Heartbeat: Critical care at the forefront of COVID-19 research

July 22, 2020

Critical care has been at the centre of the Trust’s research portfolio and currently has four studies which the team are actively recruiting to. They are also delivering treatments for patients who transfer from the wards who have been recruited to the RECOVERY study.

Two of the studies are complex treatment trials at the forefront of COVID-19 research.

REMAP-CAP is a complex treatment trial which is testing multiple treatment options simultaneously. This is known as a platform study. In REMAP-CAP, the treatments being tested are corticosteroids, antivirals, immune modulation therapy, immunoglobulin therapy (in the form of convalescent plasma) and therapeutic anticoagulation.

Within these therapy types there are several randomisation arms. Most research is intervention/drug a versus intervention/drug b, so this study is much more complex than usual.

Heartbeat caught up with Dr Jon Hulme, Consultant Intensivist and Honorary Senior Clinical Lecturer, who is the principal investigator on the REMAP-CAP trial. He told us: “The impact that COVID-19 has had on some of our patients has been clear to see. Large scale, robust trials to test which drugs help, and importantly, which ones do not, are hugely important for our patients and those we will treat in the future. Whilst there is the temptation that will be felt by many to use treatments and drugs based on what they think might work, it is only through committing to trials like these that the real answers will be uncovered that will save lives.

“Clinical trials are important as we have shown by participating in the RECOVERY trial: this found that dexamethasone, a steroid that is cheap and widely available and is commonly used to reduce inflammation in conditions such as asthma, saves lives in those people most affected by COVID-19. It reduces deaths by one third in people on a ventilator and by one fifth in patients receiving oxygen only.”

Dr Farooq Wandroo, Consultant Haematologist and Honorary Senior Lecturer is a co-principal investigator. He added: “One of the characteristic findings we have observed in COVID-19 patients is low white cell count called lymphopenia (low number of immune cells). This is universally seen in all COVID-19 patients, often leads to infections and is associated with increased risk of death. We are trialling a new drug called interleukin-7 which will aim at improving the number of these white cells or immune cells and help fight COVID-19 infection better and may reduce the risk of dying. We would urge all clinicians to help promote this important study.”

The newest study is a commercial trial looking at whether Recombinant Human Interleukin-7 can improve clinical outcomes in patients in critical care with severe COVID-19 infections and, in particular, lymphopaenia. You can read further about this trial on page four of this edition of Heartbeat.

These studies are complex and challenging to explain to patients, particularly patients that are so ill.

“One of the problems that we often experience in intensive care or emergency medicine research is that patients are so ill that we cannot discuss the studies with them. This current research is considered so important that sites have been given permission to enrol patients even in these situations with a senior doctor who is separate from the study team taking the responsibility to assess the situation and decide on the patients’ behalf until they regain capacity,” added Dr Hulme. “We are also ensuring that patients who have limited English can participate in studies. Sometimes a lack of ability to speak English is written as an exclusion criterion for the study, in which case we cannot approach non-English speaking patients.

“The participant information sheet for REMAP-CAP has been translated into multiple languages (although a limited number and not the full spectrum of languages spoken by our patients) alongside which patients still need the research explaining to them. The whole team of doctors, nurses, research team and interpreters have worked together with patients and their families to ensure that all of our patients have the opportunity to participate.”