Case study: Seeking effective alternatives to mechanical ventilation for COVID-19 patients - the RECOVERY-Respiratory Support Trial
Read more about the RECOVERY-Respiratory Support study on the Warwick Clinical Trials Unit website.Find out more
Patients with severe symptoms of COVID-19 who may be struggling to breathe may require help to get more oxygen into their lungs. Currently patients may be treated with a ventilator in intensive care units or with a less invasive method of respiratory support.
By identifying which non-invasive treatments are most effective, and using these at an earlier stage, it may be possible to reduce the need for invasive mechanical ventilation, and therefore keep more patients out of critical care wards.
Three methods of non-invasive treatment are already being used in the NHS to treat patients with COVID-19. However, it is not known which is the most effective in the long term. In fact, recommendations for non-invasive treatments for COVID-19 patients across the globe are inconsistent.
As more patients were treated during the pandemic, some clinicians found non-invasive treatments helpful whilst others were concerned it delayed intubation, potentially causing harm. The existing evidence was not robust enough to reliably confirm which treatment had the greatest benefit and least risk to patients. Only with high-quality data from a randomised control trial will researchers be able to demonstrate which treatment truly has the best outcomes for patients and inform clinical practice going forward.
It is for this reason that the RECOVERY-RS trial (Randomised Evaluation of COVID-19 Therapy - Respiratory Support) was set up.
The trial is funded and supported by the NIHR, and is one of a number of COVID-19 studies that are considered to be urgent public health research by the UK’s Chief Medical Officers. It has been given priority status by the Department of Health and Social Care through the NIHR’s national prioritisation process. It has been strongly supported by the NIHR’s Clinical Research Network (CRN) including the West Midlands CRN Study Support Service, and national speciality groups for respiratory disorders and critical care.
The research compares three existing non-invasive treatments to determine which provides the best long-term outcome for patients. These treatments are:
- Continuous Positive Airway Pressure (CPAP) - where a patient wears a tightly fitted face mask through which a mild to high air pressure is applied on a continuous basis to keeps the airways open;
- High Nasal Flow Oxygen (HFNO) - where a patient receives humidified (moistened) and warmed oxygen through tubes into the nose;
- oxygen therapy - where a patient wears a normal face mask or tubes in the nose to receive oxygen.
Determining which treatment is most effective will take a number of factors into account. These include: the survival rate of patients receiving each treatment, the need for intubation (where a tube is inserted into a patient's throat to help them breathe), how long it takes to intubate a patient and the length of stay in hospital (both in critical care and other wards). Data will be collated over a 30 day period, or until the patient leaves hospital (whichever comes later).
Aware of the pressures on hospitals and NHS teams, the research has been designed to create minimal burden on sites that take part. The trial is flexible as not all the treatments must be delivered at every site, patients may be recruited from any part of the hospital, data collection has been minimised, and it is also possible to co-enrol with other COVID-19 studies.
The trial is ongoing and seeking to enroll more sites and more patients. Already set up in 72 hospitals (correct as of 9 September 2020) the study is hoping to be open in locations covering the length and breadth of the UK, so that wherever there are patients with COVID-19, there is an opportunity for them to take part in the study.
Delivering the RECOVERY-RS trial: the research teams' perspectives
The study is led by passionate researchers who urgently want to find answers for patients.
Professor Danny McAuley, Co-Chief Investigator, based at Queen’s University Belfast said:
“The unfolding COVID-19 pandemic brings an urgent need for new therapies, particularly for critically ill COVID-19 patients. We simply do not know what treatments are effective for this new disease and we urgently need this trial to test what is the best way to deliver respiratory support as an alternative to ventilators.”
Professor Gavin Perkins, Co-Chief Investigator, based at the University of Warwick Clinical Trials Unit added:
“Clinical trials are the only way to safely study these interventions and to offer patients the additional protections necessary within the carefully controlled environment of a clinical trial, and are the best way to quickly find effective supportive interventions for this global pandemic.”
Dr Jay Naisbitt, a Consultant in Intensive Care medicine, is a Principal Investigator on RECOVERY-RS. He found that integrating research into routine practice has facilitated patient recruitment into urgent public health studies and has boosted morale across his team. Read Jay's blog.
Heather Willis, a Research Nurse at Good Hope Hospital, has been working on the frontline, delivering urgent public health research, during the pandemic. Her experience working on the RECOVERY-RS trial has reinforced her views that research makes a real difference to patient lives and is best delivered as part of a team. Read Heather's blog.
Taking part in the trial: a patient's perspective
Phil Cawkwell, 38, was hospitalised with COVID-19 in early April 2020. Struggling to breathe, he was grateful to have the chance to take part in the RECOVERY-RS trial and hoped he’d be able to help other people as a result. While recovering at home but still feeling the effects of the virus, he told us his story.
“I am incredibly grateful I was offered the chance to take part in the trial. It’s a fantastic opportunity and gives you hope at a dark time to think you might be helping other people. I have always been interested in research and I would say to anyone who gets the chance - just do it.”