International Severe Acute Respiratory and Emerging Infections Consortium

Lead Research Organisation: University of Oxford

Abstract

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Technical Summary

ISARIC - International Severe Acute Respiratory and Emerging Infection Consortium - is a global initiative aiming to ensure that clinical researchers have the open access protocols and data-sharing processes needed to facilitate a rapid response to emerging diseases that may turn into epidemics or pandemics.
Gathering over 70 networks and individuals involved in research related to the outbreaks of diseases such as bird flu (H5N1), swine flu (H1N1) and SARS, the consortium is trying to understand the causes of severe acute respiratory diseases, discover how illnesses develop and progress in patients, and identify the most efficient treatments and the best way to prevent further transmission.

With an overreaching ambition to change the way in which research is carried out during and between epidemics, ISARIC aims to address the social and ethical issues related to this paradigm change.

Following its launch in December 2011, ISARIC has been established with an online presence as well as a physical presence in its Secretariat, based at the Centre of Tropical Medicine, Oxford as of mid-May 2012. In its first quarter, more than seventy networks and consortia of over 30 countries across six continents expressed an interest in the work of ISARIC, many of which have joined meetings, calls, and teleconferences.
 
Description CREDO Training course
Geographic Reach Africa 
Policy Influence Type Influenced training of practitioners or researchers
URL https://isaric.tghn.org/credo/
 
Description MSc in International Health and Tropical Medicine
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact The course aims to develop students': •knowledge and understanding of the major global health problems in resource limited settings and their potential solutions; •knowledge and skills in research techniques applied in the analysis of global health problems, including quantitative and qualitative research methods, health policy and systems research and public health, with opportunities for training in additional specialist fields; •capacity to critically appraise evidence in global health; •skills and practical experience in researching specific health problems. The ISARIC team run an outbreak simulation exercise on this course, which always receives top marks from the students. Upon completion of the course, students will be equipped to continue to advance their knowledge, understanding and skills further in research or professional practice in the field of global health. In the future it is anticipated that the graduates will assume leadership and research positions within major international health organisations and ministries of health.
URL http://www.tropicalmedicine.ox.ac.uk/msc-international-health-and-tropical-medicine
 
Description Wellcome Trust
Amount £150,000 (GBP)
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 03/2015 
End 02/2018
 
Description ZIKAlliance
Amount € 11,964,209 (EUR)
Funding ID 734548 - ZIKAlliance - H2020-SC1-2016-2017/H2020-SC1-2016-RTD-Zika 
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 10/2016 
End 09/2019
 
Title Ebola MEURI 
Description Dr Carson was a member on the WHO 2018 MEURI group that advised on which drugs should be considered under the MEURI framework for the DRC 2018 outbreak. A number of ISARIC members contributed to the MEURI CRF. 
Type Of Material Model of mechanisms or symptoms - human 
Year Produced 2018 
Provided To Others? Yes  
Impact The MEURI framework facilitated the study of new therapeutics to Ebola patients in a fair and standardised way. 
 
Title Ebola clinical trial design 
Description Professor Horby who has been the ISARIC Chair 2016- 18 and is now the Executive Director/PI of our new funding from BMGF, DfID & Wellcome (2019 -2023) has contributed to the clinical trial design discussions since 2016 with WHO and BMGF. He and Dr Carson have contributed to a number of WHO R&D Blueprint discussions e.g. Road maps, Priority diseases settings. 
Type Of Material Model of mechanisms or symptoms - human 
Year Produced 2018 
Provided To Others? Yes  
Impact Professor Horby has contributed to trial protocols for Ebola that have been used in the DRC 2018/19. 
 
Title ZIKV harmonized research protocols 
Description Work with the World Health Organization (WHO) and other partners, on standardising and harmonising tools and data, has included six epidemiological research protocols developed for WHO by Institut Pasteur Paris Department of Global Health & CONSISE. The six harmonized research protocols cover: Case control study for microcephaly, to be adapted for congenital Zika syndrome; Case control study for Guillain-Barré syndrome; Cohort study of pregnant women; Cohort study of newborns; Virus persistence study in bodily fluids; Cross sectional seroprevalence study of Zika virus in the general population. ISARIC contributed the body of some of the CRFs used and the laboratory algorithms. A 7th research protocol, the Clinical Characterisation Protocol (CCP), has been adapted, by ISARIC and WHO, from the IDAMS dengue multi country study. This natural history protocol aims to better describe the scope of Zika virus infection and is currently undergoing WHO review. 
Type Of Material Improvements to research infrastructure 
Year Produced 2016 
Provided To Others? Yes  
Impact The protocols have been designed to maximise the likelihood that data and biological samples are systematically collected and shared rapidly in a format that can be easily aggregated, tabulated, and analysed across many different settings globally. The data collected using these standardised protocols will be used to refine and update recommendations for prevention of Zika virus spread, surveillance, and case definitions for microcephaly (and other congenital abnormalities related to Zika virus infection), to help understand the spread, severity, spectrum, and impact on the community of Zika virus and to guide public health measures, particularly for pregnant women and couples planning a pregnancy. 
 
