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How we’re supporting COVID-19 convalescent plasma trials
NHS Blood and Transplant is investigating the effectiveness of treating coronavirus patients with plasma from people who have recovered from COVID-19. Heather Pinches, Head of the Clinical Trials Service at NHS Digital, explains how we’re helping with this effort.
30 June 2020
Around the world, researchers are racing to find an effective treatment for coronavirus (COVID-19). A range of potential treatments have been suggested, including convalescent plasma therapy.
Convalescent plasma is the liquid part of blood taken from people who have recovered from COVID-19, which may contain antibodies that prevent the coronavirus from entering and infecting cells in the body.
There’s evidence to suggest that transfusing COVID-19 patients with convalescent plasma could improve their recovery time and increase their chance of survival. NHS Blood and Transplant (NHSBT) are involved in two clinical trials – REMAP-CAP and RECOVERY – to establish if treatment with convalescent plasma does benefit patients and if so, at what point in their illness they should be treated.
A treatment ready to test
NHSBT already collects plasma from donors in the form of fresh frozen plasma (FFP), which is routinely given to patients after a major haemorrhage or trauma. Convalescent plasma is the same blood component as FFP and is manufactured to the same Medicines and Healthcare products Regulatory Agency (MHRA) regulations – the only difference is that the donor is known to have recovered from COVID-19.
Because doctors can already prescribe the use of any blood component NHSBT manufactures, convalescent plasma can be used by patients without additional research and development or ethics approval. However, it’s important that it’s used in the context of a clinical trial, otherwise it won’t be possible to determine if there are any benefits to COVID-19 patients compared to the normal course of treatment, and to identify which patients it will benefit the most.
So, there’s already infrastructure in place to collect and process convalescent plasma, it’s safe to transfuse, and there’s clinical trials set up to test this treatment. What’s needed now are the donors.
We had to carefully consider what was the right thing to do, knowing not everyone would want their data used in this way but also recognising the potentially enormous benefit this treatment could bring to COVID-19 patients.
How we're helping
Thousands of convalescent plasma donations are needed from people who have recovered from COVID-19 for the REMAP-CAP and RECOVERY clinical trials, and to establish a continuing supply for treatment.
NHSBT needs a larger pool of donors than those they currently have registered in their systems, so they asked for our help identifying people who fit the criteria to donate so they could contact them directly.
We had to carefully consider what was the right thing to do, knowing not everyone would want their data used in this way but also recognising the potentially enormous benefit this treatment could bring to COVID-19 patients. We worked closely with our Information Governance team and our Caldicott Guardian and decided to share the data with NHSBT, as we were allowed to do so under emergency legislation during the pandemic.
We send them updated data weekly and have identified over 112,000 potential donors so far.
We’re doing this by linking demographic data we hold with COVID-19 test data, hospital admissions and intensive care data to identify thousands of patients that have recovered from COVID-19 who may be suitable donors. We’re making sure to remove details of anyone who has opted-out of sharing their data and others who would not be able to donate, for example those who are shielding.
We’re sharing this linked dataset with NHSBT, who are using it to contact potential donors directly. We send them updated data weekly and have identified over 112,000 potential donors so far. As a result, 180 patients have been randomised in the convalescent plasma segments of the RECOVERY and REMAP-CAP clinical trials, and we are proud to be playing a small part in contributing towards finding an effective treatment for patients who are severely ill with COVID-19. Its been a great team effort to make this happen.
At NHS Digital we have recognised the value of routinely collected NHS data to support clinical trials such as these. We are working in partnership with the University of Oxford Big Data Institute, IBM and Microsoft to create the NHS DigiTrials health data research hub to develop a range of data services specifically for clinical trials.
How you can help too
If you have had a positive test result for COVID-19 or have had symptoms of COVID-19, you can help by registering to donate plasma. NHSBT particularly wants to hear from recovered people who are men, or who are aged over 35, or who needed hospital treatment.
NHS DigiTrials, the Health Data Research Hub for clinical trials, is part of a number of new services being developed to enable more efficient and effective clinical trials. It supports commitments made to life sciences following the publication of the L Life Sciences Sector Deal 2.