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Prioritisation of COVID-19 research

Working with partners across UK, Scotland is leading, enabling and delivering world-class COVID-19 research, a key element of the Government’s overall response to the pandemic.

Given the extraordinary pressures currently being faced by the health and care system, we must ensure the best use of limited resources and capacity available to support research. 

As such, Scotland forms part of a single national UK process led by NIHR and draws on expert advice to prioritise the COVID-19 studies which hold the most potential for tackling the challenges faced. 

This process will cover funded studies, irrespective of whether they are funded by the public sector, industry or charities and also, in partnership with UKRI, studies that require funding. All NHS trusts/boards, health and care providers and universities will need to prioritise support for studies which have been nationally prioritised. 

With regard to HRA approvals, researchers should make an application through the national prioritisation process first and will be signposted for expedited regulatory approvals so that approval review can progress in parallel to the system of assessment leading to a view on prioritisation.  

Rapid Research in COVID-19 programme

The Chief Scientist Office of Scottish Government launched a call for COVID-19 research proposals on 25 March. One hundred and thirty-nine proposals were received from across Scotland’s universities and research institutes. Following an independent expert review process, 55 projects have been selected for funding, establishing a pan-Scotland portfolio of high-quality research on COVID-19 that will be delivered rapidly and inform policy and clinical practice in responding to the pandemic.

RARC-19 programme

£5 million of funding from the Scottish Government's Chief Scientist Office (CSO) for research projects to increase the understanding of (COVID-19), screen potential treatments and support clinical trials.

The funding will support 55 rapid research projects in 15 Scottish universities and research institutions, contributing to global efforts to combat the virus and its wider effects, including research to: 

  • better understand the effects of infection
  • develop and test new diagnostics and treatments 
  • investigate new disease surveillance approaches
  • inform interventions to prevent transmission of infection
  • support the mental health of frontline health and social care workers
  • understand the physical and mental health implications of lockdown measures

The CSO website lists a full breakdown of the research institutions, projects and individual funding for each of the projects.

 

Current research

Clinical trials are currently taking place across primary care, hospital settings and ICU’s. The following Coronavirus (COVID-19) related research studies are active in Scotland:

ISARIC: Understanding behaviour and spread of COVID-19 in the UK

Part of £10.5 million funding award by NIHR and UK Research and Innovation (UKRI) to support six new research projects on developing and testing vaccines and therapies for the novel coronavirus (COVID-19).

Dr Kenneth Baillie, University of Edinburgh; Professor Peter Openshaw, Imperial College London; and Professor Calum Semple, University of Liverpool - £4.9m

The team will collect samples and data from COVID-19 patients in the UK to answer many urgent questions about the virus in real-time, such as:

  • who in the population is at higher risk of severe illness
  • what is the best way to diagnose the disease
  • what is happening in their immune systems to help or harm patients
  • how drugs behave in people with the infection
  • how long people are infectious for and from which bodily fluids
  • whether people are infected with other viruses (e.g. flu) at the same time

The study will recruit at least 1,300 UK patients over the next year and aim to start communicating their initial results in months.

The team’s capacity builds on planning over the past 8 years as part of the International Severe Acute Respiratory Infection Consortium, and it includes co-investigators from six UK universities and Public Health England.

RECOVERY: Re-purposing existing and new drugs for COVID-19 patients

Part of £10.5 million funding award by NIHR and UK Research and Innovation (UKRI) to support six new research projects on developing and testing vaccines and therapies for the novel coronavirus (COVID-19).

Scottish Government is also providing £3.3 million to fund governance and support funding for this trial.  

Professor Peter Horby, University of Oxford - £2.1m

The Randomised Evaluation of COVID Therapy (RECOVERY) trial will test if existing or new drugs can help patients hospitalised with confirmed COVID-19.

The first two therapies to be tested will be iopinavir-ritonavir (an HIV drug) and low-dose corticosteroids, which will be evaluated to see if they are safe and effective when added to the usual standard of care.

The trial will have an ‘adaptive’ design, meaning it can test new therapies as they become available. The team’s aim is to have data available to inform patient treatment within three months.

Read more: 

COVID BreathSpec: Identifying biomarkers in breath that characterise COVID-19

Analysis of volatile organic compounds (VOCs) in exhaled breath is of increasing interest in the diagnosis of lung infection. Patterns of VOC detected can offer information on chronic obstructive pulmonary disease, asthma, lung cancer and interstitial lung disease.

Compared with other methods of breath analysis, ion mobility spectrometry (IMS) offers a tenfold higher detection rate of VOCs. By coupling an ion mobility spectrometer with a GC column, GC-IMS offers immediate twofold separation of VOCs with visualisation in a three-dimensional chromatogram. The total analysis time is about 300 seconds and the equipment has been miniaturised to allow bedside analysis.

The primary objective of the COVID BreathSpec trial is to perform a GC-IMS metabolomic definition study in patients with clinical features consistent with pneumonia or chest infection to identify a signature of COVID-19 pneumonia in patients exposed to SARS-CoV-2, compared to unexposed patients or those without pneumonia. This would allow for the identification of biomarkers in the breath that characterises COVID-19.

