ISARIC - Coronavirus Clinical Characterisation Consortium (ISARIC-4C)

This COVID-19 Rapid Response award is jointly funded (50:50) between the Medical Research Council and the National Institute for Health Research. The figure displayed is the total award amount of the two funders combined, with each partner contributing equally towards the project. It seems highly likely that SARS-CoV-2 will cause disease and mortality unprecedented in modern times. Despite rapid publication of data from China, many unanswered questions remain that have immediate bearing on control and treatment of COVID-19: • Pathogen: how does transmission occur and over what period? What features of the virus drive transmission and severity? • Host: How can diagnosis be improved? How can severity be predicted? Does prior immunity to other viruses worsen disease severity? How does (non)pulmonary organ injury occur? Can therapy be tailored according to disease mechanisms? Which bacterial or fungal co-infections contribute to critical illness? This is a new disease. There is a high chance that clinical trials will fail to detect therapeutic effects, by enrolling at the wrong time, or missing key subgroups or endpoints. Deep biological phenotyping can mitigate these risks, providing rapid, efficient clinical evidence. Our response has been planned and tested over the past 8 years within the International Severe Acute Respiratory Infection Consortium (ISARIC). We will recruit at least the first 1300 consenting UK patients, and 1000 suspected cases, as the base of a coordinated national response, using our established, internationally-harmonized protocol (ISARIC Clinical Characterisation Protocol) to: • Provide a unified foundation for clinical trials, enriching design and interpretation • Provide an open-access platform for evaluation of diagnostics and therapeutics • Establish a sample repository with independently-managed availability to researchers and to industry. • Use real-time data to inform the response by funders, public health and hospitals ISARIC-4C is a consortium of experts with a proven track record of high-quality outbreak research. We have already recruited 87% of cases reported in the UK.