On 31st December 2019, the World Health Organization (WHO) was informed of a cluster of cases of pneumonia of unknown cause in Wuhan City, Hubei Province of the People’s Republic of China. The etiologic agent has been identified as a novel Betacoronavirus (2019-nCoV). Cases of infection with 2019-nCoV have been detected in travellers to Thailand, Japan, Korea and the US, and, on 19th January, the case numbers reported from China increased significantly. The emerging data suggest that person-to-person transmission is occurring, and there is a threat of further escalation and international spread.
In the past, clinical data on emerging infections have not been collected, standardised, or shared quickly enough to inform the outbreak response and patient care. ISARIC – whose Global Support Centre is hosted by the University of Oxford - has a long-standing programme of work on emerging respiratory pathogens which is being adapted for the current outbreak.
Standardised clinical data collection and curation
Based on a pre-existing ISARIC global observational study of severe acute respiratory infections (SPRINT-SARI), ISARIC has adapted the case record form (CRF) to assist with the collection of standardised clinical data on patients hospitalised with suspected or confirmed infection with nCoV. This CRF will be made available via WHO and other open-access sources as a global resource for public health purposes. A data management platform will be offered by the ISARIC Global Support Centre.
Clinical observational studies
Based on a pre-existing ISARIC Clinical Characterisation Protocol, the federation is making available an observational clinical protocol (with associated patient information leaflets and consent form) that allows data collection that is harmonised with standardised clinical data collection and curation, and sequential biological sampling for research purposes. A data management platform will be offered by the ISARIC Global Support Centre.
Clinical trials of therapeutics
The federation is working with ISARIC partners and with WHO on developing and implementing clinical trials for therapeutics for 2019-nCoV. These are randomised controlled trial protocols.
This work is being supported by a wide range of ISARIC partners and the ISARIC Global Support Centre, as a global resource. Professor Peter Horby, Executive Director of ISARIC, said:
Patients are at the heart of every outbreak. Our work gives local teams the tools they need to react quickly and effectively to this outbreak, doing vital research to advance understanding and improve patient care.
ISARIC stands by the Principles of Data Sharing in public health emergencies as defined through work led by the funders consortium GloPID-R. As such, ISARIC commits to underpinning implementation of timely data sharing. ISARIC is a global federation of clinical research networks, providing a proficient, coordinated, and agile research response to outbreak-prone infectious diseases. ISARIC’s mission is to generate and disseminate clinical research evidence for outbreak-prone infectious diseases, whenever and wherever they occur. ISARIC is funded by the Wellcome Trust, the UK Department for International Development, and the Bill & Melinda Gates Foundation.
- Read a commentary piece co-authored by Professor Peter Horby.
- Read the first published clinical report of 2019-nCoV cases, published in the Lancet. ISARIC case record forms were used and are acknowledged in Methods.
- New Novel Coronavirus Resource: standardised case report forms and database, an international resource to facilitate the collection of multi-site standardised clinical data on patients hospitalised with suspected or confirmed infection with 2019-nCoV.
- Visit our Coronavirus outbreak knowledge hub