Canadian COVID-19 Emergency Department Registry

Covid-19 Clinical Trial

— CCEDRRN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04702945
• Other study ID #: H20-01015
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2021
• Source: University of British Columbia
• Contact: Corinne M Hohl, MD, MSc
• Phone: 604-875-4111
• Email: corinne.hohl[@]ubc.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Covid-19
• Emergencies

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Genome British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed COVID-19 diagnosis	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	Hospital admission	Any hospital admission within 30 days of index emergency department visit captured in medical chart.	30 days
Secondary	Mechanical ventilation	Any mechanical ventilation during any hospital visit within 30 days of index emergency department visit captured in medical chart.	30 days
Secondary	Emergency department revisits	Any emergency department revisits within 30 days of index emergency department visit captured in medical chart.	30 days
Secondary	Hospital re-admissions	Any hospital re-admissions within 30 days of index emergency department visit date captured in medical chart.	30 days
Secondary	30 day mortality	Any death captured within 30 days of index emergency department visit captured by medical charts.	30 days
Secondary	Clinical recovery	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
Secondary	Patient quality of life	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