CEM/CMO/2020/032
18
th
August 2020
Dear colleagues,
Thank you for your hard work in responding to COVID-19. As well as providing clinical care
for COVID-19 patients many of you have also supported research into COVID-19 in order to
improve care for patients in the future. Due to your efforts, and the generosity of patients in
volunteering, over 110,000 UK participants have now enrolled in COVID-19 urgent public
health research supported by the National Institute for Health Research (NIHR) and its
devolved nation equivalents. An example of the importance of research for patient care is
the finding from the RECOVERY trial that dexamethasone reduces deaths by one-third in
patients receiving invasive mechanical ventilation and by one-fifth in patients receiving
oxygen. This finding has informed clinical practice worldwide and was down to your efforts in
facilitating research in the NHS.
As COVID-19 patient numbers are now low it is more important than ever that those
remaining patients are always invited to join the urgent public health (UPH) studies. While
under the pressure of the peak some hospitals recruited 60% of eligible patients into the
RECOVERY trial. Now, with less workforce pressure, this kind of figure is what we should be
aiming for everywhere. It should be the default position that every eligible patient is offered
enrolment into a trial.
As well as increasing recruitment now we must also ensure that our research and trial
systems are strengthened and ready to increase recruitment if the number of COVID-19
cases increases. The national coverage and recruitment success of RECOVERY means it is
uniquely well placed to take forward the clinical evaluation of COVID-19 therapeutics.
RECOVERY will therefore continue to be supported as the national clinical trial platform for
COVID-19 phase III therapeutics trials and will also be extended to include phase II trials.
The expanded RECOVERY platform will form the principal vehicle for all publicly funded
phase II studies.
As part of a streamlined treatments prioritisation process, candidate therapeutics for phase II
trials will be identified by an independent and expert UK COVID-19 Therapeutic Advisory
Panel (UKCTAP). More information here https://www.gov.uk/government/publications/covid-
19-treatments-making-a-proposal-for-clinical-trials. The chief investigators of existing publicly
funded phase II trials have been asked to review their programmes and, if they wish, to
present their data to the UKCTAP for possible inclusion within RECOVERY. This is a
positive step forward and a move to a more holistic and nationally coordinated approach.
CEM/CMO/2020/032
If the previous phase II trials wish to continue then of course they can, although we
encourage them to transition their proposed treatments to RECOVERY, and for recruitment
to be focused here. The trial arms that were awarded UPH status (bemcentinib, MEDI3506,
acalabritinib, and zilucoplan in ACCORD; namilumab and infliximab in CATALYST;
baracitinib and ravulizumab in TACTIC; and TD139 and nafamostat in DEFINE) will retain
their status if they continue, but further arms to the studies will not be awarded UPH status.
The research response to COVID-19 is also moving into the next phase, which includes
preparation to support a number of large scale COVID-19 vaccine studies and driving
forward the studies looking at convalescent plasma. There is also an increasing need for
research that was paused due to COVID-19 to restart. Other impacts on health have not
gone away, and it is important that the research done in these areas is continued where
possible. With this in mind it is vital that research delivery staff and clinical academics return
from frontline and other duties and resume their research.
Research that identifies effective treatments and vaccines is critical for our return to pre-
COVID-19 normality. Thank you all for your efforts in making this research happen.
