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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.authorCox, Amanda J
dc.contributor.authorWest, Nicholas P
dc.contributor.authorCripps, Allan William
dc.contributor.authoret al.
dc.date.accessioned2021-01-13T05:49:23Z
dc.date.available2021-01-13T05:49:23Z
dc.date.issued2021
dc.identifier.issn2044-6055
dc.identifier.doi10.1136/bmjopen-2020-044497
dc.identifier.urihttp://hdl.handle.net/10072/401008
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.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherBMJ
dc.relation.ispartofpagefrome044497
dc.relation.ispartofissue1
dc.relation.ispartofjournalBMJ Open
dc.relation.ispartofvolume11
dc.subject.fieldofresearchClinical Sciences
dc.subject.fieldofresearchPublic Health and Health Services
dc.subject.fieldofresearchOther Medical and Health Sciences
dc.subject.fieldofresearchcode1103
dc.subject.fieldofresearchcode1117
dc.subject.fieldofresearchcode1199
dc.subject.keywordsCOVID-19
dc.subject.keywordsadult intensive & critical care
dc.subject.keywordsimmunology
dc.subject.keywordsmolecular diagnostics
dc.titleProspective validation study of prognostic biomarkers to predict adverse outcomes in patients with COVID-19: a study protocol
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationTang, B; Shojaei, M; Wang, Y; Nalos, M; Mclean, A; Afrasiabi, A; Kwan, TN; Kuan, WS; Zerbib, Y; Herwanto, V; Gunawan, G; Cox, AJ; West, NP; Cripps, AW; et al., PREDICT-19 consortium, Prospective validation study of prognostic biomarkers to predict adverse outcomes in patients with COVID-19: a study protocol, BMJ Open, 2021, 11 (1), pp. e044497
dcterms.licensehttp://creativecommons.org/licenses/by-nc/4.0/
dc.date.updated2021-01-13T05:08:01Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© Author(s) (or their employer(s)) 2021. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
gro.hasfulltextFull Text
gro.griffith.authorCripps, Allan W.
gro.griffith.authorCox, Amanda J.
gro.griffith.authorWest, Nic P.


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