RECOVER, led by Professor Paul McNally, is a large, multi-center study which is taking place in eight paediatric and adult sites across Ireland and the UK over a three-year period. Funded by CF Ireland, the CF Foundation (US) and the CF Trust (UK), the study is examining in detail the impact of the new triple combination CFTR modulator compound, Kaftrio, on the lives and health of people with CF.
RECOVER is not a clinical trial as it is examining the effects of Kaftrio only after it has been prescribed for patients by their medical team. The project will gather both routine health data and less commonly used clinical endpoints such as lung clearance index, Chest CT, gastrointestinal symptoms, inflammation and medication adherence providing unique insights into the effects of the triple combination drug. The project is run in conjunction with the CF registry of Ireland and the UK CF registry.
The first 12 months of RECOVER has seen 116 adults and adolescents recruited across UK and Irish sites. Navigating COVID restrictions, the RECOVER team successfully conducted visits across all sites utilising a mix of virtual and in-person study visits. In January 2021, the study was recognised as a clinical trial in the UK sites. Through hard work and determination all sites are now activated and recruitment for Phase II of RECOVER is in full swing seeing children aged 6-11 recruited since November 2021.
In line with what was seen in clinical trials, the team have seen significant improvements in sweat chloride, lung function and nutrition in people with CF taking Kaftrio. The study has shown that, for participants with two copies of the F508del mutation, only 3% had a sweat chloride still in the abnormal range on Kaftrio, and more than 40% had a sweat chloride well within the normal range. They have also seen significant improvements in outcomes not used in trials, including LCI (a sensitive lung function test) and exhaled nitric oxide (a marker for airway inflammation). The data was presented at the North American CF Conference in 2021 and submitted to the European CF conference in 2022.
Three new sub-studies have been established as part of RECOVER – A psychology sub-study in collaboration with Trinity College Dublin examining experiences of young people (12-17) who have started taking Kaftrio®, a study examining the impact of Kaftrio on nasal and sinus disease in children with CF aged 6-11 in collaboration with RCSI and St James’s Hospital and finally a study with the University of Amsterdam using breath analysis to detect changes in airway metabolism and inflammation with Kaftrio treatment.
The achievements to date, outlined in the study milestones, could not have been met without the fantastic RECOVER participants, the PPI team, the collaborators and the research teams. For this, the RECOVER team would like to extend their sincere gratitude to everyone who has been involved up to this point and they look forward to continued success as we navigate through Year 2 for RECOVER and beyond.