Network

ISARIC – International Severe Acute Respiratory and emerging Infection Consortium

  • Coordination: Prof. Peter Horby
  • Geographic range: 111 countries
  • Members: See full list

About

ISARIC is the earliest initiative to ensure a rapid clinical research response to epidemics, funded in 2011 by the French Institut National de ma Santé et de la Recherche Médicale (INSERM), the UK Medical Research Council (MRC UK), the Bill and Melinda Gates Foundation and Wellcome Trust.

ISARIC is a global federation of 55 research networks spanning 111 countries. ISARIC’s mission is to generate and disseminate clinical research evidence whenever and wherever infectious disease outbreaks occur or are a threat.  Since its inception ISARIC has worked closely with the World Health Organization, supporting and responding to MERS-CoV, avian influenza A/H7N9, Ebola virus, and Zika virus.

ISARIC is currently recruiting to an observational study for severe acute respiratory infection (SARI) in 33 countries (SPRINT-SARI). The ISARIC-WHO clinical characterisation protocol to define the natural history of an emerging pathogen is currently approved in 9 countries. Members of the ISARIC coordinating centre and executive committee are partners in PREPARE, APPRISE, ZIKAlliance, ZikaPLAN and ZIKAction.

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Overall goal

To foster global collaborative patient-oriented research between and during epidemics.

Objectives

To generate and disseminate clinical research evidence whenever and wherever infectious disease outbreaks occur or are a threat.

Activities

Clinical trials

SPRINT – SARI

  • Start date: December 2015- ongoing annually

  • Related outbreak: Severe acute respiratory infection (SARI)
  • Research question:
    • Primary Outcome: To test the feasibility of conducting a global study of SARI.
    • Secondary Outcome: To include detailed information on the consequences of SARI and treatment.
    • Tertiary Outcome: To assess the EARL barriers and enablers to being prepared for and conducting pandemic research on a global level.
  • Study design: 5-day period incidence observational study
  • Target number of inclusions: Open, currently 228 sites in 33 countries
  • Expected outcome: A study platform off which ISARIC can launch a global interventional study.
  • Open access to protocol: SPRINT-SARI

RAPIDE – Rapid Assessment of Potential Interventions & Drugs for Ebola

  • Start date: Completed
  • Research question: To evaluate the impact of Brincidofovir treatment and TKM-Ebola treatment on early mortality in Ebola Virus Disease
  • Related outbreak: Ebola, West-Africa
  • Study design: a treatment evaluation programme for use in EVD was devised using a multi-stage approach (MSA) with two or three stages, including both non-randomised and randomised elements.1
  • Target number of inclusions: N/A
  • Outcome: Due to the small sample size it was not possible to determine the efficacy of brincidofovir for the treatment of EVD. Plus, the study was stopped early.2 Administration of TKM-130803 at a dose of 0.3 mg/kg/d by intravenous infusion to adult patients with severe EVD was not shown to improve survival when compared to historic controls.3
  • Open access to protocol: N/A

REMAP – CAP

ISARIC is a partner in this trial; see the trials under PREPARE.

Other information

In 2011/2012 ISARIC prepared a study protocol for the study of convalescent plasma (CP) in MERS CoV patients. This has been used in Kingdom of Saudi Arabia and related publications are cited below. This work provided the framework for the study of CP in Sierra Leone under Calum Semple & Janet Scott (ISARIC members). 4,5.

When the imported cases occurred in the UK the ISARIC-WHO Clinical Characterisation Protocol was activated and ISARIC wrote a document with Public Health England to advise on treatments for study.

Capacity building

Scope: ISARIC capacity builds through doing studies such as the SPRINT SARI global observational study where new networks have formed around this and new sites have come on board as this is a realistic study that they can take part in.  ISARIC contributes to teaching courses e.g. in China, Africa and at the University of Oxford MSc on International Health & Tropical Medicine.

Target: Open

Timing: Ongoing

Data sharing

Harmonization efforts & Open access to protocols: ISARIC is a federation of research networks, and was the first initiative to focus on the development of harmonised and pre-approved protocols for emerging infectious diseases.

ISARIC was engaged with the WHO efforts resulting in harmonised protocols to study Zika; standardisation and harmonisation outputs include Zika research protocols endorsed by WHO and CONSISE. The process was described in the Lancet6 ISARIC members co-authored a piece of work looking at which tools to use to measure the neurodevelopment of children born with Congenital Zika Syndrome.

ISARIC tools are written to support others in doing their work e.g. development of case report forms, or CDASH coded data dictionaries.

The “clinical characterisation protocol” is a WHO and ISARIC study protocol approved by the WHO ethics review board. This was written for an observational study with or without biological sampling for emerging pathogens. All of ISARIC’s tools are freely available on its website.

Open access to research data: ISARIC data sharing policy

Full data set from Ebola trials have also been made publicly available (the only Ebola trials to have done this to date).

Open access to publications: Published papers are open access; these are communicated via our weekly newsletter or on the website.

Ethical, administrative, regulatory and logistical (EARL) barriers

Scope: The mitigation of EARL barriers has been a focus of ISARIC since its inception. Under one of ISARIC’s Working Groups, that aimed to identify EARLs barriers; this work has been continued under the PREPARE initiative.  There is an EARL component to the ISARIC SPRINT-SARI study. By running studies outside of outbreaks ISARIC aims to minimise these barriers during an epidemic. At least 9 countries and sites have approved the WHO and ISARIC Clinical Characterisation Protocol and are ready to activate the protocol if required for an emerging pathogen.

Other activities

ISARIC intensively collaborates with WHO, including membership of the GOARN Steering Committee and Chairing the research sub group of GOARN; membership of the WHO R&D Blueprint Working Group on vaccine and therapeutic trial designs for epidemics; maintaining the master Clinical Characterisation Protocol; hosting international teleconferences on behalf of WHO on clinical research for Ebola and Zika; and currently working on a Clinical Characterisation Protocol for Yellow Fever.

ISARIC also developed and delivered the training curriculum on Clinical Research During Outbreaks (CREDO), via a University of Oxford and WHO TDR initiative.

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