Study Protocol for DeCOmPRESS: Defining the Disease Course and Immune Profile of COVID-19 in the Immunosuppressed Patient

Abstract

The ongoing coronavirus disease 2019 (COVID-19) pandemic is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Current advisory guidelines for high-risk groups—including people with autoimmune disease taking immunosuppressive therapies—are to take increased precautions and avoid any unnecessary contacts. The aim of the DeCOmPRESS study is to define the disease course and immune profile of COVID-19 in immunosuppressed patients. We will clinically phenotype patients with ANCA-associated vasculitis (AAV) who develop COVID-19 using a customized REDCap data collection instrument embedded within the Rare Kidney Disease (RKD) Biobank. This dataset will be interoperable with the rheum-COVID, Global Rheumatology Alliance, and SPRINT-SARI datasets, facilitating international data linkage. Acute and convalescent blood samples will be analysed by flow cytometry and ELISA to define the immunophenotype and cytokine profile. Patients will track COVID-19 and AAV symptoms through a bespoke smartphone app. DeCOmPRESS study findings 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. We will also determine whether pre-existing immunosuppressant therapy lessens the cytokine storm associated with severe COVID-19 disease, thereby paradoxically improving rather than worsening clinical outcomes. This protocol document details the procedures for end-to-end completion of the DeCOmPRESS project and is complemented by an associated comprehensive Study Manual (accessible at: https://www.tcd.ie/medicine/thkc/decompress/).