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Publish date: 21 October 2020
Blood plasma is a yellowish liquid that makes up about half your blood volume and contains antibodies that help fight infection.
The rationale behind the COVIPLEX trial led by UCLH consultant Dr Marie Scully is that in severe Covid-19 infection plasma exchange (PEX) therapy could help reduce the hyperinflammation, thrombosis (formation of blood clots) and lung damage seen in severe Covid-19. PEX therapy may also reduce damage to organs such as the heart, kidneys and brain.
In similar conditions that are also characterised by inflammation and thrombosis – such as a set of diseases called thrombotic microangiopathies – PEX therapy can help resolve the inflammation and thrombosis.
At UCLH the trial will be run by the Department of Haematology and Intensive Care Unit. It will include patients who have been hospitalised and are receiving respiratory support – for example via CPAP.
Up to 40 trial participants will receive either standard or care, or standard of care together with PEX therapy. Researchers will compare the reduction in inflammatory markers and compare rates of mechanical ventilation needed between the two groups, among other outcome measures.
PEX will be given for a minimum of 5 days, but the course can be repeated depending on a patient’s response. Patients will receive OctaplasLG solution for infusion, a UK licensed product made up of human plasma.
Dr Scully, who is UCLH clinical lead for haemostasis and thrombosis said: “We look forward to seeing whether PEX therapy can help in severe cases of Covid-19. There is good reason to believe it will be beneficial – based on the fact that it is effective in conditions with similar characteristics and on the results of our feasibility study. We need more treatment options as we enter a second wave of infections and we hope PEX therapy could help meet this urgent need.”
Professor Bryan Williams, Director of the Biomedical Research Centre at UCLH and Physician, said: “This is one of several early phase studies of novel therapies which are a key and exciting part of research initiated by UCLH into Covid-19. Successful delivery of these early phase trials is critically important for generating robust evidence about what treatments for Covid-19 might work.”
LifeArc is pleased to be supporting the 12-month COVIPLEX trial as part of the charity’s activities addressing the need for new therapies for COVID-19. LifeArc has separately made £10m available to 15 other trials looking at repurposing existing medicines or those in the late stage of development as this approach offers one of the fastest routes to develop new treatments that could tackle the virus and its impact.
The study is being done with the support of UCLH staff Dr Mari Thomas, Dr Nish Arulkumaran, Dr David Brealey, Prof Mervyn Singer, Dr Samuel Clarke, and all those in the apheresis, haematology and intensive care unit teams at UCLH.
