COG-UK Project Hospital-Onset COVID-19 Infections Study

NCT04405934 | Completed DMC

• 3 other identifiers: CTU/2020/35328301420/EE/0118
• Study Type: interventional
• Target: 2,170
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Covid-19; Nosocomial Infection; Coronavirus; Coronavirus Infection; SARS-CoV 2

Keywords

Nosocomial Covid-19; Covid-19; Coronavirus; Infection Prevention and Control

Outcome Measures

Primary Outcomes (2)

• Incidence rates of IPC-defined hospital-onset COVID-19 infection (HOCIs)

  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.

  6 months

• Change in incidence rates of IPC-defined HOCIs with rapid vs standard sequencing

  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.

  6 months

Secondary Outcomes (6)

• Incidence rates of IPC-defined hospital outbreaks

  6 months

• Incidence rates of IPC+sequencing-defined hospital outbreaks

  6 months

• Changes to IPC actions following viral sequence reports

  6 months

• Recommended changes to IPC actions following viral sequence report - not implemented

  6 months

• Health economic benefit to IPC of standard vs rapid sequencing reports

  6 months

Study Arms (1)

Genomic-sequence informed IPC measures

OTHER

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

Interventions

Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures OTHER

Rapid or standard (time to return to sites) receipt of virus (Covid-19) genomic sequencing reports

Genomic-sequence informed IPC measures

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have confirmed COVID-19 infection and either:
• be a potential hospital-onset COVID-19 infection (HOCI); or
• potential workplace infection from COV-SARS-2 for site-based healthcare workers.
• Participants must have provided nasal swab/pharyngeal swab / combined nasal and pharyngeal swab / nasopharyngeal aspirate or broncho alveolar lavage sample for evaluation in the COG-UK project.
• Participants may be of any age to be included in study For clarity, in the above criterion a potential HOCI is an admitted patient at site with first confirmed test for COVID-19 \>48 hours after admission, where they were not suspected to have COVID-19 at time of admission.

Sponsors & Collaborators

• University College, London: lead
• Public Health England: collaborator

Study Sites (1)

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Location

Related Publications (1)

• Stirrup O, Blackstone J, Mapp F, MacNeil A, Panca M, Holmes A, Machin N, Shin GY, Mahungu T, Saeed K, Saluja T, Taha Y, Mahida N, Pope C, Chawla A, Cutino-Moguel MT, Tamuri A, Williams R, Darby A, Robertson DL, Flaviani F, Nastouli E, Robson S, Smith D, Loose M, Laing K, Monahan I, Kele B, Haldenby S, George R, Bashton M, Witney AA, Byott M, Coll F, Chapman M, Peacock SJ; COG-UK HOCI Investigators; COVID-19 Genomics UK (COG-UK) consortium; Hughes J, Nebbia G, Partridge DG, Parker M, Price JR, Peters C, Roy S, Snell LB, de Silva TI, Thomson E, Flowers P, Copas A, Breuer J. Effectiveness of rapid SARS-CoV-2 genome sequencing in supporting infection control for hospital-onset COVID-19 infection: Multicentre, prospective study. Elife. 2022 Sep 13;11:e78427. doi: 10.7554/eLife.78427.

  PMID: 36098502 DERIVED

MeSH Terms

Conditions

COVID-19; Cross Infection; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Judith Breuer, MD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Superiority model: 1. Baseline/control phase 1 Sample collection and genomic sequencing from Covid-19 positive participants suspected of acquiring infection in hospital (suspected nosocomial Covid-19 infection where tested positive \>48 hours after hospital admission) where sequencing reports not interpreted/actioned by Infection Prevention Control (IPC) site teams 2. Site intervention phase Sample collection and genomic sequencing from Covid-19 positive participants suspected of acquiring infection in hospital where sequencing reports generated both rapid or standard and received by site IPC teams for interpretation and action 3. Control phase 2 (prospective) Sample collection and genomic sequencing from Covid-19 positive participants suspected of acquiring infection in hospital where sequencing reports not interpreted/actioned by IPC site teams - where deemed ethical and approved by oversight committees i.e. DMEC.

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 28, 2020
• Study Start: October 15, 2020
• Primary Completion: April 26, 2021
• Study Completion: October 8, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: This will be done with 6 months of public reporting of results, with data available for 5 years.
• Access Criteria: Fully open access

Locations

GB (1)