Category: Our Research
Delivering COVID-19 research at CUH
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).
Research relating to diagnosis
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 and is now being used in hospitals nationwide. 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.
Research relating to pathogenesis
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.
Research relating to COVID-19 therapy – PLATFORM drug trials
CCRC/CRF staff involved: Areti Bermperi; Jason Domingo; Evgenia Kourampa; Fevie Anne Leal; Vivien Mendoza.
Research relating to COVID-19 follow-up of outcomes
CRF-based COVID follow-up clinics, led by Anne Elmer and Sherly Jose, were established in June 2020, combining NHS and research follow-up. Clinics commenced in August 2020 to capture post-COVID-19 recovery of patients who had been admitted to CUH since March 2020. Over 450 patients had been seen by October 2020 in the nurse-led and medical-led clinics. Some patients with complex needs required consultation with two or more specialities, such as a neurologist or a respiratory consultant. This is now an established pathway and the clinic is able accept GP referrals.
COVID-BioResource follow-up is ongoing. We are recruiting to PHOSP-COVID (NIHR Leicester BRC-led consortium involving 20 universities and associated NHS trusts).
Research relating to COVID-19 prevention
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. This trial involves thousands of visits to the NIHR CRF for screening, dosing (including 2nd doses), follow-up and symptomatic pathway management. Participants are being followed up for 1 year. 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.
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.
In November 2020 over 200 volunteers were recruited and vaccinated, with the second vaccine being given in January/February 2021.
Two different vaccines (Oxford/AstraZeneca and Pfizer/BioNTech) have been used by the NHS to deliver its immunisation campaign against COVID-19. Whilst these have been shown to be highly effective at preventing severe disease due to COVID-19, is it not known how long the immune protection from vaccination will last. In addition, variants of the virus which causes COVID-19 have emerged with mutations which might make the immune response from vaccination less effective. It is therefore likely that additional, “booster” vaccinations might be needed for high risk groups after a period of time to provide added protection.
This Government-funded national trial, led by the University of Southampton, is investigating the effectiveness of seven different COVID-19 vaccines, given as a booster at least 10 weeks after the 2nd dose of the original vaccine, compared to a control (non-COVID-19) vaccine. All the data will be analysed on an ongoing basis, with initial results expected in September 2021.
In June/July 2021 we recruited and vaccinated over 180 volunteers aged over 30 years, who will be followed up for a year to monitor their immune response.
Non-COVID-19 research that continued
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 2020 onwards.
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- Mlcochova P, et al. Combined point of care nucleic acid and antibody testing for SARS-CoV-2 following emergence of D614G Spike Variant. Cell Reports Medicine 2020 doi: 10.1016/j.xcrm.2020.100099
- Jones NK, et al. Effective Control of SARS-CoV-2 Transmission Between Healthcare Workers During a Period of Diminished Community Prevalence of COVID-19. eLife 2020. doi: 10.7554/eLife.59391
- Rivett L, et al. Screening of Healthcare Workers for SARS-CoV-2 Highlights the Role of Asymptomatic Carriage in COVID-19 Transmission. eLife 2020. doi: 10.7554/eLife.58728
- The RECOVERY Collaborative Group Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report. New England Journal of Medicine 2020. doi: 10.1056/NEJMoa2021436.
- Voysey M et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. The Lancet 2021. doi: 10.1016/S0140-6736(20)32661-1
- Török ME et al. Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom. Clinical Trials 2021. doi: 10.1177/17407745211024764