NIHR Leeds BRC and CRF Response to COVID-19

Monday 22nd March 2021

The Leeds partnership, of the Leeds Teaching Hospitals and the University of Leeds includes the Leeds Biomedical Research Centre (BRC) and the Leeds Clinical Research Facility (CRF), alongside the wider research infrastructure.  The response of the Leeds partnership to Covid-19 has been exemplary, particularly in the area of early clinical trials and translational research.

Highlights

By coming together as a unified system, Leeds has demonstrated the capacity to respond quickly and agilely to the Covid-19 pandemic in trial set-up, prioritisation and recruitment.  

The first patient to enter a global COVID-19 study sponsored by Novartis Pharmaceuticals was recruited on Saturday 2 May 2020 at Leeds Teaching Hospitals NHS Trust in the UK.

In addition:

  • We recruited our first patient into Covid-19 nationally prioritised research study within five days; the first Covid-19 patient was admitted to Leeds Teaching Hospitals Trust on March15th 2020, with our first patient recruited into Covid-19 Research on March 20th.
  • Our Covid-19 delivery team, which included BRC and CRF staff, was formed within two days of the first Covid-19 patient being admitted, co-ordinated by the Leeds Teaching Hospitals Trust R&I department and supported by CRF and BRC teams
  • We have consistently opened studies quickly; the average time from Leeds being selected as a study site to study opening has been five days
  • We have recruited a high proportion of patients to nationally prioritised studies; over one third (32%) of all Covid-19 patients within the Trust have been recruited to Covid-19 national priority studies. 
  • Every patient that has been admitted into the Trust with COVID-19 has been screened for inclusion into a trial

Studies

  • To date, the Trust has taken part in 26 different COVID-19 UPH research studies (16 open to recruitment, 10 in set-up), recruiting 453 patients (as of 24/05/2020)
  • Of these 8 are early phase studies, including:
  1. COVACTA
  2. RUXCOVID
  3. CANCOVID
  4. Ravulizumab
  5. Illiad-7
  6. COPCOV
  7. ACCORD-2
  8. TACTIC
    • Furthermore, we have two further early phase studies which are at Feasibility stage:
      1. AGILE-ACCORD MASTER PLATFORM PROTOCOL
      2. CST-1: A Randomized Phase I/II Study to Determine the Safety and Efficacy of Nomacopan for the Treatment of Patients Hospitalised with COVID-19
      • And we have the following studies which have an experimental/translational research element included:
      1. ISARIC CCP Study
      2. GenOMICC
      3. COVID-19 hyperinflammation syndrome (COV-HI): rapid cohort study
      4. NIHR BioResource COVID-19 call
  • Of the BRC priority platforms, we are involved in IQVIA/ACCORD and TACTIC trial
  • The Trust was also the first in the world to recruit a patient to the Ruxcovid study and the first in the UK to recruit to the Cancovid study.  
  • The Trust is also participating in the NIHR Health Informatics Collaborative (HIC) Covid-19 project via its Real World Data team.

Staff

  • At its peak, the designated Covid research team numbered >70 individuals;
  • All research delivery, BRC Clinical Research Fellows and CRF staff redeployed to work on Covid-19 clinical care and Covid-19 studies three days after lockdown
  • Assoc Prof Sinisa Savic (BRC Immunologist and CRF Bioresource lead) has been the academic lead for the Covid-19 Trials.  In addition, he is PI on 4 the following studies: COVACTA, RUXCOVID, CANCOVID, Ravulizumab and has been involved in setting up national platform TACTIC
  • Prof Chris Twelves (CRF Director) has provided academic oversight for Covid-19 studies.  He is PI for: AGILE-ACCORD MASTER PLATFORM PROTOCOL, CST-1
  • Dr Chris Rooney (BRC affiliated Clinical Research Fellow) was deployed from BRC to full-time Covid-19 studies
  • Dr Helen Radford (CRF Manager) has been the operational lead for the set-up of Covid-19 Trials

Patient and Public Involvement and Engagement

The combined BRC-CRF PPIE groups have been particularly active supporting during the Covid-19 pandemic.  The group:

  • Reviewed all public facing information on Covid-19 trials LTHT was involved with
  • Has linked in with BRC PPIE national initiatives
  • Established a rapid response PPI Group for local Covid-19 studies
  • Is developing a strategy specifically to include BAME Covid-19 PPIE

Of note, our PPIE group has been actively involved in the strategic prioritisation of the re-opening of non-Covid-19 studies and has been involved in the governing principles and will be involved as part of the study prioritisation within Bronze Command team.