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Covid-19CCEDRRNNCT04702945

Canadian COVID-19 Emergency Department Registry

An observational study of Covid-19, run by University of British Columbia at 50 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Covid-19
How many people
200,000 participants
Where
50 sitesCanada
Study dates
1 Mar 2020to 31 Dec 2023
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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)

Trial locations and contacts

50 sites in 1 country.

Corinne M Hohl, MD, MSc contact

604-875-4111

corinne.hohl@ubc.ca

50 sites in 1 country

Canada50 sites, 50 recruiting
  • Abbotsford Regional Hospital

    Abbotsford British Columbia, British Columbia

    Recruiting
  • Foothills Medical Centre

    Calgary, Alberta

    Recruiting
  • Peter Lougheed Centre

    Calgary, Alberta

    Recruiting
  • Rockyview General Hospital

    Calgary, Alberta

    Recruiting
  • South Health Campus

    Calgary, Alberta

    Recruiting
  • Dartmouth General Hospital

    Dartmouth, Nova Scotia

    Recruiting
  • Northeast Community Health Centre

    Edmonton, Alberta

    Recruiting
  • Royal Alexandra Hospital

    Edmonton, Alberta

    Recruiting
  • University of Alberta Hospital

    Edmonton, Alberta

    Recruiting
  • Health Science North

    Greater Sudbury, Ontario

    Recruiting
  • Halifax Infirmary

    Halifax, Nova Scotia

    Recruiting
  • Hamilton General Hospital

    Hamilton, Ontario

    Recruiting
  • Juravinski Hospital

    Hamilton, Ontario

    Recruiting
  • Royal Inland Hospital

    Kamloops, British Columbia

    Recruiting
  • Kelowna General Hospital

    Kelowna, British Columbia

    Recruiting
  • Hotel Dieu Hospital

    Kingston, Ontario

    Recruiting
  • Kingston General Hospital

    Kingston, Ontario

    Recruiting
  • Hôtel-Dieu de Lévis

    Lévis, Quebec

    Recruiting
  • London Health Sciences Centre (University Hospital)

    London, Ontario

    Recruiting
  • London Health Sciences Centre (Victoria Hospital)

    London, Ontario

    Recruiting
  • Cobequid Community Health Centre

    Lower Sackville, Nova Scotia

    Recruiting
  • Hôpital du Sacré-Coeur

    Montreal, Quebec

    Recruiting
  • Jewish General Hospital

    Montreal, Quebec

    Recruiting
  • Montréal General Hospital (MUHC)

    Montreal, Quebec

    Recruiting
  • Royal Victoria Hospital (MUHC)

    Montreal, Quebec

    Recruiting
  • Royal Columbian Hospital

    New Westminster, British Columbia

    Recruiting
  • Lions Gate Hospital

    North Vancouver, British Columbia

    Recruiting
  • The Ottawa Hospital - Civic Campus

    Ottawa, Ontario

    Recruiting
  • The Ottawa Hospital - General Campus

    Ottawa, Ontario

    Recruiting
  • Eagle Ridge Hospital

    Port Moody, British Columbia

    Recruiting
  • Centre Hospitalier de l'Université Laval (CHU de Québec)

    Québec, Quebec

    Recruiting
  • Hôpital de l'Enfant-Jésus (CHU de Québec)

    Québec, Quebec

    Recruiting
  • Hôpital du Saint-Sacrement (CHU de Québec)

    Québec, Quebec

    Recruiting
  • Hôpital Saint-François d'Assise (CHU de Québec)

    Québec, Quebec

    Recruiting
  • Hôtel-Dieu de Québec (CHU de Québec)

    Québec, Quebec

    Recruiting
  • Institut universitaire de cardiologie et de pneumologie de Québec

    Québec, Quebec

    Recruiting
  • Pasqua Hospital

    Regina, Saskatchewan

    Recruiting
  • Regina General Hospital

    Regina, Saskatchewan

    Recruiting
  • Saint John Regional Hospital

    Saint John, New Brunswick

    Recruiting
  • Royal University

    Saskatoon, Saskatchewan

    Recruiting
  • Saskatoon City Hospital

    Saskatoon, Saskatchewan

    Recruiting
  • St Paul's Hospital

    Saskatoon, Saskatchewan

    Recruiting
  • Surrey Memorial Hospital

    Surrey, British Columbia

    Recruiting
  • North York General Hospital

    Toronto, Ontario

    Recruiting
  • Sunnybrook Hospital

    Toronto, Ontario

    Recruiting
  • Toronto Western Hospital

    Toronto, Ontario

    Recruiting
  • Mount Saint Joseph Hospital

    Vancouver, British Columbia

    Recruiting
  • St. Paul's Hospital

    Vancouver, British Columbia

    Recruiting
  • Vancouver General Hospital

    Vancouver, British Columbia

    Recruiting
  • Hants Community Hospital

    Windsor, Nova Scotia

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Covid-19
Keywords
Coronavirus, Infectious diseases, Registry
Medical subject headings
COVID-19, Coronavirus Infections, Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04702945
Study groupRoleWhat they receive
Registry participantsPatients presenting to participating emergency departments with suspected and or confirmed COVID-19.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 14 days

