Clinical trial NCT04702945: Canadian COVID-19 Emergency Department Registry
Official title: Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) - Population-based Registry of Suspected and Confirmed COVID-19 Cases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Keywords: Coronavirus
Infectious diseases
Registry
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Genome British Columbia
name: Canadian Institutes of Health Research (CIHR)
name: Canadian Critical Care Trials Group
First posted: 2021-01-11
Enrollment: 200000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to participating Canadian emergency departments with suspected and or confirmed COVID-19.

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Confirmed COVID-19 diagnosis
timeFrame: 14 days
Secondary outcomes:
measure: Hospital admission
timeFrame: 30 days
measure: Mechanical ventilation
timeFrame: 30 days
measure: Emergency department revisits
timeFrame: 30 days
measure: Hospital re-admissions
timeFrame: 30 days
measure: 30 day mortality
timeFrame: 30 days
measure: Clinical recovery
timeFrame: 30 days
measure: Patient quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Calgary
country: Canada
facility: Rockyview General Hospital
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
city: Edmonton
country: Canada
facility: Northeast Community Health Centre
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Abbotsford
country: Canada
facility: Abbotsford Regional Hospital
state: British Columbia
city: Kamloops
country: Canada
facility: Royal Inland Hospital
state: British Columbia
city: Kelowna
country: Canada
facility: Kelowna General Hospital
state: British Columbia
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: North Vancouver
country: Canada
facility: Lions Gate Hospital
state: British Columbia
city: Port Moody
country: Canada
facility: Eagle Ridge Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Mount Saint Joseph Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Dartmouth
country: Canada
facility: Dartmouth General Hospital
state: Nova Scotia
city: Halifax
country: Canada
facility: Halifax Infirmary
state: Nova Scotia
city: Lower Sackville
country: Canada
facility: Cobequid Community Health Centre
state: Nova Scotia
city: Windsor
country: Canada
facility: Hants Community Hospital
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre (University Hospital)
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre (Victoria Hospital)
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Civic Campus
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Sudbury
country: Canada
facility: Health Science North
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Lévis
country: Canada
facility: Hôtel-Dieu de Lévis
state: Quebec
city: Montréal
country: Canada
facility: Hôpital du Sacré-Coeur
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: Montréal General Hospital (MUHC)
state: Quebec
city: Montréal
country: Canada
facility: Royal Victoria Hospital (MUHC)
state: Quebec
city: Québec
country: Canada
facility: Centre Hospitalier de l'Université Laval (CHU de Québec)
state: Quebec
city: Québec
country: Canada
facility: Hôpital de l'Enfant-Jésus (CHU de Québec)
state: Quebec
city: Québec
country: Canada
facility: Hôpital du Saint-Sacrement (CHU de Québec)
state: Quebec
city: Québec
country: Canada
facility: Hôpital Saint-François d'Assise (CHU de Québec)
state: Quebec
city: Québec
country: Canada
facility: Hôtel-Dieu de Québec (CHU de Québec)
state: Quebec
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
city: Regina
country: Canada
facility: Pasqua Hospital
state: Saskatchewan
city: Regina
country: Canada
facility: Regina General Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Royal University
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon City Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: St Paul's Hospital
state: Saskatchewan
Study officials:
affiliation: University of British Columbia
name: Corinne M Hohl, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis P, Rosychuk R, Hau JP, Cheng I, McRae AD, Daoust R, Lang E, Turner J, Khangura J, Fok PT, Stachura M, Brar B, Hohl CM; CCEDRRN investigators, and for the Network of Canadian Emergency Researchers and the Canadian Critical Care Trials Group. Diagnostic yield of screening for SARS-CoV-2 among patients admitted to hospital for alternate diagnoses: an observational cohort study. BMJ Open. 2022 Aug 10;12(8):e057852. doi: 10.1136/bmjopen-2021-057852.
citation: Hohl CM, Rosychuk RJ, Hau JP, Hayward J, Landes M, Yan JW, Ting DK, Welsford M, Archambault PM, Mercier E, Chandra K, Davis P, Vaillancourt S, Leeies M, Small S, Morrison LJ; Canadian COVID-19 Rapid Response Network (CCEDRRN) investigators for the Network of Canadian Emergency Researchers, for the Canadian Critical Care Trials Group. Treatments, resource utilization, and outcomes of COVID-19 patients presenting to emergency departments across pandemic waves: an observational study by the Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN). CJEM. 2022 Jun;24(4):397-407. doi: 10.1007/s43678-022-00275-3. Epub 2022 Apr 1.
citation: Hohl CM, Rosychuk RJ, Archambault PM, O'Sullivan F, Leeies M, Mercier E, Clark G, Innes GD, Brooks SC, Hayward J, Ho V, Jelic T, Welsford M, Sivilotti MLA, Morrison LJ, Perry JJ; Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) investigators for the Network of Canadian Emergency Researchers and the Canadian Critical Care Trials Group. The CCEDRRN COVID-19 Mortality Score to predict death among nonpalliative patients with COVID-19 presenting to emergency departments: a derivation and validation study. CMAJ Open. 2022 Feb 8;10(1):E90-E99. doi: 10.9778/cmajo.20210243. Print 2022 Jan-Mar.
citation: McRae AD, Hohl CM, Rosychuk R, Vatanpour S, Ghaderi G, Archambault PM, Brooks SC, Cheng I, Davis P, Hayward J, Lang E, Ohle R, Rowe B, Welsford M, Yadav K, Morrison LJ, Perry J; Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) investigators for the Network of Canadian Emergency Researchers and the Canadian Critical Care Trials Group. CCEDRRN COVID-19 Infection Score (CCIS): development and validation in a Canadian cohort of a clinical risk score to predict SARS-CoV-2 infection in patients presenting to the emergency department with suspected COVID-19. BMJ Open. 2021 Dec 2;11(12):e055832. doi: 10.1136/bmjopen-2021-055832.
citation: Hohl CM, Rosychuk RJ, McRae AD, Brooks SC, Archambault P, Fok PT, Davis P, Jelic T, Turner JP, Rowe BH, Mercier E, Cheng I, Taylor J, Daoust R, Ohle R, Andolfatto G, Atzema C, Hayward J, Khangura JK, Landes M, Lang E, Martin I, Mohindra R, Ting DK, Vaillancourt S, Welsford M, Brar B, Dahn T, Wiemer H, Yadav K, Yan JW, Stachura M, McGavin C, Perry JJ, Morrison LJ; Canadian COVID-19 Emergency Department Rapid Response Network investigators and for the Network of Canadian Emergency Researchers and the Canadian Critical Care Trials Group. Development of the Canadian COVID-19 Emergency Department Rapid Response Network population-based registry: a methodology study. CMAJ Open. 2021 Mar 17;9(1):E261-E270. doi: 10.9778/cmajo.20200290. Print 2021 Jan-Mar.