Recruiting

Observational Study

Sponsor:

McMaster University

Code:

NCT04508959

Conditions

Coronavirus Infection

Coronavirus

SARS-CoV-2 Infection

Covid19

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The McMaster Multi-Regional Hospital Coronavirus Registry (COREG) is a platform that is collecting detailed case data on laboratory confirmed COVID-19 hospital inpatients and outpatients. The COREG platform will provide rapid high-quality evidence to improve the prevention and clinical management of COVID-19 for older adults in Canada, and internationally. The COREG platform will also provide researchers and partners with complete regional level clinical data on COVID-19 cases to inform rapid decision-making and projections, sub-studies, extensions, and linkage for all affected populations.

Conditions

Coronavirus Infection

Coronavirus

SARS-CoV-2 Infection

Covid19

Study ID

NCT04508959

Start date

Apr 15, 2020

Status verified date

Nov, 2020

Completion date

Jul, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Persons tested positive for SARS-CoV-2 using hospital facilities
  • Patients seen or admitted with confirmed COVID-19 to the hospital

Exclusion Criteria:

  • The pragmatic nature of the registry warrants the broadest inclusion criteria that are feasible. In keeping with the pragmatic nature of this registry, no exclusions are introduced.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Screened patients

All individuals screened using the hospital's microbiology laboratory.

Outpatient (Emergency Department) cases

All individuals seen in the emergency department who test positive for COVID-19.

Inpatient (General Medical or Intensive Care) cases

All individuals admitted to a general or intensive care bed who test positive for COVID-19.

Primary outcome measure

  • Serious COVID-19 infection [ Time Frame: through study completion, an average of 1 year ]
  • Severe infection (requiring admission) [ Time Frame: through study completion, an average of 1 year ]
  • COVID-19 related death [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Andrew P Costa, PhD

5197296285acosta@mcmaster.ca

Darly Dash, MSc

dashd@mcmaster.ca

Locations

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L2X2

Contacts

Mats L Junek, MD, MSc

mats.junek@medportal.ca

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L9C0E3

Contacts

Jessica Kapralik, MD (PGY5)

jessica.kapralik@medportal.ca

Grand River Hospital

Recruiting

Kitchener, Ontario, Canada, N2G1G3

Contacts

Tyler Pitre, MA, MD (PGIM)

tyler.pitre@medportal.ca

St. Mary's General Hospital

Recruiting

Kitchener, Ontario, Canada, N2M1B2

Contacts

Tyler Pitre, MA, MD (PGIM)

tyler.pitre@medportal.ca

Niagara Health System

Recruiting

St. Catharines, Ontario, Canada, L2S0A9

Contacts

Lisa Patterson

lisa.patterson@niagarahealth.on.ca

More Information

Sponsor

McMaster University

Last update posted

Nov 24, 2020

Last verified

Nov, 2020

Keywords

  • Registry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2020-11-24.