Multi-million pound trial running at hospitals across the North East and North Cumbria will help rapidly find flu treatments this winter
A new national trial platform, launched today, aims to use pandemic lessons to help quickly find effective treatments for people hospitalised with severe flu.
There may be record numbers of flu cases this winter, and there is no clear evidence about how best to treat severe cases. Although many people with flu get better on their own without needing hospital treatment, it can make some people seriously ill and even be life threatening. Health officials and NHS leaders have warned 60,000 people could die this year from flu.
The £2.9 million REMAP-CAP trial will seek to recruit children and adults hospitalised with severe flu from 150 hospitals across the UK over the next two years, including in the North East and North Cumbria. It will be led by researchers and clinicians from Imperial College London and the Imperial College Healthcare NHS Trust in collaboration with other national experts and is funded by the National Institute for Health and Care Research (NIHR).
This is the first time a trial of this kind will be used for flu. The REMAP-CAP trial was originally set up to tackle pandemics. It is exactly two years since REMAP-CAP showed in COVID-19 how reducing inflammation with the drug tocilizumab can save lives in severely ill patients.
The trial is designed to provide answers quickly by using a robust yet rapid approach to test multiple treatments at the same time in thousands of people. The trial will be highly adaptive, allowing the team to learn quickly from early results and ensure people are given treatments that show encouraging results as soon as possible.
Professor Anthony Gordon, Chief Investigator of the new trial, from Imperial College London’s Department of Surgery and Cancer and Consultant in Intensive Care Medicine at Imperial College Healthcare NHS Trust, said: “During the pandemic, our trial was able to rapidly respond to a new virus and our approach helped save lives. We’re now redeploying it against a known threat. Flu is very infectious and can make children, the elderly and vulnerable people seriously unwell in some cases.”
“This winter, we might see more flu cases than usual as the virus potentially resurges after pandemic measures have kept levels low. We hope that our trial will help to find urgently needed flu treatments rapidly. Our COVID-19 trial changed clinical practice globally, and we hope we can impact flu treatment and reduce winter pressures on the NHS in the same way.”
Running for two years in the first instance, the trial aims to recruit several thousand people, and will test multiple treatments. These include the anti-viral treatments, oseltamivir (also known as Tamiflu) and baloxavir, as well as steroids and anti-inflammatory drugs that were found to be effective against COVID-19 in the original REMAP-CAP trial. More treatments may be added in the future.
The trial will be open to adults, children, and babies over the age of one month who are hospitalised with severe flu. Children and babies will receive lower treatment doses than adults.
Professor Caroline Wroe, Clinical Director of the NIHR Clinical Research Network North East and North Cumbria, said: “REMAP-CAP will run at over a hundred sites in the North East and North Cumbria. We are grateful to all staff who are working hard to deliver this key study and are proud to be part of this national effort to find new and better treatments for people who are hospitalised with flu.”
The researchers will study how effective the treatments are at reducing deaths from flu and stopping patients needing intensive care.
To help them to determine which treatments provide the best use of NHS resources, the researchers will also monitor whether the treatments reduce severe symptoms, stop people needing breathing support, and shorten the amount of time people stay in hospital or intensive care. The researchers will also measure quality of life and disability after recovery.
The trial brings together leading UK experts including specialists in intensive care, respiratory medicine, and children’s medicine. It will also involve experts in infectious diseases and virology who will carefully monitor to see if the flu virus becomes resistant to any of the anti-viral drugs tested in the trial.
Unlike other trials, which usually test individual treatments for a set amount of time, the new trial – known as an adaptive platform trial – continues as new treatments are added. Any treatments which are found not to work are removed. It will also involve trialling the treatments alone, in combination, and for different durations to find the best way to treat flu.
“Using this approach, we can bring in new treatments and test them thoroughly against one another without having to stop and start trials. Typically, you’d need a new trial for every treatment, which takes time. Instead, this type of trial keeps research rolling,” explained Professor Gordon.
Patient groups have helped design this trial platform through workshops and interviews.
Professor Andy Ustianowski, NIHR Joint National Infection Specialty Lead, said: "This landmark study aims at urgently providing new treatments for thousands of people at risk of becoming seriously ill or dying from flu. NIHR played a critical role funding, enabling and delivering trials in the fight against COVID and its heartening that we are building on the legacy of high quality research, by funding new adaptive research to tackle other deadly illnesses.
"The benefit of running a platform study like REMAP-CAP is that it is a more efficient way of delivering answers and evidence around new treatments. This could prove invaluable to help ease pressure on the NHS over winter."
