From March 2020, in partnership with the Eastern Clinical Research Network (CRN), we created large multi-departmental COVID-19 outreach teams to deliver COVID-19 research across Cambridge University Hospitals NHS Foundation Trust (CUH).
COVIDx study (Collier et al)
The SAMBA II, developed by University of Cambridge spinout company Diagnostics for the Real World, is a rapid diagnostic test device which was adapted from HIV field testing to COVID-19 diagnosis.
The COVID-19 Outreach Team, led by Vivien Mendoza, started working with the research collaboration led by Professor Ravindra Gupta from the Cambridge Institute for Therapeutic Immunology and Infectious Disease (CITIID) on 31 March, to investigate whether using the new machines could accurately provide a faster diagnosis than standard testing practices and review how it would affect patient waiting times.
After collecting nose and throat swabs from over 140 patients, the samples were processed using the SAMBA II machine. The researchers found they were able to provide an accurate diagnostic result within 90 minutes, compared to the standard 24-48-hour lab waiting time. SAMBA II was implemented into clinical practice as a point-of-care test for hospital-wide use on 02 May. Read the full news story.
CCRC/CRF staff involved: Areti Bermperi; Ranalie de Jesus; Jason Domingo; Marivic Fabiculana; Sherly Jose; Evgenia Kourampa; Vivien Mendoza; Ciro Pasquale; Marlyn Perales; Phoebe Vargas; Bensi Vergese; Julie Ann Zerrudo.
The COVID-19 Outreach Team, led by Stewart Fuller, established a delivery team in 3 staff testing pods on 06 April 2020, and tested approximately 11,500 staff between April and September, using real-time PCR.
CCRC/CRF staff involved: Karen Brookes; Isabel Cruz; Katie Dempsey; Anne Elmer; Naidine Escoffery; Stewart Fuller; Heather Jones; Carla Ribeiro.
Serology test development
Pre-COVID-19 serum samples from a CRF healthy volunteer study (run by Laura Watson) were provided to enable a local COVID-19 serology test to be developed by Dr Rainer Doffinger (Clinical Biochemistry and Immunology, Cambridge University Hospital (CUH)) and then used to test health care workers across the site.
NIHR COVID-19 BioResource – inpatient recruitment
The COVID-19 Outreach Team, led by Anne Elmer, provided nurses 6 days per week to recruit into and follow-up COVID-19 patients in the COVID-BioResource study across CUH wards/ITU/ED. Approximately 50% of the 500 patients admitted to CUH with COVID-19 were recruited into COVID-BioResource. From 1st October 2020, when the COVID-19 positive admissions started to increase, the COVID-19 Outreach Team re-started recruiting patients on the wards and ITU, led by Vivien Mendoza.
CCRC/CRF staff involved: Areti Bermperi; Jason Domingo; Anne Elmer; Evgenia Kourampa; Fevie Anne Leal; Vivien Mendoza; Ciro Pasquale; Carla Riberio; Giovanni Di Stefano.
NIHR COVID-19 BioResource healthcare worker recruitment.
Laura Watson established a COVID-19 Outreach Team in Clinic 33. Approximately 5,900 staff were tested in partnership with Occupational Health, and recruited into NIHR COVID-19 BioResource between 19 June and 7 August. Read the full news story.
CCRC/CRF staff involved: Areti Bermperi; Jason Domingo; Evgenia Kourampa; Fevie Anne Leal; Vivien Mendoza.
CRF-based COVID follow-up clinics, led by Anne Elmer and Sherly Jose, have been established combining NHS and research follow-up. Some patients with complex needs need to be seen by two or more specialities, such as a neurologist or a respiratory consultant.
Clinics commenced in August 2020 to capture post-COVID-19 recovery of patients admitted to CUH from March 2020 and approximately 200 patients have been seen to date in the nurse-led and medical-led clinics.
COVID-BioResource follow-up is ongoing. We are recruiting to PHOSP-COVID (NIHR Leicester BRC-led consortium involving 20 universities and associated NHS trusts).
We have established a CRF vaccine group to deliver COVID-19 vaccine trials.
Oxford/AstraZeneca COVID-19 vaccine trial (COV-002)
This was the first COVID-19 vaccine trial to start in the UK. A large team was rapidly assembled in early May 2020 from 3 NHS Trusts (CUH, Royal Papworth Hospital NHS Foundation Trust, Cambridge & Peterborough Foundation Trust), the University of Cambridge and the CRN to deliver this complex and challenging trial.
We screened over 500 healthcare workers, of which 302 were enrolled and vaccinated in mid-June. To date there have been over 2,000 visits to the NIHR CRF for screening, dosing (including boosters), follow-up and symptomatic pathway management. Two film crews were present on the first day of dosing, with participants attending every 10 minutes. The full list of contributors from all collaborating organisations, including the CCRC/CRF is available.
Janssen COVID-19 vaccine trial (ENSEMBLE-2)
This trial is being coordinated locally by the Eastern CRN team and facilitated in the CRF by a collaborative team from 2 NHS Trusts, CUH and Cambridge & Peterborough Foundation Trust.
Since November 2020 over 200 volunteers have been recruited and vaccinated, with the second vaccine being given in late January / early February 2021.
Approximately 80 ‘never stop’ clinical trials, mainly in cancer, continued on 3 units in the CCRC during the early phase of the pandemic, ensuring that patients continued to receive potentially life-saving experimental drugs. Study re-starts and new studies started up from the summer onwards.