The RECOVERY trial, which discovered four effective treatments for COVID-19, has expanded to investigate treatments for influenza.
Globally, seasonal flu epidemics are estimated to kill between 290,000 and 650,000 people every year. Despite having known about influenza for almost a century and knowing that pandemic influenza remains one of the greatest threats to human health, we still do not have effective drugs for treating people with severe influenza.
Until now, few large-scale clinical trials have evaluated treatments for patients hospitalised with influenza. However, the features of the RECOVERY trial that made it such a success against COVID-19 – including its streamlined design, large scale, and practical integration into routine healthcare – make it well-placed to also improve the care of severe influenza patients.
The RECOVERY Trial was supported by the NIHR Oxford Biomedical Research Centre (BRC), and, as well as being widely praised, it was considered an ideal model for similar large-scale clinical trials for a range of conditions.
Using the RECOVERY Trial model – in terms of design, methodology, delivery and evaluation techniques – BRC researchers are building the infrastructure to support other trials based on routinely-collected data.
Sir Peter Horby, Joint Chief Investigator for the RECOVERY trial, said: “As well as being the greatest pandemic risk, influenza remains a serious annual scourge. In a bad year, as many as 25,000 people in the UK die as a result of influenza.
“Yet we have no treatments that have been proven to improve outcomes in hospitalised patients. By including influenza in the RECOVERY trial, we have the opportunity to change this and find new treatments for this persistent menace.”
As well as in the UK, the study will be open to patients hospitalised with confirmed influenza in selected hospital sites in France, Italy and the Netherlands through a new partnership between the University of Oxford and Ecraid (the European Clinical Research Alliance on Infectious Diseases). It will also be open to patients in hospitals that have previously participated in RECOVERY in Asia (India, Indonesia, Nepal and Vietnam) and Africa (Ghana and South Africa).
Participants will be randomly allocated to receive either the usual standard of care or the usual standard of care plus at least one of the treatments in the trial. RECOVERY will investigate the following drugs initially:
- Oseltamivir, an antiviral medicine (known as Tamiflu) that has been shown to provide benefit in mild influenza
- Baloxavir marboxil, an antiviral medicine (known as Xofluza) that has been licensed to treat uncomplicated, mild influenza
- Low dose corticosteroids that have been shown to benefit some patients hospitalised with COVID-19.
Sir Martin Landray, Professor of Medicine and Epidemiology at Oxford Population Health and Joint Chief Investigator for RECOVERY, said “RECOVERY was designed to provide a robust test of possible treatments for COVID-19 whilst keeping the burden on hospital staff and the health system to a minimum. This approach led to the discovery of effective treatments for COVID-19, such as dexamethasone, which have now saved hundreds of thousands of lives around the world. We are now expanding this approach to tackle the long-term challenge of influenza.”
The 2022–2023 influenza season marked the return of influenza virus activity at almost pre-pandemic levels in the EU/EEA countries, highlighting an urgent need for assessment of flu treatments.
RECOVERY’s assessment of treatments for flu is funded by Flu Lab, based in the United States. Through grants and investments, Flu Lab supports efforts to advance innovative solutions to persistent problems in the prevention and treatment of influenza.