Canadian COVID-19 Emergency Department Registry (CCEDRRN)

January 7, 2021 updated by: Corinne Hohl, University of British Columbia

Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) - Population-based Registry of Suspected and Confirmed COVID-19 Cases

Coronavirus Disease 2019 (COVID -19) is the largest public health crisis in over a century. There is an urgent need for high-quality population-level data to understand modifiable risks for disease severity, transmissibility, and to develop evidence-based prevention (i.e. vaccination), treatment and resource allocation strategies.

The Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) created a population-based registry of suspected and confirmed consecutive cases of COVID-19. The purpose of this registry is to derive and validate clinical decision rules, evaluate diagnostic tests and vaccine effectiveness, and complete cohort, case-control and observational studies to inform the pandemic response.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This national multi-centre registry is designed to enroll population-based consecutive eligible patients presenting with suspected or confirmed COVID-19 to 50 emergency departments in eight Canadian provinces from March 1 2020 and data collection is ongoing for the duration of the pandemic.

Data will be abstracted from the medical chart and entered into a central, web-based REDCap database. The investigators adopted the ISARIC variables into the database where there was a match. The investigators will develop standardized operating procedures for screening of potentially eligible patients, data entry and follow-up. Current data dictionaries are kept on the registry's website (https://canadiancovid19registry.org/).

At 30 days, the investigators will contact patients by telephone to obtain verbal consent for follow-up. The investigators will measure the Veterans Rand 12-item Health Survey (VR12), calculate the WHO Ordinal Outcome Scale and ask contextual questions in consenting patients. The VR12 will be measured at 60 days, and 6 and 12 months. The contextual questions were developed with input from patients with lived experience with COVID-19 infection and addressed cultural, racial, gender, socioeconomic and self-isolation issues.

The Health Data Research Network facilitated the development of a unique data flow of personal health identifiers and study identification numbers from each province for all participating institutes. This will allow linkage of registry data with national administrative data repositories.

Study Type

Observational

Enrollment (Anticipated)

200000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Recruiting
        • Foothills Medical Centre
      • Calgary, Alberta, Canada
        • Recruiting
        • Rockyview General Hospital
      • Calgary, Alberta, Canada
        • Recruiting
        • Peter Lougheed Centre
      • Calgary, Alberta, Canada
        • Recruiting
        • South Health Campus
      • Edmonton, Alberta, Canada
        • Recruiting
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada
        • Recruiting
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada
        • Recruiting
        • Northeast Community Health Centre
    • British Columbia
      • Abbotsford, British Columbia, Canada
        • Recruiting
        • Abbotsford Regional Hospital
      • Kamloops, British Columbia, Canada
        • Recruiting
        • Royal Inland Hospital
      • Kelowna, British Columbia, Canada
        • Recruiting
        • Kelowna General Hospital
      • New Westminster, British Columbia, Canada
        • Recruiting
        • Royal Columbian Hospital
      • North Vancouver, British Columbia, Canada
        • Recruiting
        • Lions Gate Hospital
      • Port Moody, British Columbia, Canada
        • Recruiting
        • Eagle Ridge Hospital
      • Surrey, British Columbia, Canada
        • Recruiting
        • Surrey Memorial Hospital
      • Vancouver, British Columbia, Canada
        • Recruiting
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada
        • Recruiting
        • St. Paul's Hospital
      • Vancouver, British Columbia, Canada
        • Recruiting
        • Mount Saint Joseph Hospital
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Recruiting
        • Saint John Regional Hospital
    • Nova Scotia
      • Dartmouth, Nova Scotia, Canada
        • Recruiting
        • Dartmouth General Hospital
      • Halifax, Nova Scotia, Canada
        • Recruiting
        • Halifax Infirmary
      • Lower Sackville, Nova Scotia, Canada
        • Recruiting
        • Cobequid Community Health Centre
      • Windsor, Nova Scotia, Canada
        • Recruiting
        • Hants Community Hospital
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • Hamilton General Hospital
      • Hamilton, Ontario, Canada
        • Recruiting
        • Juravinski Hospital
      • Kingston, Ontario, Canada
        • Recruiting
        • Hotel Dieu Hospital
      • Kingston, Ontario, Canada
        • Recruiting
        • Kingston General Hospital
      • London, Ontario, Canada
        • Recruiting
        • London Health Sciences Centre (University Hospital)
      • London, Ontario, Canada
        • Recruiting
        • London Health Sciences Centre (Victoria Hospital)
      • Ottawa, Ontario, Canada
        • Recruiting
        • The Ottawa Hospital - General Campus
      • Ottawa, Ontario, Canada
        • Recruiting
        • The Ottawa Hospital - Civic Campus
      • Sudbury, Ontario, Canada
        • Recruiting
        • Health Science North
      • Toronto, Ontario, Canada
        • Recruiting
        • Toronto Western Hospital
      • Toronto, Ontario, Canada
        • Recruiting
        • North York General Hospital
      • Toronto, Ontario, Canada
        • Recruiting
        • Sunnybrook Hospital
    • Quebec
      • Lévis, Quebec, Canada
        • Recruiting
        • Hotel-Dieu de Levis
      • Montréal, Quebec, Canada
        • Recruiting
        • Jewish General Hospital
      • Montréal, Quebec, Canada
        • Recruiting
        • Hopital du Sacre-Coeur
      • Montréal, Quebec, Canada
        • Recruiting
        • Montréal General Hospital (MUHC)
      • Montréal, Quebec, Canada
        • Recruiting
        • Royal Victoria Hospital (MUHC)
      • Québec, Quebec, Canada
        • Recruiting
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
      • Québec, Quebec, Canada
        • Recruiting
        • Centre Hospitalier de l'Université Laval (CHU de Québec)
      • Québec, Quebec, Canada
        • Recruiting
        • Hôpital de l'Enfant-Jésus (CHU de Québec)
      • Québec, Quebec, Canada
        • Recruiting
        • Hôpital du Saint-Sacrement (CHU de Québec)
      • Québec, Quebec, Canada
        • Recruiting
        • Hôpital Saint-François d'Assise (CHU de Québec)
      • Québec, Quebec, Canada
        • Recruiting
        • Hôtel-Dieu de Québec (CHU de Québec)
    • Saskatchewan
      • Regina, Saskatchewan, Canada
        • Recruiting
        • Regina General Hospital
      • Regina, Saskatchewan, Canada
        • Recruiting
        • Pasqua Hospital
      • Saskatoon, Saskatchewan, Canada
        • Recruiting
        • Saskatoon City Hospital
      • Saskatoon, Saskatchewan, Canada
        • Recruiting
        • Royal University
      • Saskatoon, Saskatchewan, Canada
        • Recruiting
        • St Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to participating Canadian emergency departments with suspected and or confirmed COVID-19.

