Identification of cardiovascular and molecular prognostic factors for the morbidity and mortality in COVID-19-sepsis (ICROVID): Protocol for a prospective multi-centre cohort study

• Published in: PloS one Vol. 17; no. 6; p. e0269247
• Main Authors: Neu, Charles, Baumbach, Philipp, Scherag, André, Kortgen, Andreas, Götze, Juliane, Coldewey, Sina M
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 03-06-2022; Public Library of Science (PLoS)
• Subjects: Biology and Life Sciences; Cardiac function; Cardiomyopathy; Cardiovascular diseases; Care and treatment; Clinical trials; Cohort analysis; Coronaviruses; COVID-19; Diagnosis; Disease; Echocardiography; Ejection fraction; Embolism; Ethics; Genotype & phenotype; Health risks; Hospitals; Immune status; Infections; Influenza; Intensive care; Laboratories; Laboratory tests; Medical prognosis; Medicine and Health Sciences; Morbidity; Mortality; Multiple organ failure; Myocarditis; Pandemics; Patients; Phenotyping; Prevention; Public health; Pulmonary embolism; Research and Analysis Methods; Risk analysis; Risk factors; Sepsis; Severe acute respiratory syndrome coronavirus 2; Study Protocol; Viruses; Germany
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0269247

Severe COVID-19 constitutes a form of viral sepsis. Part of the specific pathophysiological pattern of this condition is the occurrence of cardiovascular events. These include pulmonary embolism, arrhythmias and cardiomyopathy as manifestations of extra-pulmonary organ dysfunction. Hitherto, the prognostic impact of these cardiovascular events and their predisposing risk factors remains unclear. This study aims to explore this question in two cohorts of viral sepsis-COVID-19 and influenza-in order to identify new theragnostic strategies to improve the short- and long-term outcome of these two diseases.
In this prospective multi-centre cohort study, clinical assessment will take place during the acute and post-acute phase of sepsis and be complemented by molecular laboratory analyses. Specifically, echocardiography and cardiovascular risk factor documentation will be performed during the first two weeks after sepsis onset. Aside from routine haematological and biochemical laboratory tests, molecular phenotyping will comprise analyses of the metabolome, lipidome and immune status. The primary endpoint of this study is the difference in 3-month mortality of patients with and without septic cardiomyopathy in COVID-19 sepsis. Patients will be followed up until 6 months after onset of sepsis via telephone interviews and questionnaires. The results will be compared with a cohort of patients with influenza sepsis as well as previous cohorts of patients with bacterial sepsis and healthy controls.
Approval was obtained from the Ethics Committee of the Friedrich Schiller University Jena (2020-2052-BO). The results will be published in peer-reviewed journals and presented at appropriate conferences.
DRKS00024162.