COG-UK Project Hospital-Onset COVID-19 Infections Study (COG-UK HOCI)
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|ClinicalTrials.gov Identifier: NCT04405934|
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : June 17, 2020
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 coronavirus 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.
Infection 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.
There 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. It 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.
The 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.
|Condition or disease||Intervention/treatment||Phase|
|Covid-19 Nosocomial Infection Coronavirus Coronavirus Infection SARS-CoV 2||Other: Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Phase III Prospective, Interventional, Cohort, Superiority Study to Evaluate the Benefit of Rapid COVID-19 Genomic Sequencing (the COVID-19 GENOMICS UK Project) on Infection Control in Preventing the Spread of the Virus in United Kingdom NHS Hospitals|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||April 2021|
Genomic-sequence informed IPC measures
Cohort follow baseline (no report receipt), then rapid vs standard sequencing report receipt phase, then return to baseline phase (no report receipt)
Other: Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures
Rapid or standard (time to return to sites) receipt of virus (Covid-19) genomic sequencing reports
- Incidence rates of IPC-defined hospital-onset COVID-19 infection (HOCIs) [ Time Frame: 6 months ]Incidence rate of IPC-defined HOCIs, measured as incidence rate of recorded cases per week per 100 inpatients, during each phase of the study based on case report forms.
- Change in incidence rates of IPC-defined HOCIs with rapid vs standard sequencing [ Time Frame: 6 months ]Identification of nosocomial transmission using sequencing data in potential HOCIs in whom this was not identified by pre-sequencing IPC evaluation, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.
- Incidence rates of IPC-defined hospital outbreaks [ Time Frame: 6 months ]Incidence rate of IPC-defined hospital outbreaks, defined as cases of hospital transmission linked by location and with intervals between diagnoses of no greater than 2 weeks (relevant data extracted from case report forms), measured as incidence rate of outbreak events per week per 100 inpatients during each phase of the study.
- Incidence rates of IPC+sequencing-defined hospital outbreaks [ Time Frame: 6 months ]Incidence rate of IPC+sequencing-defined hospital outbreaks, defined by retrospective review of all available sequencing and epidemiological data for identification of transmission clusters and measured as outbreak events per week per 100 inpatients during each phase of the study.
- Changes to IPC actions following viral sequence reports [ Time Frame: 6 months ]Changes to IPC actions implemented following receipt of viral sequence report, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.
- Recommended changes to IPC actions following viral sequence report - not implemented [ Time Frame: 6 months ]Changes to IPC actions that would ideally have been implemented (given unlimited resources) following receipt of viral sequence report, measured using pre- and post-sequencing case report forms for each enrolled patient during study phases in which the sequence reporting tool is in use.
- Health economic benefit to IPC of standard vs rapid sequencing reports [ Time Frame: 6 months ]Health economic benefit of standard and rapid sequencing reports to IPC measured using bespoke health economic case report data comparison between baseline, standard and rapid sequencing phases.
- Impact of both standard and rapid sequencing reports on number of HCW days off work [ Time Frame: 6 months ]Number of HCW days off work measured from sampling these data points on case report forms at all study phases.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405934
|Contact: Leanne Hockey||0203 108 email@example.com|
|Contact: James Blackstone||0203 108 firstname.lastname@example.org|
|Principal Investigator:||Judith Breuer, MD||University College, London|