PRIEST: Evaluating triage methods to determine outcomes in COVID-19 patients

The PRIEST study will evaluate current triage methods used to determine if a patient with suspected COVID-19 is to be admitted to hospital or not and whether or not they should be admitted to ICU/HDU. Based on the information collected from this study, two new triage tools are expected to be created:

  • the first will include clinical characteristics alone, and will be used in the community setting to determine if a full hospital assessment is required
  • the second would be used in emergency departments to determine if hospital admission is required and will include presenting clinical characteristics and investigations (ECG , chest X-ray and blood results)

These new triage tools will be evaluated based upon ability to predict adverse outcomes, patient death or requirement for cardiac, renal or respiratory support.

CERA: The impact of COVID-19 on emergency care settings

The CERA study aims to understand the evolving and cumulative effects of working during the COVID-19 outbreak on the psychological health of those physicians working in emergency care settings across the UK.

Physicians will be asked to complete questionnaires on their phones at 3 different time scales:

  • during the Acceleration phase (beginning)
  • during the Peak phase (middle)
  • during the Deceleration phase (end)

It is anticipated that this study will enhance future pandemic preparedness, by highlighting staff resilience and tolerance, and where further support – delivered either during or after an incident – may be beneficial.

The study itself is a TERN project with the support of EMERGE.

GenOMICC: Finding the genes that cause susceptibility to COVID-19

Susceptibility to COVID-19 is almost certainly, in part, genetic. The GenOMICC (Genetics Of Mortality In Critical Care) study aims to find the genes that cause susceptibility, which may help us to prioritise treatments to respond to the global crisis.

Since 2016, the open, global GenOMICC collaboration has been recruit patients with emerging infections, including COVID-19. All critically-ill patients with confirmed COVID-19 are eligible for GenOMICC.

UKOSS: Informing guidance around COVID-19 outcomes during pregnancy

The study, funded by the NIHR, will use the UK Obstetric Surveillance System (UKOSS) to collect anonymous information about all pregnant women admitted to hospital who are confirmed to have COVID-19. This will be analysed on a continuous basis to inform ongoing guidance for women and maternity staff in response to the pandemic.

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 UKOSS reporters, who are based in all maternity units in the UK.

UKOSS is led by Professor Marian Knight, from the National Perinatal Epidemiology Unit, University of Oxford.

REMAP-CAP: Reducing mortality, ICU use, morbidity in patients with COVID-19

REMAP-CAP (Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia) is an international platform trial that has been specifically designed for a pandemic period. The aim is 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 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.

The trial is funded by the European Commission and is led in the UK by Professor Anthony Gordon, Imperial College London.

FLU-CATs: Refining the criteria and tools in primary care to aid hospital referral decisions

FLU-CATs : Evaluation and refinement of pandemic influenza community assessment tools is designed to assess, refine and validate of triage tools to guide GP referral of patients with influenza-like illness during a pandemic in readiness for use should widespread illness exceed health care capacity (surge).

GPs participating in the Clinical Practice Research Datalink (CPRD) will record their assessment and management of patients with influenza-like illness. The study will explore linking CPRD to the supra-regional microbiology network database to provide linked-anonymised results on microbiological investigations for respiratory pathogens.

Weekly cumulative analyses are planned using CPRD data. Three monthly analyses are planned using linked HES data as a gold standard. Univariate and multivariate analyses using unconditional logistic regression will be used to investigate the association between:

  • triage criteria threshold values and primary outcomes (hospital admission, and death)
  • secondary outcomes (length of stay and augmented levels of care (high dependency / intensive care))

The trial is led by Prof Malcolm Semple, University of Liverpool and funded by the NIHR.

COVACTA: Safety and efficacy of Tocilizumab in patients with severe COVID-19

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

This study is funded by F. Hoffmann-La Roche Ltd.

STOP-COVID19: Exploring treatment for lung inflammation in COVID-19 patients

The STOP-COVID19 (Superiority Trial of Protease inhibition in COVID-19) trial will explore whether the drug brensocatib (formerly known as INS1007) can reduce the incidence of acute lung injury and prevent mechanical ventilation. It is hoped that the treatment will also lead to patients spending fewer days dependent on oxygen and shorter periods of time in hospital, reducing the burden on healthcare systems.

Trials conducted to date have shown that brensocatib reduces inflammation in the lungs of people with underlying lung conditions and it is hoped that it will have a similarly beneficial effect in those suffering from COVID-19.

The study is being led by Prof James Chalmers, British Lung Foundation Professor of Respiratory Research at the University of Dundee and Consultant Respiratory Physician at Ninewells Hospital, NHS Tayside.

Coronavirus infection in immunosuppressed children

This 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 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
  • 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 COVID-19 cases admitted to all NHS Trusts, including all children.

The study is led by Dr Hans De Graaf, University Hospital Southampton NHS Foundation Trust and funded by the British Paediatric Allergy, Immunity and Infection Group.

Evaluating safety & antiviral activity of Remdesivir for patients with moderate-severe COVID-19

The primary objective of these studies are to:

These studies are funded by Gilead Sciences Inc.