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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04702945
Other study ID # H20-01015
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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