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Prospective validation study of prognostic biomarkers to predict adverse outcomes in patients with COVID-19: a study protocol

B. Tang, M. Shojaei, Y. Wang, M. Nalos, A. Mclean, A. Afrasiabi, TN. Kwan, WS. Kuan, Y. Zerbib, V. Herwanto, G. Gunawan, D. Bedognetti, G. Zoppoli, A. Ballestrero, D. Rinchai, P. Cremonesi, M. Bedognetti, M. Matejovic, T. Karvunidis, SPJ....

. 2021 ; 11 (1) : e044497. [pub] 20210106

Language English Country Great Britain

Document type Journal Article, Research Support, Non-U.S. Gov't, Validation Study

Persistent link   https://www.medvik.cz/link/bmc21011624

INTRODUCTION: Accurate triage is an important first step to effectively manage the clinical treatment of severe cases in a pandemic outbreak. In the current COVID-19 global pandemic, there is a lack of reliable clinical tools to assist clinicians to perform accurate triage. Host response biomarkers have recently shown promise in risk stratification of disease progression; however, the role of these biomarkers in predicting disease progression in patients with COVID-19 is unknown. Here, we present a protocol outlining a prospective validation study to evaluate the biomarkers' performance in predicting clinical outcomes of patients with COVID-19. METHODS AND ANALYSIS: This prospective validation study assesses patients infected with COVID-19, in whom blood samples are prospectively collected. Recruited patients include a range of infection severity from asymptomatic to critically ill patients, recruited from the community, outpatient clinics, emergency departments and hospitals. Study samples consist of peripheral blood samples collected into RNA-preserving (PAXgene/Tempus) tubes on patient presentation or immediately on study enrolment. Real-time PCR (RT-PCR) will be performed on total RNA extracted from collected blood samples using primers specific to host response gene expression biomarkers that have been previously identified in studies of respiratory viral infections. The RT-PCR data will be analysed to assess the diagnostic performance of individual biomarkers in predicting COVID-19-related outcomes, such as viral pneumonia, acute respiratory distress syndrome or bacterial pneumonia. Biomarker performance will be evaluated using sensitivity, specificity, positive and negative predictive values, likelihood ratios and area under the receiver operating characteristic curve. ETHICS AND DISSEMINATION: This research protocol aims to study the host response gene expression biomarkers in severe respiratory viral infections with a pandemic potential (COVID-19). It has been approved by the local ethics committee with approval number 2020/ETH00886. The results of this project will be disseminated in international peer-reviewed scientific journals.

1st Medical Department Faculty of Medicine in Pilsen Charles University Medical School and Teaching Hospital Plzen Pilsen Czech Republic

Azienda Sanitaria Locale 3 Genovese Genova Liguria Italy

Cancer Research Department Sidra Medicine Doha Qatar

Centre for Clinical Research in Emergency Medicine Royal Perth Hospital Perth Western Australia Australia

Centre for Immunology and Allergy Research Westmead Institute for Medical Research Westmead New South Wales Australia

Centre for Infectious Diseases and Microbiology Westmead Hospital Westmead New South Wales Australia

Department of Health Sciences University of Genoa Genova Liguria Italy

Department of Infection Genetics Helmholtz Centre for Infection Research Braunschweig Niedersachsen Germany

Department of Intensive Care Medicine Amiens University Hospital Amiens France

Department of Internal Medicine Medistra Hospital Jakarta Indonesia

Department of Internal Medicine University of Genoa Genova Italy

Department of Surgery National University Singapore Yong Loo Lin School of Medicine Singapore

Division of Infectious and Tropical Diseases IRCCS Ospedale Policlinico San Martino Genova Liguria Italy

Division of Internal Medicine and Oncology IRCCS Ospedale Policlinico San Martino Genova Italy

Division of Primary Care University of Nottingham Nottingham UK

Emergency Medicine National University Hospital Singapore

Ente Ospedaliero Ospedali Galliera Genova Liguria Italy

Immunology Department Sidra Medical and Research Center Doha Ad Dawhah Qatar

Mucosal Immunology Research Group Griffith University Menzies Health Institute Queensland Southport Queensland Australia

Nepean Clinical School University of Sydney Sydney New South Wales Australia

System Biology and Health Data Analytic Lab The Graduate School of Biomedical Engineering University of New South Wales Sydney New South Wales Australia

Tarumanagara University Faculty of Medicine Jakarta Barat Jakarta Indonesia

University of Veterinary Medicine Hannover Hannover Niedersachsen Germany

Westmead Institute for Medical Research Westmead New South Wales Australia

References provided by Crossref.org

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