We are a UK-wide consortium of doctors and scientists committed to answering urgent questions about COVID-19 quickly, openly, and for the benefit of all.
The UK needs a coordinated response to answer these questions as quickly as possible. Over the last 8 years we have been preparing for such a major outbreak worldwide International Severe Acute Respiratory Infection Consortium Clinical Characterisation Protocol; our team deployed immediately and has been collecting data and samples since the first cases were reported in the UK.
ISARIC 4C is funded by a grant from UKRI (MRC) with a total value of £5.9M to JK Baillie (PI), University of Edinburgh; MG Semple, University of Liverpool; and P Openshaw, Imperial College London (co-leads). Full list of investigators and specific deliverables.
We are funded to obtain serial samples from 300 cases and single samples for a further 1000. A full list of samples can be found in the UK clinical characterisation protocol. This is a generic, sleeping protocol that is designed to give fast responses with global harmonisation during outbreaks.
We will share samples to get answers as fast as possible. We will not end this outbreak sitting on a biobank; our intention is to use every drop of every sample, now, to have the biggest possible impact on the COVID-19 crisis. Any investigators with the ability to contribute can access our data and samples. The ISARIC-4C study will provide a foundation for other studies, such as clinical trials of new treatments, to help better understand the best way to use interventions.
ISARIC 4C is one the UK-wide NIHR Urgent Public Health Priority studies for hospitalised patients with COVID-19:
ISARIC Clinical Characterisation Protocol (CCP) Tier 0 (CO-CIN)
Data collection, no consent
COVID19 Clinical Information Network (DHSC-funded). Near real-time analysis and reporting of the clinical characteristics of patients admitted to hospital with SARS-CoV-2 infection, to inform the research and public health responses. To achieve this we need clincal research nurses and administrators to gather data from clinical notes and enter it into a simple online database.
ISARIC Clinical Characterisation Protocol (CCP) Tiers 1/2 (4C)
Sample collection, consent needed
COVID19 Clinical Characterisation Consortium (MRC-funded). Obtaining research samples. Either one sample set at recruitment, or 4 sample sets on Day 1, 3, and 9 and (if possible) another set 28 days after discharge. Aims to understand transmission, pathogenesis, and prognosis. To achieve this we need PPE-trained research nurses to obtain consent, and samples of pathogen shedding sites and blood.
Adaptive platform drug trial, consent needed
Randomised Evaluation of COVID-19 Therapy (MRC/DHSC-funded). Trial of widely available, high-priority interventions, among confirmed COVID19 cases requiring hospital admission, to determine effect on death or requirement for invasive ventilation. Interventions will be added and removed over time as needed. Given the unprecedented impact COVID 19 will have on the health of the population, even small clinical benefits may be of significant benefit. Designed to give individual patients the best chance of getting an effective therapy. To do this we need GCP-trained research nurses to support front-line clinical staff recruiting patients.
Adaptive platform trial of supportive care interventions, consent waived
RECOVERY-RS is a multi-centre, pragmatic clinical trial evaluating the use of CPAP and / or high flow nasal oxygenation to prevent intubation and reduce mortality. Uncertainty about the effectiveness of CPAP / HFNO in COVID-19 have led to conflicting guidance on the use of these interventions. Recruits patients with acute respiratory impairment (FiO2 >0.4 and SpO2 < 94%). Sites may choose to enrol in one or both arms of the trial (CPAP versus standard care, HFNO versus standard care or CPAP versus HFNO versus standard care). Sites are encouraged to contact the co-ordinating centre at RECOVERY-RS@warwick.ac.uk to log their interest in participation.
Genetic study, consent needed
Genetics Of Mortality In Critical Care (MRC/DHSC/FEAT/ICS/Wellcome-funded). UK-wide ICU study to identify variants underlying genetic susceptibility to critical illness with coronavirus, which may help identify new targets for treatment and mechanisms of disease. This study was funded in 2014 and was recruiting across the UK before the pandemic hit.
Bayesian adaptive platform trial, consent needed
A Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia. This is a global platform trial in critical care with multiple arms and domains to test a variety of therapeutic interventions in critically-ill patients.