Investigation of COVID-19 symptoms and potential immunity in the general population
ISRCTN | ISRCTN55886926 |
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DOI | https://doi.org/10.1186/ISRCTN55886926 |
IRAS number | 283239 |
Secondary identifying numbers | 2.0; IRAS 283239 |
- Submission date
- 28/05/2020
- Registration date
- 01/06/2020
- Last edited
- 07/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of April 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
This study aims to track up to 90,000 individuals across England to provide scientists and national decision-makers with detailed information to help control and understand the COVID-19 pandemic. The study will investigate why some people have COVID-19 symptoms and others don’t, and determine the risk factors for infection. It will help to determine the extent of infection in the general population and help to design new ways to prevent and treat such infections.
Who can participate?
Individuals who participated in the INTERVAL, COMPARE or STRIDES BioResource studies
What does the study involve?
Participants will be asked to provide monthly questionnaire information and a subset of willing participants will be asked to provide monthly fingerprick blood samples.
What are the possible benefits and risks of participating?
There are no direct benefits to the study participants. The findings from this study will be discussed with key government agencies responsible for helping with the COVID-19 pandemic (e.g., Public Health England). There is no risk associated with participation.
Where is the study run from?
University of Cambridge (UK)
When is the study starting and how long is it expected to run for?
March 2020 to June 2021
Who is funding the study?
University of Cambridge (UK)
Who is the main contact?
Unfortunately, this study is not recruiting public volunteers at this time. Please do not contact the research team as they will not be able to respond. For more information about COVID-19 research, visit the Be Part of Research homepage.
Contact information
Scientific
Strangeways Research Lab
Worts Causeway
University of Cambridge
Cambridge
CB1 8RN
United Kingdom
Phone | +44 (0)800 021 7182 |
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helpdesk@trackcovid.org.uk |
Public
Strangeways Research Lab
Worts Causeway
University of Cambridge
Cambridge
CB1 8RN
United Kingdom
Phone | +44 (0)800 021 7182 |
---|---|
helpdesk@trackcovid.org.uk |
Study information
Study design | Longitudinal observational study |
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Primary study design | Observational |
Secondary study design | Epidemiological study |
Study setting(s) | Community |
Study type | Screening |
Participant information sheet | https://www.trackcovid.org.uk/files/2020/05/Appendix-14-TRACK-COVID-study-PIS-v1.0-22.04.2020-2.pdf |
Scientific title | TRACK-COVID: a population-based epidemiological investigation of COVID-19 virus infection |
Study acronym | TRACK-COVID |
Study objectives | To understand the frequency and evolution of symptoms compatible with COVID-19 and to define and monitor the evolution of population immunity by assay of biomarkers (e.g., IgG antibodies to SARS-CoV-2). |
Ethics approval(s) | Approved 04/05/2020, Nottingham Research Ethics Committee 2 (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8035, +44 (0)207 104 8103; nottingham2.rec@hra.nhs.uk), ref: 20/EM/0121 |
Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) symptoms and seroprevalence in the general population |
Intervention | Participants will be asked to provide monthly online questionnaire information for 12 months. The questionnaire will ask about COVID-19 related symptom experiences within last month, current medication as well as questions related to wellbeing. A subset of participants will be asked to provide a monthly blood sample (obtained at home via finger prick) for 12 months. |
Intervention type | Other |
Primary outcome measure | 1. Symptoms compatible with COVID-19 measured using online questionnaire information monthly for 12 months 2. Population immunity measured using assay of biomarkers (e.g., IgG antibodies to SARS-CoV-2) on blood samples (obtained at home via finger prick) monthly for 12 months |
Secondary outcome measures | 1. Asymptomatic or subclinical infections in the population measured using self-reported questionnaire data monthly for 12 months 2. Immunological evidence of previous SARS-CoV-2 infection measured using antibody tests monthly for 12 months 3. Risk factors for subsequent development of any, mild and severe COVID-19 like illnesses (correlates of protection) measured using self-reported monthly questionnaires with concurrent assessment of SARS-Cov-2 specific antibody levels monthly for 12 months 4. Duration of protection from COVID-19 like illness after confirmed infection, measured using SARS-Cov-2 specific antibody levels monthly for 12 months |
Overall study start date | 27/03/2020 |
Completion date | 06/06/2021 |
Eligibility
Participant type(s) | Healthy volunteer |
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Age group | Adult |
Sex | Both |
Target number of participants | 90,000 |
Key inclusion criteria | 1. Have previously taken part in the INTERVAL, COMPARE or STRIDES studies 2. Have an email address for study participation 3. Reside in mainland England 4. Have a good understanding of the English language, both written and oral (study materials are not tailored to support non-English language speakers) |
Key exclusion criteria | 1. Have received three invitations from the INTERVAL/COMPARE/ STRIDES research study team to take part in other studies in the past year 2. Have withdrawn their consent to take part in the INTERVAL/COMPARE/STRIDES study |
Date of first enrolment | 17/05/2021 |
Date of final enrolment | 17/05/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Strangeways Research Lab
Worts Causeway
Cambridge
CB1 8RN
United Kingdom
Sponsor information
University/education
School of Clinical Medicine
University of Cambridge
Cambridge
CB2 0SP
England
United Kingdom
Phone | +44 (0)1223 769291 |
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ResearchGovernance@medschl.cam.ac.uk | |
Website | http://www.cam.ac.uk/ |
https://ror.org/013meh722 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
Intention to publish date | 17/05/2022 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | 1. The study protocol may be published in due course 2. Planned publications in high-end journals following completion of the trial |
IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Sarah Fahle (donorhealth@medschl.cam.ac.uk). Data will be available to other researchers upon review of individual requests. All data will be anonymised. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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HRA research summary | 28/06/2023 | No | No |
Editorial Notes
07/07/2020: Contact details updated.
01/06/2020: Trial's existence confirmed by Nottingham Research Ethics Committee 2.