Derivation and Validation of a Predictive Score for Disease Worsening in Patients with COVID-19

Abstract

The prospective observational cohort study COMPASS-COVID-19 aimed to develop a risk assessment model for early identification of hospitalized COVID-19 patients at risk for worsening disease. Patients with confirmed COVID-19 (n = 430) hospitalized between March 18 and April 21, 2020 were divided in derivation (n = 310) and validation (n = 120) cohorts. Two groups became evident: (1) good prognosis group (G-group) with patients hospitalized at the conventional COVID-19 ward and (2) Worsening disease group (W-group) with patients admitted to the intensive care unit (ICU) from the emergency departments. The study end point was disease worsening (acute respiratory failure, shock, myocardial dysfunction, bacterial or viral coinfections, and acute kidney injury) requiring ICU admission. All patients were routinely evaluated for full blood count, prothrombin time, fibrinogen, D-dimers, antithrombin (AT), 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 routinely registered. Obesity, hypertension, diabetes and male gender, increased fibrinogen and D-dimers, thrombocytopenia, AT deficiency, lymphopenia, and an International Society on Thrombosis and Haemostasis (ISTH) score for compensated disseminated intravascular coagulation score (cDIC-ISTH) ≥5 were significant risk factors for worsening disease. The COMPASS-COVID-19 score was derived from multivariate analyses and includes obesity, gender, hemoglobin, lymphocyte, and the cDIC-ISTH score (including platelet count, prothrombin time, D-dimers, AT, and protein C levels). The score has a very good discriminating capacity to stratify patients at high and low risk for worsening disease, with an area under the receiver operating characteristic curve value of 0.77, a sensitivity of 81%, and a specificity of 60%. Application of the COMPASS-COVID-19 score at the validation cohort showed 96% sensitivity. The COMPASS-COVID-19 score is an accurate clinical decision-making tool for an easy identification of COVID-19 patients being at high risk for disease worsening. After approval from the legal authorities of the Assistance Publique-Hôpitaux de Paris (APHP), data can be shared—after contacting the corresponding author (grigorios.gerotziafas@inserm.fr)—with qualifying researchers who submit a proposal with a valuable research question. A contract should be signed. G.T.G. as principal investigator has made substantial contributions to the conception and design of the study and analysis and interpretation of the data, wrote the manuscript and has given the final approval of the version to be published, agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. T.N.S. has made substantial contribution by doing the statistical plan and the statistical analysis. G.V. has made substantial contribution in the enrolment of the patients and participated in the design of the study. L.L. has made substantial contribution in the enrolment of the patients. C.P. has made substantial contribution in data acquisition, data interpretation, and critical revision of the manuscript. A.E. participated in the enrollment of the patients and data acquisition. M.T. participated in the enrollment of the patients and data acquisition. P.V. participated in the critical revision and editing of the manuscript. L.P. participated in the critical revision and editing of the manuscript. T.P. participated in the statistical analysis. E.T. critically revised the manuscript. M-.A.D. gave valuable suggestions for data analysis and critically revised the manuscript. A.P., J.C., and G.P. have made substantial contribution in the enrollment of the patients and critically revised the manuscript. M.F. made substantial contribution to the design of the study, the interpretation of the data, and critically revised the manuscript. I.E. critically revised the manuscript. Received: 18 May 2020 Accepted: 13 August 2020 Publication Date: 22 September 2020 (online) Georg Thieme Verlag KG Stuttgart · New York