Please use this identifier to cite or link to this item: https://doi.org/10.1136/bmjopen-2020-044497
Title: Prospective validation study of prognostic biomarkers to predict adverse outcomes in patients with COVID-19: a study protocol
Authors: Tang, Benjamin
Shojaei, 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 PJ
Cox, Amanda J
West, Nicholas P
Cripps, Allan William
Schughart, Klaus
Maria, Andrea de
Chaussabel, Damien
Iredell, Jonathan
Weng, Stephen
Issue Date: 6-Jan-2021
Publisher: BMJ
Citation: Tang, Benjamin, Shojaei, 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 PJ, Cox, Amanda J, West, Nicholas P, Cripps, Allan William, Schughart, Klaus, Maria, Andrea de, Chaussabel, Damien, Iredell, Jonathan, Weng, Stephen (2021-01-06). Prospective validation study of prognostic biomarkers to predict adverse outcomes in patients with COVID-19: a study protocol. BMJ Open 11 (1) : e044497. ScholarBank@NUS Repository. https://doi.org/10.1136/bmjopen-2020-044497
Abstract: 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
Source Title: BMJ Open
URI: https://scholarbank.nus.edu.sg/handle/10635/185423
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2020-044497
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