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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

Authors :
Judith Breuer
David Partridge
Monica Panca
Paul Flowers
Gaia Nebbia
Fiona Mapp
Andrew Copas
Oliver Stirrup
James Price
Emma Thomson
Asif Tamuri
Matthew Parker
Sunando Roy
Joseph Hughes
Thushan de Silva
James Blackstone
Leanne Hockey
Christine Peters
Luke B Snell
Rachel McComish
Stefan Piatek
Joshua Singer
Source :
BMJ Open, Vol 12, Iss 4 (2022)
Publication Year :
2022
Publisher :
BMJ Publishing Group, 2022.

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.Trial registration number ISRCTN50212645. Pre-results stage. This manuscript is based on protocol V.6.0. 2 September 2021.

Subjects

Subjects :
Medicine

Details

Language :
English
ISSN :
20446055
Volume :
12
Issue :
4
Database :
Directory of Open Access Journals
Journal :
BMJ Open
Publication Type :
Academic Journal
Accession number :
edsdoj.0e8c0795dd5144b380c7bebc8b0738e5
Document Type :
article
Full Text :
https://doi.org/10.1136/bmjopen-2021-052514