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

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

chronic airways disease, COVID-19, health informatics, protocols & guidelines, respiratory infections, respiratory medicine (see thoracic medicine)
2044-6055
e043012
Burke, Hannah
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Freeman, Anna
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Dushianthan, Ahilanandan
013692a2-cf26-4278-80bd-9d8fcdb17751
Celinski, Michael
f5ddadb6-e935-476c-ab46-0423a031a83b
Batchelor, James
e53c36c7-aa7f-4fae-8113-30bfbb9b36ee
Phan, Hang
2811b94c-62b7-459d-9cc1-c88057008e3b
Borca, Florina
31fc3965-6bcf-4fd6-85bc-8b0f99f62473
Kipps, Christopher
e43be016-2dc2-45e6-9a02-ab2a0e0208d5
Thomas, Gareth J.
2ff54aa9-a766-416b-91ee-cf1c5be74106
Faust, Saul N.
f97df780-9f9b-418e-b349-7adf63e150c1
Sheard, Natasha
03c5f465-4f23-4dbd-a1b3-46a95acb5ac8
Williams, Sarah
3799b145-26c0-4324-b414-32c2c5ab88fa
Fitzpatrick, Paul
c69e3599-05cb-4e91-ba79-b71c61e970c2
Landers, Dónal
497637aa-531d-40ce-9a4d-e724226a8aa9
Wilkinson, Tom
8c55ebbb-e547-445c-95a1-c8bed02dd652
Burke, Hannah
a9bb9391-4704-4584-aeb7-e69fe0acbdb8
Freeman, Anna
3d83f907-e7ce-4649-a018-a7a31b19f934
Dushianthan, Ahilanandan
013692a2-cf26-4278-80bd-9d8fcdb17751
Celinski, Michael
f5ddadb6-e935-476c-ab46-0423a031a83b
Batchelor, James
e53c36c7-aa7f-4fae-8113-30bfbb9b36ee
Phan, Hang
2811b94c-62b7-459d-9cc1-c88057008e3b
Borca, Florina
31fc3965-6bcf-4fd6-85bc-8b0f99f62473
Kipps, Christopher
e43be016-2dc2-45e6-9a02-ab2a0e0208d5
Thomas, Gareth J.
2ff54aa9-a766-416b-91ee-cf1c5be74106
Faust, Saul N.
f97df780-9f9b-418e-b349-7adf63e150c1
Sheard, Natasha
03c5f465-4f23-4dbd-a1b3-46a95acb5ac8
Williams, Sarah
3799b145-26c0-4324-b414-32c2c5ab88fa
Fitzpatrick, Paul
c69e3599-05cb-4e91-ba79-b71c61e970c2
Landers, Dónal
497637aa-531d-40ce-9a4d-e724226a8aa9
Wilkinson, Tom
8c55ebbb-e547-445c-95a1-c8bed02dd652

Burke, Hannah, Freeman, Anna, Dushianthan, Ahilanandan, Celinski, Michael, Batchelor, James, Phan, Hang, Borca, Florina, Kipps, Christopher, Thomas, Gareth J., Faust, Saul N., Sheard, Natasha, Williams, Sarah, Fitzpatrick, Paul, Landers, Dónal and Wilkinson, Tom (2021) Research Evaluation Alongside Clinical Treatment in COVID-19 (REACT COVID-19): An observational and biobanking study. BMJ Open, 11 (1), e043012, [e043012]. (doi:10.1136/bmjopen-2020-043012).

Record type: Article

Abstract

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.

This record has no associated files available for download.

More information

Accepted/In Press date: 2 January 2021
Published date: 22 January 2021
Keywords: chronic airways disease, COVID-19, health informatics, protocols & guidelines, respiratory infections, respiratory medicine (see thoracic medicine)

Identifiers

Local EPrints ID: 447403
URI: http://eprints.soton.ac.uk/id/eprint/447403
ISSN: 2044-6055
PURE UUID: 5ebba226-6d2f-40d8-bcc1-74c1342a4d3a
ORCID for Ahilanandan Dushianthan: ORCID iD orcid.org/0000-0002-0165-3359
ORCID for James Batchelor: ORCID iD orcid.org/0000-0002-5307-552X
ORCID for Saul N. Faust: ORCID iD orcid.org/0000-0003-3410-7642

Catalogue record

Date deposited: 10 Mar 2021 17:43
Last modified: 26 Nov 2021 03:15

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Contributors

Author: Hannah Burke
Author: Anna Freeman
Author: Ahilanandan Dushianthan ORCID iD
Author: Michael Celinski
Author: James Batchelor ORCID iD
Author: Hang Phan
Author: Florina Borca
Author: Christopher Kipps
Author: Saul N. Faust ORCID iD
Author: Natasha Sheard
Author: Sarah Williams
Author: Paul Fitzpatrick
Author: Dónal Landers
Author: Tom Wilkinson

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