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The McMaster Multi-Regional COVID-19 Hospital Case Registry

NCT ID: NCT04508959

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-15

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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Rationale: The novel coronavirus disease of 2019 (COVID-19) is a rapidly evolving pandemic, which poses a major and ongoing threat to health and the health system both globally and locally. While there have been country-specific case series that have offered some guidance on interventions that may be effective; applying them to local settings is problematic, given differences in population density, demographics (including vulnerable sub-populations), economic and political capacity. To this end, local data is needed to better inform on the timing and implementation of specific and targeted interventions to mitigate the spread and impact of the virus immediately, and thereafter. Near real-time information can greatly inform efforts and decisions needed to address resource allocation in response to the dynamic pandemic.

Objectives: The Investigators' aim is to collect data on the impact and burden of COVID-19 that can inform and support real-time local clinical and policy decisions. Specifically, the objectives are to: 1) Create a COVID-19 admission case registry as a local research and quality improvement platform for the COVID-19 pandemic; and 2) Collect data that can inform local pandemic decisions and evaluation, including incidence, vulnerability, complications, and clinical course of COVID-19 patients.

Methods: The investigators have established the McMaster Coronavirus (COVID-19) Registry (COREG), an ISARIC-WHO compatible, comprehensive platform that facilitates uniform data collection of COVID-19. COREG is an extension of the ISARIC-WHO case report form (CRF) designed to capture local information on transmission, disease- burden, course, and outcomes of COVID-19 cases from all COVID-19 charting hospitals in the Waterloo, Hamilton, and Niagara Regions of Ontario, Canada (Population \> 1,500,000). COREG is a comprehensive patient registry based retrospective data collection on all suspected and confirmed COVID-19 cases (according to the ISARIC definition) admitted to St. Joseph's Healthcare Hamilton (SJHH), Hamilton Health Sciences (HHS), Grand River Hospital, St. Mary's General Hospital, and the Niagara Health System. The registry includes data abstracted from existing chart data generated during routine clinical care. A waiver of informed consent is granted. Data categories to be collected follow the ISARIC-WHO CRF (https://isaric.tghn.org/covid-19-clinical-research-resources/) and include demographics, co-morbidities, pre-admission medications, signs and symptoms, diagnostic results, in-hospital interventions and health outcomes (medical complications during hospitalization including ICU and death). Cases are identified by the Infection Prevention and Control (IPAC) at each site and records will be accessed remotely and securely by research and medical staff. Extracted data are stored in a secure McMaster hosted REDCap and data server. Data collectors undergo a standardized training. Weekly governance meetings occur between the data collectors, operational leads and clinical site lead at each site to discuss, address and resolve any barriers and inconsistences in data collection and advance the scientific agenda.

Impact: COREG ensures that COVID-19 data collected are standardized and robust and will have a meaningful impact on local decision-making, while also being comparable internationally. COREG will shape consensus recommendations on inpatient management of hospitalized patients with COVID-19. It will be invaluable to local and global research efforts, since linkage to tissue biobanks and other administrative databases can be easily performed to address questions on pathophysiology, long-term outcomes and healthcare burden.

Conditions

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Coronavirus Infection Coronavirus SARS-CoV-2 Infection Covid19

Keywords

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Registry

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Screened patients

All individuals screened using the hospital's microbiology laboratory.

No interventions assigned to this group

Outpatient (Emergency Department) cases

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

No interventions assigned to this group

Inpatient (General Medical or Intensive Care) cases

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Hamilton Academic Health Sciences Organization

OTHER

Sponsor Role collaborator

Grand River Hospital

OTHER

Sponsor Role collaborator

Niagara Health System

OTHER

Sponsor Role collaborator

St. Mary's General Hospital

UNKNOWN

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Andrew Costa

Associate Professor and Schlegel Chair in Clinical Epidemiology & Aging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca J Kruisselbrink, MD, MPH, FRCPC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

MyLinh Duong, MBBS, MSc, FRACP

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Terence Ho, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Andrew P Costa, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Marla Beauchamp, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Jennifer Tsang, MD, PhD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status RECRUITING

Grand River Hospital

Kitchener, Ontario, Canada

Site Status RECRUITING

St. Mary's General Hospital

Kitchener, Ontario, Canada

Site Status RECRUITING

Niagara Health System

St. Catharines, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Andrew P Costa, PhD

Role: CONTACT

Phone: 5197296285

Email: [email protected]

Darly Dash, MSc

Role: CONTACT

Email: [email protected]

Facility Contacts

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Mats L Junek, MD, MSc

Role: primary

Jessica Kapralik, MD (PGY5)

Role: primary

Tyler Pitre, MA, MD (PGIM)

Role: primary

Tyler Pitre, MA, MD (PGIM)

Role: primary

Lisa Patterson

Role: primary

Other Identifiers

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172754

Identifier Type: -

Identifier Source: org_study_id