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COVID-19 clinical research trials at the James Paget

01 May 2020

The front of the James Paget University Hospital - a two-story building with a pale grey exterior and lots of bay windows - with white patient transport ambulances parked outside 

The James Paget is leading the way being the only NHS Trust in the eastern region currently running a new clinical trial which seeks to find alternatives to in-demand ventilators in treating critically ill patients with COVID-19. The trial aims to reduce the need for treatment with a ventilator while improving patient outcomes.
The trial compares standard care for critically ill patients, which includes intubation and ventilation (considered medically invasive), with two non-invasive treatment methods. These are Continuous Positive Airway Pressure (CPAP) masks driven by oxygen or High-Flow Nasal Oxygen (HFNO) high-flow oxygen through the nose.
The UK is facing a shortage of both equipment and trained staff to operate ventilators, therefore it is crucial to find effective, alternative ways to treat patients with COVID-19. To deliver the trial, the Trust will receive additional CPAP and HFNO machines, avoiding the need to use existing equipment and increasing the team’s treatment capacity.
Those patients who choose to take part will be randomly allocated by computer to either receive standard care or one of the non-invasive treatments. Patients will receive all other treatments recommended by their clinical team. All three treatment arms are already commonly used in the NHS, but it is not yet known which is more effective in treating critically ill patients with COVID-19.
Dr Venkat Mahadevan, one of JPUH’s Consultants leading the RECOVERY-RS trial at the Trust, said, “The Respiratory & Critical Care teams at the JPUH have considerable experience with non-invasive ventilation treatments such as CPAP & high flow oxygen therapy in our patients. We know that these therapies can be highly effective in the right patient & in the right settings.
“Hence, I am delighted that we are able to offer these treatments, in a trial setting, for our critically ill patients with COVID-19. This trial will be a tremendous boost to find effective, alternative ways to treat patients with COVID-19, without the use of a conventional ventilator machine”.
Jamie-Louise Raven, JPUH Research Midwife, and Christian Hacon, JPUH Research Nurse, leading the study from a delivery perspective said,
“It is really important to offer trials to our participants and we are delighted to support staff and patients’ opportunities to participate in research”.
The RECOVERY Respiratory Support (RS) study is led nationally by the Warwick Clinical Trials Unit, part of Warwick Medical School at the University of Warwick, with support from the National Institute for Health Research (NIHR). JPUH is one of 6 sites across the country that are currently running the trial, however many more sites are expected to follow in the coming weeks.


Dr Helen Macdonald, who is Chief Operating Officer for the NIHR’s regional Clinical Research Network, said, “Well done to the team at JPUH, who have moved forward with great speed to bring this vital new research trial to their local community. Without research, and without those who take part in it, we simply can’t identify the ways to treat patients with this diagnosis, so we are extremely grateful to all those involved”.
This is a sister trial to the ongoing RECOVERY trial, using a similar infrastructure to enable the fast implementation of the new trial to find effective treatment for COVID-19 patients in Intensive Care Units.

The NIHR is funding and supporting a growing number of COVID-19 studies taking place in the NHS. These include those testing existing and new medications to treat patients with COVID-19 related symptoms. The results of all studies prioritised by the UK Government and the NIHR are essential to the future treatment of UK and global patients.