NCT04508959

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

August 10, 2020

Last Update Submit

November 21, 2020

Conditions

Coronavirus InfectionCoronavirusSARS-CoV-2 InfectionCovid19

Keywords

Registry

Outcome Measures

Primary Outcomes (3)

  • Serious COVID-19 infection

    Defined as symptomatic hospital outpatients with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) through the COREG platform.

    through study completion, an average of 1 year

  • Severe infection (requiring admission)

    Defined as persons admitted with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) available through the COREG platform. We will also conduct sub analyses of hospital acquired COVID-19 also captured in the COREG platform.

    through study completion, an average of 1 year

  • COVID-19 related death

    Defined as persons who died with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) available through the COREG platform.

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • Length of stay

    through study completion, an average of 1 year

  • Complications

    through study completion, an average of 1 year

  • Intensive interventions

    through study completion, an average of 1 year

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

RECRUITING

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L9C0E3, Canada

RECRUITING

Grand River Hospital

Kitchener, Ontario, N2G1G3, Canada

RECRUITING

St. Mary's General Hospital

Kitchener, Ontario, N2M1B2, Canada

RECRUITING

Niagara Health System

St. Catharines, Ontario, L2S0A9, Canada

RECRUITING

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Rebecca J Kruisselbrink, MD, MPH, FRCPC

    McMaster University

    PRINCIPAL INVESTIGATOR

  • MyLinh Duong, MBBS, MSc, FRACP

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Terence Ho, MD, FRCP

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Andrew P Costa, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Marla Beauchamp, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Jennifer Tsang, MD, PhD, FRCPC

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew P Costa, PhD

CONTACT

5197296285acosta@mcmaster.ca

Darly Dash, MSc

CONTACT

dashd@mcmaster.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Schlegel Chair in Clinical Epidemiology & Aging

Study Record Dates

First Submitted

August 10, 2020

First Posted

August 11, 2020

Study Start

April 15, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

WHO-ISARIC COVID-19 database (https://isaric.tghn.org/covid-19-clinical-research-resources/).

Time Frame
Entire registry

Locations

CA(5)