COVID-19 Genomic Sequencing for Nosocomial Outbreak Investigations

COVID-19 Clinical Trial

— NOSO-COVID  

Official title:

On-Demand Point-of-Care SARS-CoV-2 Genomic Sequencing to Support Nosocomial Outbreak Investigations: A Prospective Molecular Epidemiology Study in Montreal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411562
• Other study ID #: 20.270
• Status: Recruiting
• Start date: November 9, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Simon Grandjean Lapierre, MD MSc FRCPC
• Phone: 514-890-8000
• Email: sgrandjeanlapierre[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a tertiary care hospital-based prospective molecular epidemiology study in Montreal, Canada. When nosocomial transmission was suspected by local infection control teams' investigations, SARS-CoV-2 viral genomic sequencing was performed locally for all putative outbreak cases and contemporary controls. Molecular and conventional epidemiology data were confronted in real time to improve understanding of COVID-19 transmission and reinforce or adapt prevention measures.

Description:

This study will include infected healthcare workers (HCW) and patients for whom a nosocomial infection in CHUM is suspected. The CHUM laboratory is responsible for COVID-19 diagnostic testing in all eligible HCW and patients. After initial diagnosis on standard PCR testing, samples are maintained at -80. Viral RNA is extracted and next-generation sequencing of the viral genome is performed using Nanopore long read sequencing platform. Preliminary data suggest that SARS-CoV-2 has a "molecular clock" of 2 single nucleotide polymorphism (SNP) per month. The analysis and between-isolate comparaison of those SNP among epidemiologically related cases will allow to support or refute the hypothesis of person to person nosocomial transmission. All infected patients will be matched 1:1 with contemporary community cases to provide a viral genome back catalog and better contextualize molecular epidemiology analyses. Molecular clusters will be reported to infection prevention and control teams and resulting interventions will be monitored.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Hospitalized in the institution during the study period

• Healthcare workers in the institution during the study period

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• COVID-19
• Cross Infection
• Molecular Sequence Variation
• Nosocomial Infection

Intervention

Diagnostic Test:
• SARS-CoV-2 genomic sequencing
SARS-CoV-2 viral genomic sequencing and phylogenetic analyses

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outbreak control measures improvement	Collaborative (infection control and molecular epidemiology teams) resolution of putative outbreaks. Transmission is either refuted or further supported by molecular analyses. Additional investigation efforts are discontinued or necessary corrective measures are implemented.	Through study completion, an average of 2 years