Research Evaluation Alongside Clinical Treatment in COVID-19 (REACT COVID-19): an observational and biobanking study

Introduction The COVID-19 pandemic caused by SARS-CoV-2 places immense worldwide demand on healthcare services. Earlier identification of patients at risk of severe disease may allow intervention with experimental targeted treatments, mitigating the course of their disease and reducing critical care...

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Autores principales: Gareth J Thomas, Saul N Faust, Christopher Kipps, Hang Phan, Florina Borca, Sarah Williams, Tom Wilkinson, Hannah Burke, Anna Freeman, Ahilanandan Dushianthan, Michael Celinski, James Batchelor, Natasha Sheard, Paul Fitzpatrick, Dónal Landers
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spelling oai:doaj.org-article:912650ad59864fc49299b66d495a79db2021-11-18T17:00:08ZResearch Evaluation Alongside Clinical Treatment in COVID-19 (REACT COVID-19): an observational and biobanking study10.1136/bmjopen-2020-0430122044-6055https://doaj.org/article/912650ad59864fc49299b66d495a79db2021-01-01T00:00:00Zhttps://bmjopen.bmj.com/content/11/1/e043012.fullhttps://doaj.org/toc/2044-6055Introduction The COVID-19 pandemic caused by SARS-CoV-2 places immense worldwide demand on healthcare services. Earlier identification of patients at risk of severe disease may allow intervention with experimental targeted treatments, mitigating the course of their disease and reducing critical care service demand.Methods and analysis This prospective observational study of patients tested or treated for SARS-CoV-2, who are under the care of the tertiary University Hospital Southampton NHS Foundation Trust (UHSFT), captured data from admission to discharge; data collection commenced on 7 March 2020. Core demographic and clinical information, as well as results of disease-defining characteristics, was captured and recorded electronically from hospital clinical record systems at the point of testing. Manual data were collected and recorded by the clinical research team for assessments which are not part of the structured electronic healthcare record, for example, symptom onset date. Thereafter, participant records were continuously updated during hospital stay and their follow-up period. Participants aged >16 years were given the opportunity to provide consent for excess clinical sample storage with optional further biological sampling. These anonymised samples were linked to the clinical data in the Real-time Analytics for Clinical Trials platform and were stored within a biorepository at UHSFT.Ethics and dissemination Ethical approval was obtained from the HRA Specific Review Board (REC 20/HRA/2986) for waiver of informed consent for the database-only cohort; the procedures conform with the Declaration of Helsinki. The study design, protocol and patient-facing documentation for the biobanking arm of the study have been approved by North West Research Ethics Committee (REC 17/NW/0632) as an amendment to the National Institute for Health Research Southampton Clinical Research Facility-managed Southampton Research Biorepository. This study will be published as peer-reviewed articles and presented at conferences, presentations and workshops.Gareth J ThomasSaul N FaustChristopher KippsHang PhanFlorina BorcaSarah WilliamsTom WilkinsonHannah BurkeAnna FreemanAhilanandan DushianthanMichael CelinskiJames BatchelorNatasha SheardPaul FitzpatrickDónal LandersBMJ Publishing GrouparticleMedicineRENBMJ Open, Vol 11, Iss 1 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
spellingShingle Medicine
R
Gareth J Thomas
Saul N Faust
Christopher Kipps
Hang Phan
Florina Borca
Sarah Williams
Tom Wilkinson
Hannah Burke
Anna Freeman
Ahilanandan Dushianthan
Michael Celinski
James Batchelor
Natasha Sheard
Paul Fitzpatrick
Dónal Landers
Research Evaluation Alongside Clinical Treatment in COVID-19 (REACT COVID-19): an observational and biobanking study
description Introduction The COVID-19 pandemic caused by SARS-CoV-2 places immense worldwide demand on healthcare services. Earlier identification of patients at risk of severe disease may allow intervention with experimental targeted treatments, mitigating the course of their disease and reducing critical care service demand.Methods and analysis This prospective observational study of patients tested or treated for SARS-CoV-2, who are under the care of the tertiary University Hospital Southampton NHS Foundation Trust (UHSFT), captured data from admission to discharge; data collection commenced on 7 March 2020. Core demographic and clinical information, as well as results of disease-defining characteristics, was captured and recorded electronically from hospital clinical record systems at the point of testing. Manual data were collected and recorded by the clinical research team for assessments which are not part of the structured electronic healthcare record, for example, symptom onset date. Thereafter, participant records were continuously updated during hospital stay and their follow-up period. Participants aged >16 years were given the opportunity to provide consent for excess clinical sample storage with optional further biological sampling. These anonymised samples were linked to the clinical data in the Real-time Analytics for Clinical Trials platform and were stored within a biorepository at UHSFT.Ethics and dissemination Ethical approval was obtained from the HRA Specific Review Board (REC 20/HRA/2986) for waiver of informed consent for the database-only cohort; the procedures conform with the Declaration of Helsinki. The study design, protocol and patient-facing documentation for the biobanking arm of the study have been approved by North West Research Ethics Committee (REC 17/NW/0632) as an amendment to the National Institute for Health Research Southampton Clinical Research Facility-managed Southampton Research Biorepository. This study will be published as peer-reviewed articles and presented at conferences, presentations and workshops.
format article
author Gareth J Thomas
Saul N Faust
Christopher Kipps
Hang Phan
Florina Borca
Sarah Williams
Tom Wilkinson
Hannah Burke
Anna Freeman
Ahilanandan Dushianthan
Michael Celinski
James Batchelor
Natasha Sheard
Paul Fitzpatrick
Dónal Landers
author_facet Gareth J Thomas
Saul N Faust
Christopher Kipps
Hang Phan
Florina Borca
Sarah Williams
Tom Wilkinson
Hannah Burke
Anna Freeman
Ahilanandan Dushianthan
Michael Celinski
James Batchelor
Natasha Sheard
Paul Fitzpatrick
Dónal Landers
author_sort Gareth J Thomas
title Research Evaluation Alongside Clinical Treatment in COVID-19 (REACT COVID-19): an observational and biobanking study
title_short Research Evaluation Alongside Clinical Treatment in COVID-19 (REACT COVID-19): an observational and biobanking study
title_full Research Evaluation Alongside Clinical Treatment in COVID-19 (REACT COVID-19): an observational and biobanking study
title_fullStr Research Evaluation Alongside Clinical Treatment in COVID-19 (REACT COVID-19): an observational and biobanking study
title_full_unstemmed Research Evaluation Alongside Clinical Treatment in COVID-19 (REACT COVID-19): an observational and biobanking study
title_sort research evaluation alongside clinical treatment in covid-19 (react covid-19): an observational and biobanking study
publisher BMJ Publishing Group
publishDate 2021
url https://doaj.org/article/912650ad59864fc49299b66d495a79db
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