TRACK-COVID [COVID-19]
Research type
Research Study
Full title
TRACK-COVID: a population-based epidemiological investigation of COVID-19 virus infection\n
IRAS ID
283239
Contact name
Emanuele Di Angelantonio
Contact email
Sponsor organisation
University of Cambridge
ISRCTN Number
ISRCTN55886926
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
Coronavirus induced disease (COVID-19) has now been declared a global pandemic by the World Health Organisation (WHO); efforts are in progress to understand its epidemiology and identify treatments and vaccines. As initial disease surveillance efforts in the UK have focused principally on patients with severe disease, however, there is an unmet need for complementary efforts that provide national data on the full spectrum of the disease, including the extent and fraction of mild or asymptomatic infections that do not require medical attention.\n\nHere we propose to help meet this need by conducting periodic surveys of approximately 80,000 participants already consented into three inter-linked research cohorts (i.e., INTERVAL, COMPARE and STRIDES; 11/EE/0538, 15/EE/0335 and 18/EE/0284, respectively) who have agreed to be re-contacted for invitation to additional biomedical studies. The overall concept is to conduct a two-stage study to help monitor the evolution of immunity to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the new coronavirus, and to help define its key epidemiological and serologic characteristics across a wide sample of the population resident across the geographical breadth of England.\n\nParticipants previously recruited into the INTERVAL, COMPARE and STRIDES studies should provide an efficient and highly informative sampling framework for such COVID-19 surveillance because: \n• participants have already consented for re-contact; \n• participants’ personal details (e.g., email addresses) are already available for rapid contact; \n• participants are demographically diverse (e.g., aged 18-80 years at entry) and recruited from >30 sites across the geographical breadth of England\n• extensive (pre-pandemic) data are available on the participants in relation to biological, behavioural, clinical and other characteristics, which should enable rapid identification of potential risk factors (or, conversely, resilience factors) for immunity and adverse outcomes of COVID-19;\n• pre-pandemic biological samples (e.g., serum, plasma) are stored for these individuals, enabling comparison of pre- and post-pandemic SARS-CoV-2 antibody titres.\n\nDuring the first stage of this effort, individuals will be invited via email to participate, and will be sent a participant information booklet via web link. For participants who agree to participate, they will be asked to complete a consent form electronically, and be sent an online questionnaire on a monthly basis. During the second stage, participants expressing an interest in providing biological samples (e.g., finger-prick capillary whole blood sample) will be contacted and asked to provide self-collected samples on a monthly basis over a period of 12 months. We will submit an amendment to this study for stage two as biological sample of choice has not been finalised due to the fast moving pace of the pandemic and associated assay technology.\n\nThe impact of this effort will immediate: it will, for example, directly inform public health modelling, feeding into the Scientific Advisory Group for Emergencies (SAGE) in order to help better control and understand the COVID-19 outbreak.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0121
Date of REC Opinion
4 May 2020
REC opinion
Favourable Opinion