Blood and genetic markers of COVID-19 to accurately measure illness severity and predict the risk of becoming seriously ill

Overview: An improved range of diagnostics is needed to better understand the degree of illness, likelihood of illness, associated risk and priority triage of the most critically ill patients. This program will carry out validation of currently known potential biomarkers for use in TGA approved diagnostic tests to predict disease progression in severe respiratory viral infections in front line fever clinic, emergency departments and ICUs. This will allow fast identification of high-risk COVID-19 patients and rapid referral to ICU, and will in turn increase efficiencies by prioritising allocation of ICU resources to the most critically ill. Objectives Enrol patients with confirmed or suspected COVID-19 or sepsis/respiratory infection in selected Hospital Emergency Departments to determine whether they are at risk of severe COVID-19 disease and need immediate triage to intensive care, or can be transferred to hospital ward, or home management; Validate biomarkers already successfully deployed previously for predicting disease progression in severe respiratory viral infections; We will analyse and validate additional candidate biomarkers detected using novel RNA seq methodology; Provide baseline data for a clinical trial of respiratory virus biomarker assays for patient triage. Research Plan Patients with confirmed or suspected COVID-19 or sepsis/respiratory infection are being enrolled from Westmead and Nepean Hospitals and blood samples from these patients are being analysed to identify the immune signature that predicts which patient will develop COVID-19 complications (e.g. pneumonia). Biomarkers already successfully deployed previously for predicting disease progression in severe respiratory influenza cases are being examined. In addition, candidate biomarkers specific for COVID-19 are being identified using novel RNA sequencing methodology, analysed and validated for use in screening and triage of patients infected with SARS-CoV-2. From the same data we will examine the dynamics local cytokine (gene expression) profiles of COVID-19 patients. Test validation is being carried out in a primary cohort (n=200) with expansion to identification of COVID-specific immune signatures in a large number of samples (total = 650). We will work with other scientists, public hospitals laboratories and health authorities to develop the assay prototype and test it in hospital laboratories. Study sites: Westmead Hospital, Nepean Hospital, others TBA