Molecular and Cellular Biomarkers of COVID-19 Prognosis: Protocol for the Prospective Cohort TARGET Study

Abstract

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Since the beginning of the COVID-19 pandemic, the world’s attention has been focused on better understanding the relations between the human host and the SARS-CoV-2 virus, as its action has led to hundreds of thousands of deaths. Objective: In this context, we decided to study certain consequences of the abundant cytokine release over the innate and adaptive immune systems, inflammation and haemostasis, comparing mild and severe forms of COVID-19. Objective: : In this context, we decided to study certain consequences of the abundant cytokine release over the innate and adaptive immune systems, inflammation and haemostasis, comparing mild and severe forms of COVID-19. Methods: To accomplish these aims, we will analyse demographic characteristics, biochemical tests, immune biomarkers, leukocyte phenotyping, immunoglobulin profile, hormonal release (cortisol and prolactin), gene expression, thromboelastometry, neutralizing antibodies, metabolic profile and neutrophil function (ROS and NET production, phagocytosis, migration, gene expression and proteomics). Two hundred RT-PCR confirmed patients will be enrolled and divided into two groups: mild/moderate or severe/critical forms of COVID-19. Blood samples will be collected at different times: at inclusion and after 9 and 18 days, with an additional 3-day sample for severe patients. Results: This protocol is in the data collection phase. Study recruitment started in June 2020. Until the end of July 2020, 30 T-branch and 85 D-branch patients were enrolled. Data analysis is scheduled to start after all inclusion data have been collected. Conclusions: We believe that this information will provide more knowledge for ensuing studies that will provide more robust and useful clinical information that may allow for better decisions at the frontlines of health assistance. Clinical Trial: RBR-62zdkk