Prospective validation study of prognostic biomarkers to predict adverse outcomes in patients with COVID-19: a study protocol.
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Authors
Tang, BenjaminShojaei, Maryam
Wang, Ya
Nalos, Marek
McLean, Anthony
Afrasiabi, Ali
Kwan, Tim N
Kuan, Win Sen
Zerbib, Yoann
Herwanto, Velma
Gunawan, Gunawan
Bedognetti, Davide
Zoppoli, Gabriele
Ballestrero, Alberto
Rinchai, Darawan
Cremonesi, Paolo
Bedognetti, Michele
Matejovic, Martin
Karvunidis, Thomas
Macdonald, Stephen P J
Cox, Amanda J
West, Nicholas P
Cripps, Allan William
Schughart, Klaus
Maria, Andrea de
Chaussabel, Damien
Iredell, Jonathan
Weng, Stephen
Issue Date
2021-01-06
Metadata
Show full item recordAbstract
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.Citation
BMJ Open. 2021 Jan 6;11(1):e044497. doi: 10.1136/bmjopen-2020-044497.Affiliation
HZI,Helmholtz-Zentrum für Infektionsforschung GmbH, Inhoffenstr. 7,38124 Braunschweig, Germany.Publisher
BMJ publishing groupJournal
BMJ openPubMed ID
33408218Type
ArticleLanguage
enEISSN
2044-6055ae974a485f413a2113503eed53cd6c53
10.1136/bmjopen-2020-044497
Scopus Count
The following license files are associated with this item:
- Creative Commons
Except where otherwise noted, this item's license is described as Attribution-ShareAlike 4.0 International
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