Description

The investigators defined two periods for enrollment based on the availability of COVID-19 testing. Research assistants used medical microbiology testing and discharge diagnoses to screen for potentially eligible patients.

In Period 1, COVID-19 testing in each province was restricted to specific patient populations (e.g., healthcare workers, admitted patients).

Inclusion Criteria:

  • Meeting the WHO suspect COVID-19 criteria: Fever (self-reported or subjective fever) and at least one symptom/sign of respiratory illness (e.g., flu-like illness, cough, shortness of breath)
  • Presenting to the emergency department and tested for COVID-19 in the emergency department

No exclusion criteria in Period 1

Period 2 started on the date which each province expanded testing criteria allowing clinicians to test patients based on clinical suspicion or policy.

Inclusion Criteria:

  • Presenting to the emergency department within 14 days of a positive COVID-19 (by self-report or in medical chart) and presents with clinical symptoms consistent with COVID-19
  • Tested for COVID-19 in the emergency department, or within 24 hours after emergency department arrival.

Exclusion Criteria

  • Patients tested for COVID-19 in the context of an elective admission (e.g., planned hip revision)
  • Patients tested for COVID-19 and seen in the emergency department directly by another service (e.g., trauma team activation)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Registry participants
Patients presenting to participating emergency departments with suspected and or confirmed COVID-19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed COVID-19 diagnosis
Time Frame: 14 days
Biological specimen is tested positive for SARS-CoV-2 using reverse transcription polymerase chain reaction (RT PCR). The specimen had to be drawn within two weeks of the emergency department visit if the patient presented with a COVID-19-related complication. If the initial test was negative, the patient had to have a positive specimen within 14 days of the index visit.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital admission
Time Frame: 30 days
Any hospital admission within 30 days of index emergency department visit captured in medical chart.
30 days
Mechanical ventilation
Time Frame: 30 days
Any mechanical ventilation during any hospital visit within 30 days of index emergency department visit captured in medical chart.
30 days
Emergency department revisits
Time Frame: 30 days
Any emergency department revisits within 30 days of index emergency department visit captured in medical chart.
30 days
Hospital re-admissions
Time Frame: 30 days
Any hospital re-admissions within 30 days of index emergency department visit date captured in medical chart.
30 days
30 day mortality
Time Frame: 30 days
Any death captured within 30 days of index emergency department visit captured by medical charts.
30 days
Clinical recovery
Time Frame: 30 days
Captured through telephone follow-up using the World Health Organization Ordinal Outcome Scale at 30 days after index emergency department visit. The scale is scored from 1 to 8 ('1'= no limitations to activities, '8'=death) to measure clinical improvement at 30 days.
30 days
Patient quality of life
Time Frame: 12 months
Captured through telephone follow-up using the Veterans Rand 12-item Health Survey at 30 days, 60 days, and 6 and 12 months after index emergency department visit.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)
Genome British Columbia
Canadian Critical Care Trials Group

Investigators

  • Principal Investigator: Corinne M Hohl, MD, MSc, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

January 6, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H20-01015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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