Secondary outcomes (7)
  1. Hospital admission

    Any hospital admission within 30 days of index emergency department visit captured in medical chart.

    Measured: 30 days

  2. Mechanical ventilation

    Any mechanical ventilation during any hospital visit within 30 days of index emergency department visit captured in medical chart.

    Measured: 30 days

  3. Emergency department revisits

    Any emergency department revisits within 30 days of index emergency department visit captured in medical chart.

    Measured: 30 days

  4. Hospital re-admissions

    Any hospital re-admissions within 30 days of index emergency department visit date captured in medical chart.

    Measured: 30 days

  5. 30 day mortality

    Any death captured within 30 days of index emergency department visit captured by medical charts.

    Measured: 30 days

  6. 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.

    Measured: 30 days

  7. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2021
  2. Study start1 Mar 2020
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
200,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04702945
Sponsor's protocol ID
H20-01015
Acronym
CCEDRRN
Status last verified
Jan 2021
First submitted
6 Jan 2021
Last updated
11 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rosychuk RJ, Khangura JK, Ortiz SS, Cheng I, Bielska IA, Yan J, Morrison LJ, Hayward J, Grant L, Hohl CM; Canadian COVID-19 Rapid Response Network (CCEDRRN) for the Network of Canadian Emergency Researchers (NCER). Characteristics and outcomes of patients with COVID-19 who return to the emergency department: a multicentre observational study by the Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN). Emerg Med J. 2024 Mar 21;41(4):210-217. doi: 10.1136/emermed-2023-213277.

    PubMed 38365437
  • Hohl CM, Cragg A, Purssell E, McAlister FA, Ting DK, Scheuermeyer F, Stachura M, Grant L, Taylor J, Kanu J, Hau JP, Cheng I, Atzema CL, Bola R, Morrison LJ, Landes M, Perry JJ, Rosychuk RJ; Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) investigators for the Network of Canadian Emergency Researchers; Canadian Critical Care Trials Group. Comparing methods to classify admitted patients with SARS-CoV-2 as admitted for COVID-19 versus with incidental SARS-CoV-2: A cohort study. PLoS One. 2023 Sep 26;18(9):e0291580. doi: 10.1371/journal.pone.0291580. eCollection 2023.

    PubMed 37751455
  • Archambault PM, Rosychuk RJ, Audet M, Bola R, Vatanpour S, Brooks SC, Daoust R, Clark G, Grant L, Vaillancourt S, Welsford M, Morrison LJ, Hohl CM; Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) investigators; Network of Canadian Emergency Researchers; Canadian Critical Care Trials Group. Accuracy of Self-Reported COVID-19 Vaccination Status Compared With a Public Health Vaccination Registry in Quebec: Observational Diagnostic Study. JMIR Public Health Surveill. 2023 Jun 16;9:e44465. doi: 10.2196/44465.

    PubMed 37327046
  • Lin K, Xu K, Daoust R, Taylor J, Rosychuk RJ, Hau JP, Davis P, Clark G, McRae AD, Hohl CM; Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) investigators for the Network of Canadian Emergency Researchers, the Canadian Critical Care Trials Group. Prognostic association between d-dimer thresholds and 30-day pulmonary embolism diagnosis among emergency department patients with suspected SARS-CoV-2 infection: a Canadian COVID-19 Emergency Department Rapid Response Network study. CJEM. 2023 Feb;25(2):134-142. doi: 10.1007/s43678-022-00440-8. Epub 2023 Jan 10.

    PubMed 36624252
  • 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.

    PubMed 35948378
  • 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.

    PubMed 35362857
  • 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.

    PubMed 35135824
  • 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.

    PubMed 34857584
  • 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.

    PubMed 33731427

Questions about this trial

What is this clinical trial studying?

An observational study of Covid-19, run by University of British Columbia at 50 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Corinne M Hohl, MD, MSc (604-875-4111, corinne.hohl@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed COVID-19 diagnosis (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04702945, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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