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Defining the disease course and immune profile of COVID-19 in the immunosuppressed patient (DeCOmPRESS study)

The DeCOmPRESS study will rapidly inform management of immunosuppressed patients who contract COVID-19 by defining the natural history and immunological manifestations of the disease in these patients. Its first report will be delivered within 3 months. We aim to address the question of whether being on immunosuppressant therapy for chronic autoimmune disease protects against the cytokine storm associated with COVID-19 and reduces the severity of the clinical syndrome, thereby paradoxically improving rather than worsening clinical outcome. We shall achieve this by studying a large existing inception cohort comprising 70% of patients with systemic vasculitis in Ireland, to compare COVID-19 severity and immunological response between those taking immunosuppression and those on no/minimal immunosuppression. 850 patients have provided consent for periodic blood sampling and data collection for investigation of infection in vasculitis, so no additional ethical approval or consent process is required. Of these, we estimate that we will be able to sample 306 who develop COVID-19 over the next year (153 in the next 3 months). We will obtain a granular clinical dataset, which will be linked to an existing clinical phenotype and blood samples analysed by flow cytometry and ELISA to define the immunophenotype and cytokine profile. The results will be disseminated rapidly to patients via a smartphone app, to the healthcare community via a series of weekly updates, to the public health infrastructure in Ireland through appropriate reporting channels, and to the WHO via their media centre. Importantly, use of a FAIR COVID-19 dataset (designed to be interoperable with international data collection initiatives) and deposition of data in an open science repository will allow ready integration with other studies to maximise the impact of this project. Thus, this study will rapidly deliver critical information on how patients with autoimmune and chronic inflammatory diseases should be managed during this pandemic.