Chelsea and Westminster Hospital NHS Foundation Trust’s PIONEER trial published in The Lancet

The findings of the international PIONEER study, led by Chelsea and Westminster Hospital NHS Foundation Trust and supported by its official charity, CW+, and NEAT ID, and funded by LifeArc, has been published in The Lancet Respiratory Medicine—the world-leading respiratory medicine and critical care journal.

Titled Favipiravir in patients hospitalised with COVID-19 (PIONEER Trial): a randomised controlled trial of early intervention versus standard care, the article reveals the findings of the multi-national COVID-19 treatment study, which trialled the antiviral favipiravir for the treatment of mild to moderate COVID-19.

The study, the largest of its type involving favipiravir, started in 2020 and compared two treatments for mild to moderate COVID-19 inpatients. It recruited 502 patients across Europe and South America. The study concluded that across the age spectrum of all cases there was not a significant improvement in early clinical recovery or a reduction in mortality. However detailed post-hoc breakdown of the data indicated a slightly faster rate of recovery in patients under 60 years of age who received favipiravir. Conversely, in those over 60 years of age, the medication was not shown to be efficacious. Mortality, across all ages, was reduced slightly in the treatment group, but this was not statistically significant. The study was performed in the UK at the Chelsea and Westminster hospital, Royal Brompton and Harefield hospitals, Imperial College and Hull hospital, and in Latin America by units in Brazil and Mexico.

Favipiravir, an antiviral drug, has been licenced in Japan since 2014 to treat influenza. It works by inhibiting a viral enzyme called RNA polymerase, preventing viral replication within human cells. This viral enzyme is common to several viruses, including SARS-CoV-2, which causes COVID-19.

Professor Pallav Shah, the global chief investigator and principal investigator for the UK arm of the trial at Chelsea and Westminster Hospital NHS Foundation Trust, said: ‘I am delighted that this research has been published in The Lancet Respiratory Medicine journal, recognising that it was conducted in difficult circumstances at the start of the pandemic, across four countries. The merits of methodical research before widespread implementation of treatments is clearly demonstrated. Favipiravir is extensively used in several countries, but our work questions whether it has any effect at the current dose in the treatment of coronavirus infection, and especially in people over the age of 60 years.’

Chris Chaney, Chief Executive of CW+, said: ‘We are delighted that the PIONEER clinical trial has been published in The Lancet Respiratory Medicine journal. This has been an international effort and we would like to congratulate our clinical teams as well as all our partners who have worked across two continents on this all-important study. We would like to say a special thank you to all our donors for their incredibly generous support.’

Philanthropic funding has been instrumental in establishing the PIONEER study, with generous support coming from CW+, along with medical charity LifeArc, XTX Markets, Ageas and a broad community of individual donors.

Dr Melanie Lee, Chief Executive of LifeArc, added: ‘At the start of the pandemic we provided over £10 million to support trials testing whether existing drugs, or those in the late development stages, could also treat COVID-19. Existing drugs offered a faster route to treating COVID-19 patients at a critical time. We are excited to learn that favipiravir can potentially help patients under 60 to recover from mild to moderate COVID-19, faster. It’s equally important to know that it doesn’t work in people over 60, so they won’t receive this drug unnecessarily.’

You can read the article on The Lancet Respiratory Medicine website.

About the study

Fujifilm Toyama Chemicals provided its medication, favipiravir, to be used in the trial, as well as the relevant safety and other information required to obtain the official approvals necessary to start the trial. Neither they nor any charitable donor were involved in the design, methodology or conduct of the trial, nor have they had any involvement in announcement of the results.