A-249 Theranostic Algorithm: sensitivity and Specificity of a Composite Index Test for Guiding Treatment in Severe COVID-19

Abstract Background Since the outbreak of pandemic, severely affected COVID-19 patients receive standard care at intensive unit (ICU), but clinical trials are still ongoing for new expensive treatments. There is a need guiding therapeutic decisions to restrain public healthcare costs and target most efficient therapy. Based on pathophysiology SARS-CoV-2 its ACE2-receptor, angiotensin pathway activated circulating biomarkers interest can be measured. This diagnostic test accuracy study describes how classify in severe vs mild cases with intention treatment decisions, prevent long term sequels like pulmonary fibrosis. A theranostic approach proposed, which combines vitro diagnostics personalized therapeutics. Methods N = 17 acute respiratory distress syndrome (ARDS) ICU were included compared 7 or asymptomatic 10 healthy controls. Follow-up samples have been collected during pulmonology consultation three time points one year post-ICU (N 39). Non-parametrical statistics used; data expressed as [median (IQR)] P < 0.05 considered statistically significant. The biological markers angiotensin-(1-7) (Ang-(1-7)), transforming growth factor beta (TGF-β), ferritin, C-reactive protein (CRP from Roche) Krebs von den Lungen 6 (KL-6 Fujirebio) measured plasma samples. Those represent disequilibrium lung protection, fibrogenesis, inflammation hyperplasia alveolar epithelial cells type II. Cut-off composite index was obtained through receiver operating curve (ROC). Results show higher Ang-(1-7) concentrations than controls (P 0.05). Critical deficit [124 pg/mL (81–154)], [147 (138–201)] insufficient eligible substitution therapy novel therapies beside care, while subpopulation high analyzed including TGF-β, ferritin CRP. <34 differentiates having (sensitivity 100%, specificity 80%, AUC 0.933, LR 5). without risk not treatment.After 1 year, KL-6 (<275 U/mL) TGF- β (<34 968 pg/mL) normalise only 25%, respectively 33% patients. Within first FU post-ICU, mean value patient population does significantly change different measuring moments 0.63), TGF-β decreases gradually 3, 12 months 0.0001). Conclusion algorithm predicts whether infected by developing complications supports decision making concerning supported choice, based objective biomarker measurements, could diminish long-term sequelae Clinical using companion drugs (e.g. therapy, MAS-receptor agonist), anti-fibrotics, interferon monoclonal antibodies, also rely those biomarkers. measurement example, categorize targeted before administrating aiming obtaining better efficacy.