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dc.contributor.authorTang, Benjamin
dc.contributor.authorShojaei, Maryam
dc.contributor.authorWang, Ya
dc.contributor.authorNalos, Marek
dc.contributor.authorMcLean, Anthony
dc.contributor.authorAfrasiabi, Ali
dc.contributor.authorKwan, Tim N
dc.contributor.authorKuan, Win Sen
dc.contributor.authorZerbib, Yoann
dc.contributor.authorHerwanto, Velma
dc.contributor.authorGunawan, Gunawan
dc.contributor.authorBedognetti, Davide
dc.contributor.authorZoppoli, Gabriele
dc.contributor.authorBallestrero, Alberto
dc.contributor.authorRinchai, Darawan
dc.contributor.authorCremonesi, Paolo
dc.contributor.authorBedognetti, Michele
dc.contributor.authorMatejovic, Martin
dc.contributor.authorKarvunidis, Thomas
dc.contributor.authorMacdonald, Stephen P J
dc.contributor.authorCox, Amanda J
dc.contributor.authorWest, Nicholas P
dc.contributor.authorCripps, Allan William
dc.contributor.authorSchughart, Klaus
dc.contributor.authorMaria, Andrea de
dc.contributor.authorChaussabel, Damien
dc.contributor.authorIredell, Jonathan
dc.contributor.authorWeng, Stephen
dc.identifier.citationBMJ Open. 2021 Jan 6;11(1):e044497. doi: 10.1136/bmjopen-2020-044497.en_US
dc.description.abstractIntroduction: 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.en_US
dc.publisherBMJ publishing groupen_US
dc.rightsAttribution-ShareAlike 4.0 International*
dc.subjectadult intensive & critical careen_US
dc.subjectmolecular diagnosticsen_US
dc.titleProspective validation study of prognostic biomarkers to predict adverse outcomes in patients with COVID-19: a study protocol.en_US
dc.contributor.departmentHZI,Helmholtz-Zentrum für Infektionsforschung GmbH, Inhoffenstr. 7,38124 Braunschweig, Germany.en_US
dc.identifier.journalBMJ openen_US
dc.source.journaltitleBMJ open

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