Condition category
Infections and Infestations
Date applied
22/04/2020
Date assigned
23/07/2020
Last edited
24/07/2020
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 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.

CORONATION is an observational registry which will look at the spread and the severity of COVID-19 in the UK and internationally. By building a database of patients it will allow for the identification of risk factors for disease progression and severity. It will also establish the patterns of disease transmission, and allow for the evaluation of the impact COVID-19 has on the healthcare system.

Who can participate?
All cases of COVID-19.

What does the study involve?
Care teams will collect demographic and clinical data on confirmed COVID-19 cases and enter this information into a database. This will be undertaken through a simple enrollment process and linkage with other datasets.

What are the possible benefits and risks of participating?
Benefits: 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?
April 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.

Trial website

https://coronation.medschl.cam.ac.uk/

Contact information

Type

Public

Primary contact

Dr Kerrie Brusby

ORCID ID

Contact details

Cambridge Clinical Trials Centre (CCTU)
Cambridge University Hospitals (CUH) NHS Foundation Trust
Addenbrooke’s Hospital
Cambridge Biomedical Campus
Box 401
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223254472
add-tr.coronation@nhs.net

Type

Scientific

Additional contact

Dr Thomas F Hiemsra

ORCID ID

http://orcid.org/0000-0002-2115-8689

Contact details

Cambridge Clinical Trials Unit
Box 40
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 336817
tfh24@cam.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CCTU0304, IRAS 282239

Study information

Scientific title

Coronavirus (COVID-19) Multinational observational registry (CORONATION)

Acronym

CORONATION

Study hypothesis

The rationale for this study is to understand the spread and severity of COVID-19 in people across the world.

Ethics approval

Approved 20/07/2020, University of Cambridge Human Biology Research Ethics Committee (17 Mill Lane, Cambridge, CB2 1RX; +44 (0)1223 766894; cb480@admin.cam.ac.uk), ref: HBREC.2020.32

Study design

Observational epidemiological study

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Internet

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

COVID-19 (SARS-CoV-2 infection)

Intervention

The CORONATION registry is a patient-level disease registry capturing identifiable patient data on UK COVID-19 cases and anonymised or identifiable data on international COVID-19 cases.

Care teams will collect demographic and clinical data on confirmed COVID-19 cases and enter this information into a database. This will be undertaken through a simple enrollment process and linkage with other datasets.

Baseline data collected will include baseline demographic data, baseline clinical data (comorbidities, medication, COVID-19 status and symptoms).

Intervention type

Other

Phase

Drug names

Primary outcome measure

Demographic and clinical data on confirmed COVID-19 cases (comorbidities, medication, COVID-19 status and symptoms) collected regularly from participating centres by entering data into an online portal

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

06/04/2020

Overall trial end date

24/04/2025

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All COVID-19 cases are eligible for inclusion (COVID-19 cases that pre-decease the start of the registry are eligible)

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

There is no limit on the number of participants

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/2020

Recruitment end date

24/04/2024

Locations

Countries of recruitment

Albania, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Greece, Iceland, Israel, Italy, Kosovo, Latvia, Lithuania, Macedonia, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Kingdom

Trial participating centre

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust

Sponsor details

Cambridge Clinical Trials Centre (CCTU)
Addenbrooke’s Hospital
Cambridge Biomedical Campus
Box 401
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 348158
cctu@addenbrookes.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.cuh.org.uk/

Organisation

University of Cambridge

Sponsor details

Trinity Lane
Cambridge
CB2 1TN
United Kingdom
+44 (0)1223 337733
researchgovernance@medschl.cam.ac.uk

Sponsor type

University/education

Website

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

Funders

Funder type

University/education

Funder name

Cambridge Biomedical Research Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

All publications will be approved by the CORONATION SMG. 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 CORONATION SMG.
Important findings may be communicated through local or national media as approved by the CORONATION SMG and Sponsor Communications teams.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

24/04/2026

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/07/2020: The following changes have been made: 1. The recruitment start date has been changed from 01/05/2020 to 01/09/2020. 2. The ethics approval information has been added. 23/04/2020: Trial’s existence confirmed by University of Cambridge.