Derivation and Validation of a Predictive Score for Disease Worsening in Patients with COVID-19: The COMPASS-COVID-19 Prospective Observational Cohort Study

Background: Identification of COVID-19 patients at high risk for clinical deterioration is a challenge for prompt management and positive clinical outcome. The prospective observational study aimed to develop a risk assessment model (RAM) for early identification of COVID-19 patients at risk for worsening disease. Methods: Patients with confirmed COVID-19 (n=430) were divided in derivation (n=310) and validation (n=120) cohorts and stratified to those hospitalized at the conventional ward (C-group) and those with worsening disease (W-group) admitted in Intensive Care Unit (ICU). The study end point was disease worsening. All patients were routinely evaluated with full blood count, prothrombin time, fibrinogen, D-Dimers, antithrombin and protein C activity. Data from the first hospitalization day at the conventional ward or the ICU were analyzed. Cardiovascular risk factors and comorbidities were routinelly registered. Findings: Obesity, hypertension, diabetes and male gender, increased fibrinogen and D-Dimers, thrombocytopenia, AT-deficiency, lymphopenia and compensated DIC-ISTH score ≥ 5 were significant independent risk factors for worsening disease. The COMPASS-COVID-19 score derived from multivariate analysis includes obesity, gender, compensated DIC, hemoglobin, and lymphocyte count. The score has a very good discriminating capacity to stratify patients at high and low risk for worsening disease, with AUC value at 0.77, sensitivity 81% and specificity 60%. Application of the COMPASS-COVID-19 score at the validation cohort showed 96% sensitivity and 45% specificity. Interpretation: The COMPASS-COVID-19 score could serve as an accurate clinical decision tool for an easy identification of COVID-19 patients being at high risk for disease worsening leading to prompt application of compassionate treatments including antithrombotic agents. Funding Statement: None. Declaration of Interests: The authors have no conflict of interest to declare. Ethics Approval Statement: The protocol of the study was in accordance with the commitment of the Helsinki declaration and all patients received healthcare according to the recommended institutional practice during COVID-19 pandemic. All hematological tests were performed in the frame of routine monitoring of patients as decided by the local institutional board for the management of the COVID-19 patients.