Clinical trial questions
The NHS Blood and Transplant Clinical Trials Unit is managing the convalescent plasma aspects of the REMAP-CAP and RECOVERY trials.
This page answers some of the common queries about the trials.
Why not start with the RECOVERY study as it's recruiting more quickly and open in more hospitals than REMAP-CAP?
REMAP-CAP is for patients in intensive care and who, therefore, are under the highest levels of observation and care.
This is one reason why – for clinical trial purposes – this provides increased opportunity to observe and also to intervene if necessary.
Can transfusion lab managers be informed if their hospitals sign up for the clinical trials, so they know to expect requests for this plasma?
NHSBT’s Clinical Trial Unit is responsible for setting hospital sites up to the trials.
This includes relevant training and other communication. Set up includes provision of barcodes for Laboratory Management Systems (LIMS) and to arrange for COVID-19 convalescent plasma to be visible/orderable by hospitals via the Online Blood Ordering System (OBOS).
Should there be a 'control' plasma arm (perhaps the low titre donations) in case of any anti-cytokine antibody/effect?
No, there should not be a control plasma arm.
Plasma transfusions are not part of routine practice for this disease and any intervention should be compared against standard practice.
Often trials use a placebo in this situation, but plasma is not inert and therefore cannot be classed as a placebo.
Will there be an opportunity to examine the anti-CoV-2 antibody response in convalescent plasma in detail?
In the REMAP-CAP trial we plan to collect successive blood samples in 400 patients where we will compare the effects of convalescent plasma (200 patients) on immune and cytokine responses compared to those who have not received convalescent plasma (200 patients).
These investigations are being led by researchers from the University of Oxford, King’s College London, and the University of Cambridge.
Both REMAP-CAP and RECOVERY have received all ethics and funding approvals and have been approved to proceed.
The NHS Blood and Transplant Clinical Trials Unit is setting up approved hospitals to receive convalescent plasma as part of the trials.
We want to collect plasma from donors with a sustained high level of antibody response to COVID-19 because we plan to collect plasma from donors on more than one occasion.
28 days from recovery also makes sure donors are well enough to donate.
This was decided on after reviewing previous studies that have shown positive effects after treating Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) (other coronavirus infections), and collaboration with other researchers around the world who are giving similar doses.
We are already doing RECOVERY and REMAP-CAP, do we need to apply separately for the convalescent plasma part?
You will need to let the central trial teams know that you want to take part in the convalescent plasma part of the trials and ensure that the major amendments that are required have been approved.
Are there any plans to collect plasma from people who get vaccinated against SARS-CoV-2 in the UK clinical trials?
There are currently no plans to collect from those who have been vaccinated.
Why is primary endpoint different for the convalescent plasma as opposed to the other areas of REMAP-CAP which is all cause 90-day mortality?
The primary endpoint is the same as the rest of the REMAP-CAP pandemic domains. 90-day mortality is the primary outcome for non-pandemic domains.
Re-infection is not an exclusion criterion, so they will be eligible.
For REMAP-CAP you can register through the trial website
Men and women can donate. Antibody levels will be checked in each donation, and donations from women that have high levels of anti-COVID-19 antibodies will undergo have extra screening to check for anti-HLA and anti-HNA antibodies. Donation that have these antibodies will not be used in the trials.
We are particularly interested in hearing from men, people over 35 and people who had to be hospitalised due to COVID-19 because they are more likely to have higher levels of antibodies.
People who receive convalescent plasma are permitted to donate convalescent plasma after their recovery. SaBTO (the Advisory Committee on the Safety of Blood, Tissues and Organs) has allowed this short change in donation rules.
No. Plasma is only being used within clinical trials at the moment.
The trials are collecting ethnicity data. This can be used to check that the population of patients included in the trial are representative of the general population who have had COVID-19.
We do not think that people will respond differently to convalescent plasma based on ethnicity, so there is no current plan to perform a specific analysis related to ethnicity within the trial.
There is currently a good stock of plasma available for issue to hospitals. However, if the plasma stock levels decrease, patients can still be enrolled into the REMAP-CAP or RECOVERY trials and receive other appropriate treatment(s).
How did you choose the COVID-19 patients that will receive the convalescent plasma in terms of severity of disease and age?
In REMAP-CAP patients are adults who are critically ill due to COVID-19 and require treatment in an intensive care environment.
In RECOVERY patients are children or adults who are moderately or severely ill due to COVID-19 and require treatment in a hospital.
Wherever possible patients should receive plasma from different donations.
We will send you an initial order of convalescent plasma before you are given the green light. Once you have issued a unit to a trial patient you can order convalescent plasma through OBOS as you normally would (drop-down menu) to replenish your stocks. Please do not order more than you use.
These can be documented in the plasma log.
No, the convalescent plasma should be stored separately to reduce chances of any mix-up (e.g. with FFP).
The storage requirements are exactly the same as fresh frozen plasma (FFP). The plasma should be stored at -25 and away from other blood products.
Thawing requirements are the same as FFP. The post-thaw ‘shelf-life’ has been extended for this product and is:
- transfuse within 4 hours if stored at room temperature (20-24 C)
- transfuse within 24 hours if stored between 2-6 C