Condition category
Infections and Infestations
Date applied
28/05/2020
Date assigned
01/06/2020
Last edited
07/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

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.

Trial website

https://www.trackcovid.org.uk

Contact information

Type

Scientific

Primary contact

Prof Emanuele Di Angelantonio

ORCID ID

Contact details

Strangeways Research Lab
Worts Causeway
University of Cambridge
Cambridge
CB1 8RN
United Kingdom
+44 (0)800 021 7182
helpdesk@trackcovid.org.uk

Type

Public

Additional contact

Dr Amy McMahon

ORCID ID

Contact details

Strangeways Research Lab
Worts Causeway
University of Cambridge
Cambridge
CB1 8RN
United Kingdom
+44 (0)800 021 7182
helpdesk@trackcovid.org.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2.0; IRAS 283239

Study information

Scientific title

TRACK-COVID: a population-based epidemiological investigation of COVID-19 virus infection

Acronym

TRACK-COVID

Study hypothesis

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

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

Study design

Longitudinal observational study

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Community

Trial type

Screening

Patient information sheet

https://www.trackcovid.org.uk/files/2020/05/Appendix-14-TRACK-COVID-study-PIS-v1.0-22.04.2020-2.pdf

Condition

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

Phase

Drug names

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 trial start date

27/03/2020

Overall trial end date

06/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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)

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

90,000

Participant 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

Recruitment start date

17/05/2021

Recruitment end date

17/05/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Cambridge
Department of Public Health and Primary Care Strangeways Research Lab Worts Causeway
Cambridge
CB1 8RN
United Kingdom

Sponsor information

Organisation

University of Cambridge

Sponsor details

School of Clinical Medicine
University of Cambridge
Cambridge
CB2 0SP
United Kingdom
+44 (0)1223 769291
ResearchGovernance@medschl.cam.ac.uk

Sponsor type

University/education

Website

http://www.cam.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Blood and Transplant Research Unit in Donor Health and Genomics

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Health Data Research UK (HDR UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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.

Intention to publish date

17/05/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/07/2020: Contact details updated. 01/06/2020: Trial's existence confirmed by Nottingham Research Ethics Committee 2.