First adaptive clinical trial for flu
Posted: 29 November 2022 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
A £2.9 million trial, the first adaptive platform trial studying flu treatments, could reduce serious illness in patients.
A £2.9 million, UK-wide adaptive platform trial (APT) has been launched to find effective treatments for people hospitalised with severe flu for the first time, testing multiple options simultaneously in thousands of people then modifying treatments quickly. The research aims to find treatments that reduce deaths from flu and prevent patients needing intensive care.
The adaptive platform trial to study influenza
Originally set up to tackle pandemics, the new trial, titled Randomised, Embedded, Multifactorial, Adaptive Platform (REMAP)-CAP, will recruit children and adults hospitalised with severe flu from 150 hospitals across the UK over the next two years. The investigation will be conducted as an APT, which means it will continue as new treatments are added. Treatments that are found to be ineffective will be removed. It will also involve trialling the treatments alone, in combination, and for different durations.
This approach will allow the research team to analyse early results and modify their approach to ensure people are given successful treatments as soon as possible.
The initiative is delivered by the National Institute for Health and Care Research (NIHR)’s Clinical Research Network. It is funded by the NIHR and involves researchers and clinicians from Imperial College London and Imperial College Healthcare NHS Trust, in collaboration with other national experts with knowledge in intensive care, respiratory medicine, and children’s medicine. It will also involve experts in infectious diseases and virology who will monitor the flu virus to see if it becomes resistant to the anti-viral drugs tested in the trial.
Structure of the REMAP-CAP trial
Treatments planned to be assessed in the initial stage of the trial include the anti-virals oseltamivir (Tamiflu) and baloxavir, as well as steroids and anti-inflammatory drugs found to be effective against COVID-19 in the original REMAP-CAP trial. Additional treatments may be added as the study progresses.
To help establish what treatments use NHS resources in the most efficient way, the researchers will 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. Other parameters measured will be quality of life and disability after recovery.
Dr Elizabeth Whittaker, a Consultant in Paediatric Infectious Diseases at Imperial College Healthcare NHS Trust and a Senior Clinical Lecturer in the Department of Infectious Diseases at Imperial College London, is leading the children’s part of the trial. She stated: “Getting the free spray flu vaccine is our first line of defence and drastically reduces the risks for children. But we also need more treatments to help those children who do become very ill, which is why this trial is so important.”
Minister for Health and Secondary Care Will Quince commented: “This innovative trial will use the lessons we learned from Covid and deliver treatments to reduce serious illness in patients with influenza, ease pressure on the NHS and ultimately save lives.”