Title Zika Case Report Forms 
Description ISARIC convened a Zika Working group early in December to support our regional focal point at Fiocruz in Brazil. Those calls have generated a number of outputs including a zika infection website hosted on the Global Health Network platform. Case report forms for microcephalic babies and pregnant women developed with colleagues from PREPARE Europe. Data dictionaries and consent forms are near completion. All documents will be translated into Spanish, French & Portuguese. We plan to validated these documents in Brazil with end users. Additionally, we are adapting a clinical characterisation protocol with IDAMS (ISARIC member) to describe the natural history of Zika in collaboration with the WHO. 
Type Of Material Improvements to research infrastructure 
Year Produced 2016 
Provided To Others? Yes  
Impact We hope the CRFs will assist with ensuring a minimal data set for Zika and allow for comparison across studies. Additionally, out of the working group a consortium has formed call STARRT - Standardised Rapid Research Tools for Zika. We have applied for MRC funds. 
URL https://zikainfection.tghn.org/
 
Title Zika data dictionaries 
Description Zika data dictionaries to support the Zika Case Report Form portfolio. 
Type Of Material Improvements to research infrastructure 
Year Produced 2017 
Provided To Others? Yes  
Impact Clinical Data Acquisition Standards Harmonization (CDASH) compliant. CDASH establishes a standard way to collect data in a similar way across studies and sponsors so that data collection formats and structures provide clear traceability of submission data, delivering more transparency to regulators and others who conduct data review. 
URL https://zikainfection.tghn.org/research-tools-and-resources/crfs/
 
Title ISARIC database 
Description The ISARIC Database is a secure, central host for all data collected as a part of ISARIC-supported research. The Database includes primary, patient-level data for the global WHO-ISARIC Clinical Characterisation protocol and the Short Period Incidence Study for Severe Acute Respiratory Infections (SPRINT-SARI). Data is submitted by international collaborators under a data sharing agreement which facilitates collaborative data reuse and reporting to public health agencies. The Database structure enables the harmonisation of data to the CDISC (Clinical Data Interchange Standard Consortium) standards, supporting increased data quality and heterogeneity to support meta-analysis. 
Type Of Material Database/Collection of data 
Year Produced 2013 
Provided To Others? Yes  
Impact The security, governance and technical framework of the Database provides a resource for the emerging infections research community to improve patient care and inform policy. 
 
Description Global Outbreak Alert and Response Network (GOARN) Steering Committee 
Organisation World Health Organization (WHO)
Department WHO Global Outbreak Alert and Response Network
Country France 
Sector Charity/Non Profit 
PI Contribution ISARIC has a seat on the GOARN Steering Committee and is leading the Operational Research Working Group. Since the last research fish submission Dr Carson has been elected GOARN Vice Chair.
Collaborator Contribution The contributions are filtered through the Steering Committee and the various working group activities.
Impact The Global Outbreak Alert and Response Network contributes towards global health security by: - combating the international spread of outbreaks - ensuring that appropriate technical assistance reaches affected states rapidly - contributing to long-term epidemic preparedness and capacity building.
Start Year 2016
 
Description ISARIC-WHO Clinical Characterization Protocol for Severe Emerging Infections 
Organisation National Institute for Health Research
Department NIHR CLAHRC Oxford
Country United Kingdom 
Sector Public 
PI Contribution Research team supported the activation week in the UK. The support included enabling eighteen NHS Trust sites to have approvals in place and take part in the activation.
Collaborator Contribution Maintain readiness of site staff, test processes for recruitment, consent and data acquisition. This pre approved protocol performed in 2018 by facilitating the recruitment of 4 patients in the Uk with MERS or Monkeypox within 24 hours of diagnosis.
Impact Local investigators, research nurses and research and development staff.
Start Year 2016
 
