Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The McMaster Multi-Regional COVID-19 Hospital Case Registry (COREG)

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: NCT04508959
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : November 24, 2020
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Hamilton Academic Health Sciences Organization
Grand River Hospital
Niagara Health System
St. Mary's General Hospital
Hamilton Health Sciences Corporation
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
Andrew Costa, McMaster University

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.

Condition or disease
Coronavirus Infection Coronavirus SARS-CoV-2 Infection Covid19

Detailed Description:

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: A Rapid Research Platform to Inform Prevention & Improve the Clinical Management of COVID-19 Illness for Priority Older Adult Groups: The McMaster Multi-regional Hospital Coronavirus Registry
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Group/Cohort
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 Measures :
  1. Serious COVID-19 infection [ Time Frame: through study completion, an average of 1 year ]
    Defined as symptomatic hospital outpatients with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) through the COREG platform.

  2. Severe infection (requiring admission) [ Time Frame: through study completion, an average of 1 year ]
    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.

  3. COVID-19 related death [ Time Frame: through study completion, an average of 1 year ]
    Defined as persons who died with laboratory confirmed SARS-CoV-2 (based on the ISARIC definition) available through the COREG platform.


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: through study completion, an average of 1 year ]
    Days from admission to discharge.

  2. Complications [ Time Frame: through study completion, an average of 1 year ]
    New or increased severity of conditions and syndromes from pre-morbid state.

  3. Intensive interventions [ Time Frame: through study completion, an average of 1 year ]
    Rate of intensive interventions during hospital stay.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria

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.

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): NCT04508959


Contacts
Layout table for location contacts
Contact: Andrew P Costa, PhD 5197296285 acosta@mcmaster.ca
Contact: Darly Dash, MSc dashd@mcmaster.ca

Locations
Layout table for location information
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L2X2
Contact: Mats L Junek, MD, MSc       mats.junek@medportal.ca   
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L9C0E3
Contact: Jessica Kapralik, MD (PGY5)       jessica.kapralik@medportal.ca   
Grand River Hospital Recruiting
Kitchener, Ontario, Canada, N2G1G3
Contact: Tyler Pitre, MA, MD (PGIM)       tyler.pitre@medportal.ca   
St. Mary's General Hospital Recruiting
Kitchener, Ontario, Canada, N2M1B2
Contact: Tyler Pitre, MA, MD (PGIM)       tyler.pitre@medportal.ca   
Niagara Health System Recruiting
St. Catharines, Ontario, Canada, L2S0A9
Contact: Lisa Patterson       lisa.patterson@niagarahealth.on.ca   
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Hamilton Academic Health Sciences Organization
Grand River Hospital
Niagara Health System
St. Mary's General Hospital
Hamilton Health Sciences Corporation
St. Joseph's Healthcare Hamilton
Investigators
Layout table for investigator information
Principal Investigator: 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
Layout table for additonal information
Responsible Party: Andrew Costa, Associate Professor and Schlegel Chair in Clinical Epidemiology & Aging, McMaster University
ClinicalTrials.gov Identifier: NCT04508959    
Other Study ID Numbers: 172754
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: WHO-ISARIC COVID-19 database (https://isaric.tghn.org/covid-19-clinical-research-resources/).
Time Frame: Entire registry

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew Costa, McMaster University:
Registry
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases