NCT04702945

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

50 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

January 6, 2021

Last Update Submit

January 7, 2021

Conditions

Keywords

CoronavirusInfectious diseasesRegistry

Outcome Measures

Primary Outcomes (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.

    14 days

Secondary Outcomes (7)

  • Hospital admission

    30 days

  • Mechanical ventilation

    30 days

  • Emergency department revisits

    30 days

  • Hospital re-admissions

    30 days

  • 30 day mortality

    30 days

  • +2 more secondary outcomes

Study Arms (1)

Registry participants

Patients presenting to participating emergency departments with suspected and or confirmed COVID-19.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (50)

Foothills Medical Centre

Calgary, Alberta, Canada

RECRUITING

Peter Lougheed Centre

Calgary, Alberta, Canada

RECRUITING

Rockyview General Hospital

Calgary, Alberta, Canada

RECRUITING

South Health Campus

Calgary, Alberta, Canada

RECRUITING

Northeast Community Health Centre

Edmonton, Alberta, Canada

RECRUITING

Royal Alexandra Hospital

Edmonton, Alberta, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, Canada

RECRUITING

Abbotsford Regional Hospital

Abbotsford, British Columbia, Canada

RECRUITING

Royal Inland Hospital

Kamloops, British Columbia, Canada

RECRUITING

Kelowna General Hospital

Kelowna, British Columbia, Canada

RECRUITING

Royal Columbian Hospital

New Westminster, British Columbia, Canada

RECRUITING

Lions Gate Hospital

North Vancouver, British Columbia, Canada

RECRUITING

Eagle Ridge Hospital

Port Moody, British Columbia, Canada

RECRUITING

Surrey Memorial Hospital

Surrey, British Columbia, Canada

RECRUITING

Mount Saint Joseph Hospital

Vancouver, British Columbia, Canada

RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, Canada

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, Canada

RECRUITING

Saint John Regional Hospital

Saint John, New Brunswick, Canada

RECRUITING

Dartmouth General Hospital

Dartmouth, Nova Scotia, Canada

RECRUITING

Halifax Infirmary

Halifax, Nova Scotia, Canada

RECRUITING

Cobequid Community Health Centre

Lower Sackville, Nova Scotia, Canada

RECRUITING

Hants Community Hospital

Windsor, Nova Scotia, Canada

RECRUITING

Health Science North

Greater Sudbury, Ontario, Canada

RECRUITING

Hamilton General Hospital

Hamilton, Ontario, Canada

RECRUITING

Juravinski Hospital

Hamilton, Ontario, Canada

RECRUITING

Hotel Dieu Hospital

Kingston, Ontario, Canada

RECRUITING

Kingston General Hospital

Kingston, Ontario, Canada

RECRUITING

London Health Sciences Centre (University Hospital)

London, Ontario, Canada

RECRUITING

London Health Sciences Centre (Victoria Hospital)

London, Ontario, Canada

RECRUITING

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, Canada

RECRUITING

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

RECRUITING

North York General Hospital

Toronto, Ontario, Canada

RECRUITING

Sunnybrook Hospital

Toronto, Ontario, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, Canada

RECRUITING

Hôtel-Dieu de Lévis

Lévis, Quebec, Canada

RECRUITING

Hôpital du Sacré-Coeur

Montreal, Quebec, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

Montréal General Hospital (MUHC)

Montreal, Quebec, Canada

RECRUITING

Royal Victoria Hospital (MUHC)

Montreal, Quebec, Canada

RECRUITING

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

Québec, Quebec, Canada

RECRUITING

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

Québec, Quebec, Canada

RECRUITING

Hôpital du Saint-Sacrement (CHU de Québec)

Québec, Quebec, Canada

RECRUITING

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

Québec, Quebec, Canada

RECRUITING

Hôtel-Dieu de Québec (CHU de Québec)

Québec, Quebec, Canada

RECRUITING

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada

RECRUITING

Pasqua Hospital

Regina, Saskatchewan, Canada

RECRUITING

Regina General Hospital

Regina, Saskatchewan, Canada

RECRUITING

Royal University

Saskatoon, Saskatchewan, Canada

RECRUITING

Saskatoon City Hospital

Saskatoon, Saskatchewan, Canada

RECRUITING

St Paul's Hospital

Saskatoon, Saskatchewan, Canada

RECRUITING

Related Publications (9)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

COVID-19Coronavirus InfectionsCommunicable Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Corinne M Hohl, MD, MSc

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Corinne M Hohl, MD, MSc

CONTACT

Laurie Morrison, MD,MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 11, 2021

Study Start

March 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

January 11, 2021

Record last verified: 2021-01

Locations