive value of variables evaluated in objective 3.
  • Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (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.

  • Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST) trial: An open label dose escalation phase 1 trial followed by a randomised, double-blind, placebo-controlled phase 2 trial.

    The REALIST trial is a trial of Mesenchymal Stromal Cells (MSCs) for acute respiratory failure.

  • Clinical Characterisation Protocol for Severe Emerging Infection (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 broadest acceptance.

  • Randomised Evaluation of COVID-19 Therapy (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.