SARS-CoV-2 Longitudinal Study (Legacy Study) [COVID-19]
Research type
Research Study
Full title
SARS-CoV-2 Longitudinal Study: Understanding Susceptibility, Transmission and Disease Severity (Legacy Study)
IRAS ID
286469
Contact name
Charles Swanton
Contact email
Sponsor organisation
UCLH
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
The study aims to use residual specimens from an existing collection of samples from the Crick COVID-19 Consortium Testing Centre and to collect additional biological material for research into COVID-19 transmission, evolution and immune control. These samples would otherwise be discarded. The study will also allow for collaborative work with other REC approved research studies that have used the Testing Centre and will involve the use of study samples already collected from each study to be analysed under this study's endpoints.
There will cohorts A1, A2, B and C:
Cohort A1 will incorporate residual samples (no longer required for diagnostic testing) from the Testing Centre and the relevant medical records of these participants without the need to consent them for this study.
Cohort A2, informed consent will be obtained from 3,000 SARS-CoV-2 positive and 3,000 SARS-CoV-2 negative participants within the A1 cohort to collect additional nose and throat swabs, blood samples for SARS-CoV-2 analyses including DNA and RNA analyses.
Cohort B, employees at participating centres who had blood (serum) sampled and/or swabbed for SARS-CoV-2 will be prospectively consented for access to residual swab material and serology samples as well as the collection of additional bloods for SARS-CoV-2 analyses including DNA and RNA analyses.
Cohort C, we will access samples from other REC approved studies that have used the Testing Centre. These samples will be analysed under this study's endpoints and clinical datasets for these participants will be obtained via NHSx and/or NHS Digital. The type of samples retained from each study will be determined by the study specific protocol.
This research study would significantly add to our understanding of SARS-CoV 2 susceptibility, transmission, and disease severity in healthcare workers and patients. By understanding disease transmission patterns between healthcare workers, staff and patients and viral evolution, public health measures can be enacted that will limit future spread of a resurgent coronavirus pandemic. Our study also provides an ideal platform for developing and optimizing assays and methodologies for the detection and characterization of the virus, and the host immune response, that can be deployed rapidly into clinical practice that will be required to fully suppress on-going viral transmissions in the workplace. Finally, this large longitudinal cohort will serve as a critical national resource to validate findings from smaller studies to drive clinical advances in this disease. [Study relying on COPI notice]
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
20/HRA/4717
Date of REC Opinion
25 Nov 2020
REC opinion
Further Information Favourable Opinion