News

12th May 2020

The clinical trials Wales is taking part in to find treatments for coronavirus

Patients are being recruited across the whole spectrum of the illness, including those with symptoms who are well enough to be at home as well as people seriously ill in hospital.

Wales is currently taking part in 10 public health research studies in an urgent attempt to find treatments for coronavirus.

The studies, set up through Health and Care Research Wales, are looking into multiple treatments for patients, identifying risk factors and specific genes which make people more susceptible to the damaging effects of Covid-19.

Patients are being recruited across the whole spectrum of the condition, ranging from those with symptoms in the community to patients in intensive care units who are seriously ill.

Studies are also focusing on the most effective treatments for specific groups of people, including pregnant women and children whose immune systems are not functioning as they should and affecting their ability to fight the virus.

We’ve taken a closer look at the each of these pioneering new studies.

1. Randomised Evaluation of Covid-19 Therapy (Recovery) trial

Open to every health board in Wales, the Recovery trial has been described as “the fastest-growing clinical trial in medical history”.

It is testing to see if new or existing drugs can help patients who have been admitted to hospital with confirmed Covid-19.

Led by the University of Oxford and funded by the Medical Research Council, it is currently the world’s largest randomised clinical trial of potential coronavirus treatments.

The first two therapies to be tested are a HIV drug known as iopinavir-ritonavir and low-dose corticosteroids, a class of drug that lowers inflammation in the body.

They will be evaluated to see if they are safe and effective when added to the usual standard of care.

Dr Daniel Menzies, who works at Ysbyty Glan Clwyd (Image: ITV Wales News)

Ysbyty Gwynedd, Ysbyty Glan Clwyd, and Wrexham Maelor Hospital are among 165 hospitals across the UK taking part.

Dr Daniel Menzies, who leads the Ysbyty Glan Clwyd team, told ITV Wales News: “Any patient who is unwell enough to unfortunately be admitted to hospital with coronavirus is eligible to take part.

“Patients are often willing to take part in clinical trials and this is no different. It’s only by conducting research like this that we can know for certain which drugs will work and which will not.”

He said there are suggestions from some preliminary work that anti-retroviral drugs used in HIV treatment may have some efficacy in treating coronavirus.

“But we don’t know that for certain yet, hence the reason for a trial to test exactly that,” he added.

2. Remap-Cap: a platform trial for severely ill patients with Covid-19

Health boards in Wales are also taking part in Remap-Cap, a trial for severely ill patients with Covid-19.

The international trial was specifically designed for a pandemic period.

Led in the UK by Imperial College London and funded by the University Medical Centre Utrecht, it is testing multiple treatments at the same time for patients admitted to intensive care with severe community-acquired pneumonia.

The multiple treatments will include antivirals, immune modulation drugs and corticosteroids – and more treatments will be added as new evidence emerges.

It is currently open to patients in Aneurin Bevan, Cardiff and Vale, Betsi Cadwaladr, and Swansea Bay University Health Boards.

3. Pandemic Respiratory Infection Emergency System Triage (Priest) study

When people first attend hospital emergency departments they are “triaged” by a clinician.

The process helps to identify which patients are in need of admission and urgent treatment.

During a flu pandemic, when hospital resources are likely to be stretched, medics say it is essential that these methods are as accurate as possible.

The Priest study aims to use patient data from the early phases of the pandemic to test the accuracy of existing triage methods and develop new and potentially more accurate methods. They can then be applied in subsequent phases of the pandemic.

This study is currently only open in the Aneurin Bevan University Health Board area.

4. UK Obstetric Surveillance System (UKOSS)

This UK-wide study, open to all Welsh health boards, involves women taken to hospital with confirmed Covid-19 in pregnancy.

Funded by the National Institute for Health Research (NIHR), the study 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.

The information will be analysed to inform ongoing guidance for women and maternity staff as Wales and the rest of the UK responds to the pandemic.

(Image: David Jones/PA Wire)

Specifically the study will look at 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 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.

5. Evaluation and refinement of pandemic influenza community assessment tools (Flu-Cats)

The University of Liverpool-sponsored study aims to help GPs, as well as other clinicians in primary care, make decisions about whether or not to refer patients to hospital in the event of a “surge” during an influenza pandemic.

It involves “real-time refinement and validation” of criteria and tools used in general practice.

It is open in Aneurin Bevan, Betsi Cadwaladr, Cwm Taf Morgannwg, Hywel Dda, Powys Teaching and Swansea Bay health boards.

