Cambridge Clinical Trials Unit (CCTU): against COVID-19 ^Laboratory

Entity: Cambridge Clinical Trials Unit (CCTU)

Category: Laboratory

Description: The CCTU is part of the NIHR UKCRC Registered CTU Network and a member of the NCRI Cancer CTU Group. The CCTU was established in 2011 and is hosted at the Cambridge University Hospitals NHS Foundation Trust (CUH) as part of the Cambridge Biomedical Research Centre. The CCTU is part of the NIHR UKCRC Registered CTU Network and receives National Institute for Health Research CTU Support Funding. This funding has been awarded to support the unit in developing and supporting NIHR trials. CCTU is also a member of the NCRI Cancer CTU. Their aim is to work in partnership with researchers to deliver the highest quality clinical trials and clinical research. The unit’s study portfolio covers a broad range of disease areas, mirroring the vast spectrum of research interest within Cambridge University Health Partners.

Project: 'Evaluation of Novel Diagnostic Tests for COVID-19 (COVIDx)'

Summary: COVID-19 originated in the Wuhan China and has since spread to at least 159 countries around the world. The cases in the United Kingdom continue to increase. 1 in 5 people diagnosed will require hospital admission and 1 in 20 intensive care treatment. By developing and improving diagnostic testing, it is possible to accurately diagnose infected cases to triage appropriate treatments, identify individuals for quarantine in order to prevent transmission and obtain information regarding patient’s immune systems. At present, the diagnostic test is a highly specific method of genetic amplification called ‘Reverse Transcription – Polymerase Chain Reaction’ which allows detection of very small amounts of genetic mutations caused by COVID-19. This method must be completed in highly specialised facilities, increasing time to diagnosis, increasing exposure to non-infected individuals, and overburdening the analysing facilities. The ideal solution is a point of care (POC) test that can give results immediately. This study aims to harness the point of care technology of the SAMBA II device (Diagnostics for the Real World Ltd.), by amplifying genetic material, and Prometheus 2019-nCOV IgG/IgM Test Cassette, by identifying antibodies (both CE marked). In the COVIDx study, 200 patients meeting with suspected COVID-19 will be recruited and a sample from throat and nasal swab taken and tested using the SAMBA II method. A combination of the standard PHE RT-PCR and an additional validated laboratory PCR technique will be used as a control in line with standard care. Patients will undergo an additional serum tests on existing samples as made available after routine clinical assessments to monitor antibodies. Patients will be followed for clinical outcomes at 28 days post-admission. Once validated, the team will move to a second cohort of healthcare workers with the hope of quick identification of infection and maximising the available workforce to combat the pandemic.

Research type: Clinical investigation or other study of a medical device

Contact name: Professor Ravindra Gupta

Sponsor: Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge