BEAT-CORONA: Building evidence to advance treatments for COVID-19

ISRCTN	ISRCTN89573163
DOI	https://doi.org/10.1186/ISRCTN89573163
EudraCT/CTIS number	2020-002016-48
IRAS number	282317
Secondary identifying numbers	CTU0306, IRAS 282317

Submission date: 22/04/2020
Registration date: 15/07/2020
Last edited: 21/07/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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 March 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.

BEAT-CORONA is a research study that will look at what makes COVID-19 infection more likely or more severe in some individuals, so we can understand how the disease spreads, and its impact on patients and the NHS. It will also help to support studies testing treatments that may prevent or cure COVID-19. In particular, it is focused on vulnerable populations such as kidney patients, vasculitis patients and inflammatory bowel disease patients and healthcare workers who are uniquely exposed to COVID-19 through occupational activities undertaken in diagnosing and treating patients. This study will conduct real-time monitoring of the impact of the outbreak on these groups of people using a smartphone application or the study website. Information will be collected including demographics and clinical data. Findings from this study will help to understand how different people are affected by COVID-19.

Who can participate?
Persons at risk of COVID-19.

What does the study involve?
Participants will be asked to submit information using the study smartphone application at baseline and periodically for as long as the study continues. Notifications and questionnaires will be sent to participants via in-app push notifications.

What are the possible benefits and risks of participating?
The benefits are that they will be contributing to the fight against COVID19 by helping doctors and the NHS to understand how people are affected by COVID19. As this is an observational study there are no risks associated with participation.

Where is the study run from?
Addenbrookes Hospital (UK)

When is the study starting and how long is it expected to run for?
May 2020 to April 2025

Who is funding the study?
Cambridge Biomedical Research Centre (UK)

Who is the main contact?
Unfortunately, this study is not recruiting public volunteers at this time. This is because the research isn’t ready for volunteers yet or the researchers are directly identifying volunteers in certain areas or hospitals. 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

Dr Kerrie Brusby
Public

Cambridge Clinical Trials Unit
Box 401
Cambridge University Hospitals NHS Foundation Trust
Addenbrooke's Hospital
Level 6
Coton House
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Phone	+44 (0)1223 254472
Email	add-tr.beat-corona@nhs.net

Dr Thomas F Hiemstra
Scientific

Cambridge Clinical Trials Unit
Box 40
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

ORCID ID	0000-0002-2115-8689
Phone	+44 (0)1223 336817
Email	tfh24@cam.ac.uk

Study information

Study design	Prospective observational comprehensive cohort study
Primary study design	Observational
Secondary study design	Epidemiological study
Study setting(s)	Internet/virtual
Study type	Screening
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Building Evidence to Advance Treatments - COmpRehensive COhort NAtional COVID-19 Study (BEAT-CORONA)
Study acronym	BEAT-CORONA
Study objectives	The rationale of the study is to understand the epidemiology of COVID-19 infection in vulnerable groups (patients with kidney disease, vasculitis and related auto-immune disorders, inflammatory bowel disease and in the healthcare workforce) and its effect on clinical outcomes and the healthcare service.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	COVID-19 (SARS-CoV-2 infection)
Intervention	Participants will be asked to submit information using the study smartphone application at baseline and periodically for as long as the study continues. Notifications and questionnaires will be sent to participants via in-app push notifications. Baseline data collected will include: baseline demographic data, baseline clinical data (comorbidities, medication, COVID-19 status and symptoms), smoking history and work environment (HCW only). Weekly follow-up data will include COVID-19 status.
Intervention type	Other
Primary outcome measure	COVID-19 status, weekly during pandemic, via smartphone questionnaire
Secondary outcome measures	1. Risk factors for COVID-19 infection, weekly during pandemic, via smartphone questionnaire 2. Prognostic factors for clinical outcomes after COVID-19 infection, weekly during pandemic, via smartphone questionnaire
Overall study start date	06/04/2020
Completion date	30/04/2025

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	Both
Target number of participants	There is no limit on the number of participants for BEAT-CORONA
Key inclusion criteria	At risk of COVID-19
Key exclusion criteria	Unable to provide informed consent
Date of first enrolment	24/08/2020
Date of final enrolment	01/05/2024

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Addenbrookes Hospital

Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust
Hospital/treatment centre

Cambridge Clinical Trials Unit
Addenbrooke's Hospital
Level 6
Coton House
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Phone	+44 (0)1223 348158
Email	cctu@addenbrookes.nhs.uk
Website	http://www.cuh.org.uk/
"ROR"	https://ror.org/04v54gj93

University of Cambridge
University/education

Trinity Lane
Cambridge
CB2 1TN
England
United Kingdom

Phone	+44 (0)1223 337733
Email	researchgovernance@medschl.cam.ac.uk
Website	http://www.cam.ac.uk/
"ROR"	https://ror.org/013meh722

Funders

Funder type

University/education

Cambridge Biomedical Research Centre

No information available

Results and Publications

Intention to publish date	01/05/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	All publications will be approved by the BEAT-CORONA steering group. Reporting of results will be through publication of manuscripts in peer-reviewed journals and oral or poster presentations at relevant National or International meetings. As COVID-19 represents an emerging challenge, interim analyses may be made available via pre-print repositories ahead of publication in peer-reviewed journals or meetings. Audit datasets will be disseminated to relevant organisations with the agreement of the BEAT-CORONA steering group. Important findings may be communicated through local or National media as approved by the BEAT-CORONA steering group and Sponsor Communications teams. All publications will be approved by the BEAT-CORONA SG. Reporting of results will be through publication of manuscripts in peer-reviewed journals and oral or poster presentations at relevant National or International meetings. As COVID-19 represents an emerging challenge, interim analyses may be made available via pre-print repositories ahead of publication in peer-reviewed journals or meetings. Audit datasets will be disseminated to relevant organisations with the agreement of the BEAT-CORONA steering group. Important findings may be communicated through local or National media as approved by the BEAT-CORONA steering group and Sponsor Communications teams.
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Editorial Notes

21/07/2020: The recruitment start date has been changed from 01/05/2020 to 24/08/2020.
23/04/2020: Trial’s existence confirmed by Addenbrooke's Charitable Trust.