6. Genetics of susceptibility and mortality in critical care (GenOMICC)

Our genes determine how susceptible we are to life-threatening infection.

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 susceptible to specific infections and consequences of severe injury.

The study is open in Cwm Taf Morgannwg and Swansea Bay University Health Board areas.

7. Recovery: Respiratory Support

Covid-19 can cause serious breathing difficulties and in many cases ventilatory (lung or respiratory system) support is needed to help the patient.

Deciding which form of ventilatory support is the most effective is critical to ensuring the best outcomes.

The Recovery trial will look at three different approaches to providing ventilatory support to patients suspected or confirmed Covid-19, all of which are currently in use in clinical practice.

These are high-flow nasal oxygen (HFNO), continuous positive airway pressure (CPAP), and standard care involving regular oxygen therapy.

A nurse attends to a Covid-19 patient that is wearing a CPAP helmet (Image: Marco Di Lauro/Getty Images)

The study aims to assess which method is most effective in relation to survival of patients and intubation (where a tube is inserted into a patient’s throat to help them breathe).

There is currently little evidence to support the use of HFNO or CPAP compared to standard care in patients with Covid-19.

So the new trial will also look at other important outcomes in patients while they are in hospital such as how long it takes to intubate a patient, time to death, survival in critical care, and length of hospital stay.

The randomised trial is taking place in 40 hospital sites in the UK with the aim to recruit 4,002 patients. It will take place over a period of 18 months.

Aneurin Bevan and Cwm Taf Morgannwg University Health Boards are taking part.

8. Neonatal Complications of Coronavirus Disease (Covid-19) Study

So far researchers have very little information about how the virus affects mothers and newborn babies and it remains unclear how best to care for them.

We have very little information about how babies get coronavirus, whether it transmits from mothers to their babies while they are still pregnant, during labour and birth, or whether the infection occurs following birth.

This study will collect information about newborn babies who have coronavirus or who are born to mothers who have coronavirus.

The information collected will help us to understand:

  • how babies get Coronavirus
  • what happens to babies when their mother has coronavirus
  • what treatments are effective in helping babies with coronavirus to get better
  • what happens to babies when they have been treated

The study is being carried out through a system called the British Paediatric Surveillance Unit (BPSU).

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 coronavirus or whose mother has coronavirus.

If they have they will be sent a questionnaire to collect information about the baby and their mother.

9. Pregnancy and Neonatal Outcomes in Covid-19

This study aims to better understand some specific research questions as to how Covid-19 affects early pregnancy, foetal growth, prematurity. and virus transmission to the baby.

The researchers will construct a registry of women with suspected and confirmed Covid-19.

10. Platform Randomised trial of INterventions against Covid-19 In older people (Principle)

Health and Care Research Wales is also working with the University of Oxford, and GPs across Wales, to set up the Principle study.

The trial aims to give a rapid answer about the effectiveness of different treatments – initially of hydroxychloroquine, an anti-malarial drug – in changing the development of the disease.

What do the experts say?

Professor Kieran Walshe, director of Health and Care Research Wales, said: “We’re facing an unprecedented challenge as we try to tackle the spread of Covid-19.

“It’s important we’re able to use our research capabilities and expertise to gather timely evidence that can lead to the most effective treatments and care and ultimately a vaccine.

“Health and Care Research Wales is prioritising resources and fast-track support for Covid-19 urgent public health research studies and is also working with UK counterparts to enable Welsh researchers to access funding for Covid-19 research.

“We are encouraging Welsh institutions and researchers to respond to the urgent research needs associated with the pandemic and its impact.

“I believe the research community in Wales can continue to make a difference and play a full part in finding a solution to Covid-19.”

The Dragon’s Heart Hospital at The Principality Stadium

Jayne Goodwin, national head of research delivery at Health and Care Research Wales, is overseeing the set-up and delivery of Covid-19 research studies at the Dragon’s Heart Hospital in the Principality Stadium in Cardiff.

Jayne, who is a research nurse, said: “Clinical research staff are highly trained but small in number within the NHS workforce. They are crucial to delivering research studies at the front line of care.

“Setting up research within Ysbyty Calon y Ddraig has provided a new challenge but it is fundamental that patients in all our facilities across Wales have opportunities to take part in research, receive treatments, and make a difference to future care and treatment of Covid-19.”