CORONATION: Coronavirus (COVID-19) multinational observational registry

ISRCTN	ISRCTN17717312
DOI	https://doi.org/10.1186/ISRCTN17717312
IRAS number	282239
Secondary identifying numbers	CCTU0304, IRAS 282239

Submission date: 22/04/2020
Registration date: 23/07/2020
Last edited: 07/08/2020

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

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.

Study website

Contact information

Dr Kerrie Brusby
Public

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

Phone	+44 (0)1223254472
Email	add-tr.coronation@nhs.net

Dr Thomas F Hiemsra
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	Observational epidemiological 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	Coronavirus (COVID-19) Multinational observational registry (CORONATION)
Study 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(s)	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
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
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 study start date	06/04/2020
Overall study end date	24/04/2025

Eligibility

Participant type(s)	Patient
Age group	All
Sex	Both
Target number of participants	There is no limit on the number of participants
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 exclusion criteria	Does not meet inclusion criteria
Recruitment start date	30/07/2020
Recruitment end date	24/04/2024

Locations

Countries of recruitment

Afghanistan
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia
Bonaire Saint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cabo Verde
Cambodia
Cameroon
Canada
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo
Congo, Democratic Republic
Cook Islands
Costa Rica
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Côte d'Ivoire
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
England
Equatorial Guinea
Eritrea
Estonia
Eswatini
Ethiopia
Falkland Islands
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Holy See (Vatican City State)
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Korea, North
Korea, South
Kosovo
Kuwait
Kyrgyzstan
Lao People's Democratic Republic
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macao
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia, Federated States of
Moldova
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
Netherlands Antilles
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
North Macedonia
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestine, State of
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Romania
Russian Federation
Rwanda
Réunion
Saint Barthélemy
Saint Helena, Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Martin (French part)
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Sint Maarten (Dutch part)
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and the South Sandwich Islands
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Sweden
Switzerland
Syria
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkmenistan
Turks and Caicos Islands
Tuvalu
Türkiye
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States Minor Outlying Islands
United States of America
Uruguay
Uzbekistan
Vanuatu
Venezuela
Viet Nam
Virgin Islands, British
Virgin Islands, U.S.
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Åland Islands

Study participating centre

Addenbrookes Hospital

Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust
Hospital/treatment centre

Cambridge Clinical Trials Centre (CCTU)
Addenbrooke’s Hospital
Cambridge Biomedical Campus
Box 401
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	24/04/2026
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 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 plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Editorial Notes

07/08/2020: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/09/2020 to 30/07/2020.
2. The United Kingdom was removed from countries of recruitment.
06/08/2020: The following changes were made to the trial record:
1. The trial website was changed from "https://coronation.medschl.cam.ac.uk/"; to "https://coronation-registry.org/";.
2. The countries of recruitment were added to include all countries in the world.
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.