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COG-UK Project Hospital-Onset COVID-19 Infections Study (COG-UK HOCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04405934
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
Public Health England
Information provided by (Responsible Party):
University College, London

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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Sequential Assignment
Intervention Model Description:

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.
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have confirmed COVID-19 infection and either:

    1. be a potential hospital-onset COVID-19 infection (HOCI); or
    2. 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.

Exclusion Criteria:

- There are no exclusion criteria for COG-UK HOCI


Information from the National Library of Medicine

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


Contacts
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Contact: Leanne Hockey 0203 108 5970 l.hockey@ucl.ac.uk
Contact: James Blackstone 0203 108 6584 j.blackstone@ucl.ac.uk

Sponsors and Collaborators
University College, London
Public Health England
Investigators
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Principal Investigator: Judith Breuer, MD University College, London
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04405934    
Other Study ID Numbers: CTU/2020/353
283014 ( Other Identifier: IRAS )
20/EE/0118 ( Other Identifier: REC reference )
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Nosocomial Covid-19
Covid-19
Coronavirus
Infection Prevention and Control
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Cross Infection
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Iatrogenic Disease
Disease Attributes
Pathologic Processes