Protocol for the COG-UK hospital-onset COVID-19 infection (HOCI) multicentre interventional clinical study: evaluating the efficacy of rapid genome sequencing of SARS-CoV-2 in limiting the spread of COVID-19 in UK NHS hospitals

Blackstone, James, Stirrup, Oliver, Mapp, Fiona, Panca, Monica, Copas, Andrew, Flowers, Paul, Hockey, Leanne, Price, James, Partridge, David, Peters, Christine, de Silva, Thushan, Nebbia, Gaia, Snell, Luke B, McComish, Rachel, Breuer, Judith, The COVID-19 Genomics UK (COG-UK) Consortium, , Bashton, Matthew, McCann, Clare, Nelson, Andrew, Smith, Darren and Young, Greg (2022) Protocol for the COG-UK hospital-onset COVID-19 infection (HOCI) multicentre interventional clinical study: evaluating the efficacy of rapid genome sequencing of SARS-CoV-2 in limiting the spread of COVID-19 in UK NHS hospitals. BMJ Open, 12 (4). e052514. ISSN 2044-6055

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Official URL: https://doi.org/10.1136/bmjopen-2021-052514

Abstract

Objectives: Nosocomial transmission of SARS-CoV-2 has been a significant cause of mortality in National Health Service (NHS) hospitals during the COVID-19 pandemic. The COG-UK Consortium Hospital-Onset COVID-19 Infections (COG-UK HOCI) study aims to evaluate whether the use of rapid whole-genome sequencing of SARS-CoV-2, supported by a novel probabilistic reporting methodology, can inform infection prevention and control (IPC) practice within NHS hospital settings. Design: Multicentre, prospective, interventional, superiority study. Setting: 14 participating NHS hospitals over winter-spring 2020/2021 in the UK. Participants: Eligible patients must be admitted to hospital with first-confirmed SARS-CoV-2 PCR-positive test result >48 hour from time of admission, where COVID-19 diagnosis not suspected on admission. The projected sample size is 2380 patients. Intervention: The intervention is the return of a sequence report, within 48 hours in one phase (rapid local lab processing) and within 5-10 days in a second phase (mimicking central lab), comparing the viral genome from an eligible study participant with others within and outside the hospital site. Primary and secondary outcome measures The primary outcomes are incidence of Public Health England (PHE)/IPC-defined SARS-CoV-2 hospital-acquired infection during the baseline and two interventional phases, and proportion of hospital-onset cases with genomic evidence of transmission linkage following implementation of the intervention where such linkage was not suspected by initial IPC investigation. Secondary outcomes include incidence of hospital outbreaks, with and without sequencing data; actual and desirable changes to IPC actions; periods of healthcare worker (HCW) absence. Health economic analysis will be conducted to determine cost benefit of the intervention. A process evaluation using qualitative interviews with HCWs will be conducted alongside the study.

Item Type: Article
Additional Information: Funding information: The COG-UK HOCI study is funded by the COG-UK Consortium, which is supported by funding from the Medical Research Council (MRC) part of UK Research & Innovation (UKRI), the National Institute of Health Research (NIHR) and Genome Research Limited, operating as the Wellcome Sanger Institute (UKRI MRC Grant number MC PC 19027). Matthew Bashton, Andrew Nelson, Darren Smith, Greg Young and Clare McCann are members of the COVID-19 Genomics UK consortium.
Subjects: A300 Clinical Medicine
B100 Anatomy, Physiology and Pathology
B900 Others in Subjects allied to Medicine
C700 Molecular Biology, Biophysics and Biochemistry
Department: Faculties > Health and Life Sciences > Applied Sciences
Depositing User: Elena Carlaw
Date Deposited: 22 Jul 2022 15:27
Last Modified: 22 Jul 2022 15:30
URI: http://nrl.northumbria.ac.uk/id/eprint/49602

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