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.
The following studies are now open within the Trust
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.
ACTT: Adaptive COVID-19 Treatment Trial: A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalised Adults
There are no approved treatments, or vaccines, and hence there is an urgent need to assess the efficacy/safety of antivirals and other therapeutics to treat coronavirus (COVID-19). The Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (INSIGHT-10), is a double-blind placebo-controlled trial, of the anti-viral, remdesivir, for the coronavirus (COVID-19) treatment in hospitalised adults. This randomised control trial is testing whether a daily intravenous infusion of remdesivir (active drug) compared to N-saline placebo, provides clinical benefit, and is safe.
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.