Description SPRINT SARI 
Organisation International Forum for Acute Care Trialists (InFACT)
Country Global 
Sector Learned Society 
PI Contribution SPRINT SARI is the ISARIC and InFACT (member of ISARIC) global observational study for severe acute respiratory disease. This study recruits every year as it is part of pandemic preparedness. We are working with the WHO Geneva flu team to make the data collected of use to their PISA system. The ISARIC Global Coordination Centre has been involved since the beginning of this project and will continue to be so. The current PI is Srin Murthy of InFACT in Canada. The ISARIC GSC helped design the study, contribute to supporting documentation and brought on board new sites. The data management will be run out of Oxford from later this year. The MRC were a founding funder of ISARIC hence why this has been added. SPRINT SARI did not start recruiting until 2016.
Collaborator Contribution The management and steering group is made up of ISARIC members from across the globe. All have contributed to the study design, strategy and documentation. The WHO are now interested in utilising this infra structure to assist with their assessment of severity and anti viral resistance for influenza. There is a PEARLS sub study section run by Prof. Alistair Nichol, which will collect the barriers to the observational study.
Impact The study is currently recruiting and we have secured funding for data management. This is multi-disciplinary and includes intensive care doctors and nurses, clinical researchers, data managers, epidemiologists, infectious diseases, public health specialists, project managers and virologist/microbiologists. There is a data sharing component to this project and the ISARIC database will be utilised. Over 900 patients have been enrolled. A paper is in press presenting some of the data.
Start Year 2014
 
Title Brincidofovir 
Description This study was terminated by the company. Reference is elsewhere in the submission. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2015
Development Status Closed
Clinical Trial? Yes
UKCRN/ISCTN Identifier Pan African Clinical Trials Registry PACTR201411000939962
Impact The study was closed by the company and we were never told why. However, this was the first Ebola or emerging pathogen clinical trial we have set up and run during an outbreak. This fact was an achievement and it lay the ground work for the TKM study that followed in Sierre Leone. 
 
Title TKM Ebola 
Description The study was stopped early when it met the statistical futile cut off. The reference is elsewhere in the submission. 
Type Therapeutic Intervention - Drug
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2015
Development Status Closed
Clinical Trial? Yes
UKCRN/ISCTN Identifier Pan African Clinical Trials Registry PACTR201501000997429.
Impact Again the fact that we latched this study during an ebola outbreak was an achievement and we did so quickly than the BCV study. 
 
Description Cheltenham Science Festival 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Public engagement activity: faced by an outbreak of Zika virus, a global health threat and potential public health emergency, we invited visitors to the Cheltenham Science Festival to consider the vector, detection of the virus and the consequences of infection, by hosting a journey on our stand. This included Zika educational games for school children visiting the stand.
Year(s) Of Engagement Activity 2015,2016
URL https://www.ndm.ox.ac.uk/cheltenham-science-festival-2016
 
Description ISARIC weekly newsletter 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact We release a weekly newsletter to our membership, via our website and Twitter account.
This summarises key clinical research related initiatives from around the world but related to emerging pathogens.
A list of recent publications that might be of interest, funding calls and relevant meetings.
Year(s) Of Engagement Activity 2015
URL https://isaric.tghn.org
 
Description Masters student now Phd student presented Zika masters project at IMED 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dr Delphine Kayem did her masters project with ISARIC on Zika core data variables. She presented this at IMED 2018.
Year(s) Of Engagement Activity 2018
 
Description Outbreak, the clinical research response 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Meet the researchers initiative through the Nuffield Department of Medicine to share research interests with fellow researchers.
Year(s) Of Engagement Activity 2016
URL https://www.ndm.ox.ac.uk/gail-carson-outbreak-the-clinical-research-response
 
Description Sponsored the NCDC Lassa Conference Abuja 2019 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact ISARIC co sponsored the Lassa conference hosted by the Nigerian Centre for Disease Control.
We were engaged in the discussions and are part of the Nigerian Lassa Research consortium.
We have also, contributed to the National Lassa Research Plan.
Members from the GSC are collaborators on planning for a treatment trial.
Year(s) Of Engagement Activity 2019
 
Description Zika Working Group 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Provided a neutral platform that enables frank and timely exchange between all its partners. The Zika Working Group was first convened in December 2015 and has since held 21 teleconferences. Connected regional platforms and provided a global facilitatory function to enable the exchange of knowledge, ideas and capacity. ISARIC has been instrumental in the discussion with WHO and other global partners on the creation of a core outcome set/guidelines for the neurodevelopmental consequences of Zika virus infection for global use.
Year(s) Of Engagement Activity 2015,2016,2017