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UK recruits first patient into Novartis global COVID-19 study

 

The first patient to join a global COVID-19 study being run by Novartis Pharmaceuticals was recruited on Saturday 2 May 2020 at Leeds Teaching Hospitals NHS Trust in the UK.

Recruiting a first global or first European patient is a key performance indicator for the life sciences industry as it demonstrates how the UK can support the rapid set-up and delivery of clinical research. The UK was the first of six participating countries to enroll a COVID-19 patient into the study, beating the USA, Spain, France, Italy and Germany.

In response to the COVID-19 crisis a single, collective system-wide approach has been established in the UK to prioritise and expedite research relating to COVID-19. It involves multiple organisations including: the National Institute for Health Research (NIHR); Public Health England; UK Research and Innovation; the Health Research Association (HRA); and the Medicines and Healthcare Products Regulatory Agency (MHRA), among others. This collaborative way of working has resulted in a number of nationally prioritised COVID-19 studies being initiated in record time.

As well as achieving the first global patient for one trial, UK performance has been exemplary in a second global Novartis study. Helen Townsend, Country Head - Trial Monitoring for Novartis Pharmaceutical UK and Ireland said:

“I have been so impressed with the teamwork across UK partners on our COVID-19 studies (Novartis, NIHR, hospital research sites, MHRA and HRA) – this has enabled us to get global first patient visit for the one study and to be the third country worldwide to start another. In addition, the UK was the first country worldwide to open all sites for both studies, showing that we can offer fast start up for multiple sites in parallel.”

Mark Toms, Chief Scientific Officer for Novartis Pharmaceutical UK and Ireland said:

“It is fantastic to see the UK life sciences ecosystem and Industry work together with speed, efficiency and quality at a time when we need to urgently find treatments for patients with this disease. In particular, the close collaboration between the NIHR Clinical Research Network and Novartis has been a real factor in getting these studies going so quickly.”

Sine Littlewood,  Director of Business Development and Marketing (Interim) for the NIHR Clinical Research Network said:

“The importance of initiating and delivering clinical research at pace has never been more evident than in the COVID-19 pandemic. As well as receiving great feedback from companies like Novartis, it’s fantastic to see the UK performing so well against countries like the USA, France and Germany. The UK’s collaborative culture has been a key enabler in our collective, system-wide response to the crisis which the NIHR is coordinating and delivering through our health research infrastructure embedded throughout our National Health Service (NHS). This experience will help us build on our position as a great country to support life-sciences research in the future.”
 
Dr Sinisa Savic and his team at Leeds Teaching Hospitals NHS Trust recruited the first patient said:

“Despite the fact that members of our COVID19 research team have come from various clinical backgrounds, we were quickly united by the desire to provide our patients with an opportunity to access potently beneficial treatments. The rapid set up and delivery of this trial was made possible by all team members coming together behind this common goal.”

Tanya Turgoose, Industry Operations Manager for Yorkshire and Humber Local Clinical Research Network said:

"First global patient is a great achievement under any circumstances, but is incredible in the current climate in which sites across the globe are racing to provide their patients with potential treatment opportunities for COVID-19. It reflects the huge collective effort across the Leeds Teaching Hospitals NHS Trust to provide the best possible patient care.”

The study (known as RUXCOVID)achieving the first global patient in the UK  is a phase 3 randomised, double-blind, placebo-controlled multi-centre study to assess the efficacy and safety of a protein kinase inhibitor drug (used to treat cancer) in patients with COVID-19 associated cytokine storm. Cytokine storm is a severe immune overreaction that can be triggered by a viral infection and can lead to serious complications, including pneumonia and acute respiratory distress. Patients with COVID-19 associated cytokine storm who experience these complications often require intensive care, including breathing support by mechanical ventilators. The second Novartis study referenced above (known as CANCOVID) is a phase 3 multi-centre, randomised, double-blind, placebo-controlled study to assess the efficacy and safety of a monoclonal antibody (used to treat auto-inflammatory conditions) on cytokine release syndrome in patients with COVID-19-induced pneumonia.

Both studies have been nationally prioritised as Urgent Public Health Research in the UK. Further information on how life science companies can apply for support to expedite and deliver commercial COVID-19 research in the UK is available on the NIHR website.