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Prospective validation study of prognostic biomarkers to predict adverse outcomes in patients with COVID-19: a study protocol.
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 P J; Cox, Amanda J; West, Nicholas P; Cripps, Allan William; Schughart, Klaus; Maria, Andrea de; Chaussabel, Damien; Iredell, Jonathan; Weng, Stephen.
  • Tang B; Nepean Clinical School, University of Sydney, Sydney, New South Wales, Australia benjamin.tang@sydney.edu.au.
  • Shojaei M; Centre for Immunology and Allergy Research, Westmead Institute for Medical Research, Westmead, New South Wales, Australia.
  • Wang Y; Nepean Clinical School, University of Sydney, Sydney, New South Wales, Australia.
  • Nalos M; Westmead Institute for Medical Research, Westmead, New South Wales, Australia.
  • Mclean A; Nepean Clinical School, University of Sydney, Sydney, New South Wales, Australia.
  • Afrasiabi A; Centre for Immunology and Allergy Research, Westmead Institute for Medical Research, Westmead, New South Wales, Australia.
  • Kwan TN; Nepean Clinical School, University of Sydney, Sydney, New South Wales, Australia.
  • Kuan WS; Nepean Clinical School, University of Sydney, Sydney, New South Wales, Australia.
  • Zerbib Y; Centre for Immunology and Allergy Research, Westmead Institute for Medical Research, Westmead, New South Wales, Australia.
  • Herwanto V; System Biology and Health Data Analytic Lab, The Graduate School of Biomedical Engineering, University of New South Wales, Sydney, New South Wales, Australia.
  • Gunawan G; Nepean Clinical School, University of Sydney, Sydney, New South Wales, Australia.
  • Bedognetti D; Emergency Medicine, National University Hospital, Singapore.
  • Zoppoli G; Department of Surgery, National University Singapore Yong Loo Lin School of Medicine, Singapore.
  • Ballestrero A; Department of Intensive Care Medicine, Amiens University Hospital, Amiens, France.
  • Rinchai D; Centre for Immunology and Allergy Research, Westmead Institute for Medical Research, Westmead, New South Wales, Australia.
  • Cremonesi P; Tarumanagara University Faculty of Medicine, Jakarta Barat, Jakarta, Indonesia.
  • Bedognetti M; Department of Internal Medicine, Medistra Hospital, Jakarta, Indonesia.
  • Matejovic M; Cancer Research Department, Sidra Medicine, Doha, Qatar.
  • Karvunidis T; Department of Internal Medicine, University of Genoa, Genova, Italy.
  • Macdonald SPJ; Department of Internal Medicine, University of Genoa, Genova, Italy.
  • Cox AJ; Division of Internal Medicine and Oncology, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
  • West NP; Department of Internal Medicine, University of Genoa, Genova, Italy.
  • Cripps AW; Division of Internal Medicine and Oncology, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
  • Schughart K; Cancer Research Department, Sidra Medicine, Doha, Qatar.
  • Maria A; Ente Ospedaliero Ospedali Galliera, Genova, Liguria, Italy.
  • Chaussabel D; Azienda Sanitaria Locale 3 Genovese, Genova, Liguria, Italy.
  • Iredell J; First Medical Department, Faculty of Medicine in Pilsen, Charles University Medical School and Teaching Hospital Plzen, Pilsen, Czech Republic.
  • Weng S; First Medical Department, Faculty of Medicine in Pilsen, Charles University Medical School and Teaching Hospital Plzen, Pilsen, Czech Republic.
BMJ Open ; 11(1): e044497, 2021 01 06.
Article in English | MEDLINE | ID: covidwho-1013055
Semantic information from SemMedBD (by NLM)
1. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
2. Triage ADMINISTERED_TO Clinician
Subject
Triage
Predicate
ADMINISTERED_TO
Object
Clinician
3. Disease Progression PROCESS_OF Patients
Subject
Disease Progression
Predicate
PROCESS_OF
Object
Patients
4. COVID-19 PREDISPOSES Disease Progression
Subject
COVID-19
Predicate
PREDISPOSES
Object
Disease Progression
5. Critical Illness PROCESS_OF Patients
Subject
Critical Illness
Predicate
PROCESS_OF
Object
Patients
6. Biological Markers PREDISPOSES COVID-19
Subject
Biological Markers
Predicate
PREDISPOSES
Object
COVID-19
7. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
8. Triage ADMINISTERED_TO Clinician
Subject
Triage
Predicate
ADMINISTERED_TO
Object
Clinician
9. Disease Progression PROCESS_OF Patients
Subject
Disease Progression
Predicate
PROCESS_OF
Object
Patients
10. COVID-19 PREDISPOSES Disease Progression
Subject
COVID-19
Predicate
PREDISPOSES
Object
Disease Progression
11. Critical Illness PROCESS_OF Patients
Subject
Critical Illness
Predicate
PROCESS_OF
Object
Patients
12. Biological Markers PREDISPOSES COVID-19
Subject
Biological Markers
Predicate
PREDISPOSES
Object
COVID-19
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 ethics committee with approval number 2020/ETH00886. The results of this project will be disseminated in international peer-reviewed scientific journals.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Biomarkers / Triage / Critical Illness / Emergency Service, Hospital / Pandemics / SARS-CoV-2 / COVID-19 Type of study: Clinical Practice Guide / Observational study / Prognostic study / Risk factors Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2020-044497

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Biomarkers / Triage / Critical Illness / Emergency Service, Hospital / Pandemics / SARS-CoV-2 / COVID-19 Type of study: Clinical Practice Guide / Observational study / Prognostic study / Risk factors Limits: Adult / Female / Humans / Male / Middle aged Language: English Journal: BMJ Open Year: 2021 Document Type: Article Affiliation country: Bmjopen-2020-044497