COG-UK HOCI study [COVID-19] [UPH]
Research type
Research Study
Full title
For COVID-19 the risk of within hospital spread of infection presents a significant health risk to healthcare workers. There is good evidence that genome sequencing (determining the genetic code) of viruses such as that which causes COVID-19, together with standard infection prevention and control (IPC) can reduce within hospital infection rates more effectively than just existing IPC practice and may help identify how the virus is transmitted. This study will investigate the benefit of genome sequencing and whether rapid (24-48h) turnaround of genome sequencing information to IPC teams has an effect on infection rates. \nAt the beginning of the study participating NHS hospital teams will be asked to record IPC information as usual for a short time to collect control information. After this (the intervention phase) blood samples from patients with a confirmed COVID-19 infection thought to have been transmitted within hospital will be sent for genome sequencing and the information will be fed back to the hospital teams. A final phase without the genome sequencing may take place to collect additional information on standard IPC practice once the COVID-19 outbreak is at a low level nationwide.
IRAS ID
283014
Contact name
Judith Breuer
Contact email
Sponsor organisation
University College London
ISRCTN Number
ISRCTN50212645
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary
Hospitals are recognised to be a major risk for the spread of infections despite the availability of protective measures. Under normal circumstances, staff may acquire and transmit infections, but the health impact of within hospital infection is greatest in vulnerable patients. For the novel coronoavirus that causes COVID-19, like recent outbreaks such as the SARS and Ebola virus, the risk of within hospital spread of infection presents an additional, significant health risk to healthcare workers.\n\nInfection Prevention and Control (IPC) teams within hospitals engage in practices that minimise the number of infections acquired within hospital. This includes surveillance of infection spread, and proactively leading on training to clinical and other hospital teams.\n\nThere is now good evidence that genome sequencing of epidemic viruses such as that which causes COVID-19, together with standard IPC, more effectively reduces within hospital infection rates and may help identify the routes of transmission, than just existing IPC practice. \n\nIt is proposed to evaluate the benefit of genome sequencing in this context, and whether rapid (24-48h) turnaround on the data to IPC teams has an impact on that level of benefit.\n\nThe study team will ask participating NHS hospitals to collect IPC information as per usual practice for a short time to establish data for comparison. Where patients are confirmed to have a COVID-19 infection thought to have been transmitted within hospital, their samples will be sequenced with data fed back to hospital teams during the intervention phase. A final phase without the intervention may take place for additional information on standard IPC practice when the COVID-19 outbreak is at a low level nationwide.[Study relying on COPI notice]
Summary of Results
A total of 2170 hospital onset Covid-19 infection (HOCI) cases were recorded at the 14 NHS Trusts participating in the COG-UK HOCI study from October 2020 to April 2021. This corresponded to a period of extreme strain on the UK national health service (NHS) due to the first Alpha-variant wave of Covid-19 in the UK.
As a result, SARS-Cov-2 genome sequence comparison reports were only returned for 650/1320 (49.2%) during the two intervention phases (rapid and longer turnaround time of the genome sequence report).
The team did not detect a statistically significant change in weekly incidence of hospital-acquired infections (HAIs) in longer-turnaround or rapid intervention phases compared to baseline phase.
However, Infection Prevention and Control (IPC) practice was changed in 7.8 and 7.4% of all HOCI cases in rapid and longer-turnaround phases, respectively, and 17.2 and 11.6% of cases where the genome sequence report was returned.
In a 'per-protocol' sensitivity analysis (i.e. only data obtained under the conditions as specified in the trial protocol), there was an impact on IPC actions in 20.7% of HOCI cases when the genome sequence report was returned within 5 days.
NHS IPC team capacity to respond effectively to insights from the sequencing reports was breached in most sites by the volume of cases and limited additional resources available at the time.
While the trial team did not demonstrate a direct impact of genome sequencing on the incidence of nosocomial (within-hospital) transmission, the results suggest that in the future genome sequencing can inform ongoing IPC response to hospital-onset Covid-19 cases, particularly when returned within 5 days.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
20/EE/0118
Date of REC Opinion
23 Apr 2020
REC opinion
Favourable Opinion