Covid-19 Clinical Trial
— CCEDRRNOfficial title:
Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) - Population-based Registry of Suspected and Confirmed COVID-19 Cases
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 |
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.
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) |
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 |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Genome British Columbia |
Canada,
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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