The Canadian COVID-19 Prospective Cohort Study

NCT05125510 | Active Not Recruiting DMC

• 2 other identifiers: 20-5403CTO 2157
• Study Type: observational
• Target: 2,176
• Locations: 1 country
• Sites: 14

Brief Summary

The CANCOV study will be the first Canadian study to provide a comprehensive evaluation of early, and 1-year, outcomes of outpatient and hospitalized COVID-19 survivors and their family caregivers, their varied trajectories and associated clinical risk factors. The overall objectives are to determine short- (in hospital) and longer-term (1, 3, 6 and 12 months post-acute hospital discharge) outcomes COVID-19+ patients across the spectrum of symptom severity, including outpatients and inpatients from GIM and ICU wards and their caregivers, and the clinical, sociodemographic, multi-omic predictors of these outcomes. By leveraging expertise from investigators across disciplines and divisions, this study presents a suite of complementary projects that explore the genetic, transcriptomic, epigenomic and immunologic evaluation of COVID-19 infection across the illness and recovery trajectory during the acute illness and in the context of multidimensional long-term outcomes. As there continues to be need for longer term follow up and research on Long-COVID, this study has added an optional extension to include 2-year, 3-year, 4-year and 5 year outcomes.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Functional Independence Measure (FIM) or acute FIM

  FIM is a measure of self-care, sphincter control, mobility, locomotion, communication, social and cognitive skills that has been validated and standardized in spinal cord and stroke populations. The acuteFIM is a subscale of the FIM and adapted to patients in hospital.

  1 year post diagnosis/admission

Secondary Outcomes (21)

• Functional Independence Measure (FIM) or acute FIM

  1,3 and 6 months post diagnosis/admission

• Six Minute Walking Test (6MWT) with oximetry

  admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.

• Pulmonary Function Testing (spirometry)

  admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.

• Medical Research Council (MRC) Score for Muscle Strength

  admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.

• Medical Outcomes Study Short Form -36 Questionnaire (SF-36)

  admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.

Study Arms (5)

Hospitalized ICU Cohort

COVID-19+ patients over age 16 who are critically ill and admitted to an ICU and/or required mechanical ventilation (MV) in participating hospitals will be invited to participate. Patients who were hospitalized prior to study start up will be invited to participate in CANCOV.

Hospitalized non-ICU Cohort

COVID-19+ patients over age 16 admitted to acute care hospitals, GIM/other wards of participating hospitals will be invited to participate. Patients who were hospitalized prior to this study start up (from January 25, 2020 to study start up) will be invited to participate in this study.

Non-Hospitalized Cohort

Individuals who are community dwelling, over the age of 16, are COVID-19+ and never hospitalized for their COVID-19 infection are included. These individuals may be diagnosed by participating hospital emergency rooms / in-person assessment centres / virtual clinics. In addition, we will include individuals who were diagnosed from January 25, 2020 within 6 months of study start up.

Caregiver Cohort

Up to 500 family caregivers of patients admitted to the GIM wards and ICUs of participating hospitals will be invited to participate.

Antibody Negative/Presumed COVID-19 comparator cohort

Approximately 500 individuals who do not have a positive COVID-19 test (nasal swab, serological antibody assay, etc.) but who have experienced COVID-19 symptoms and have strong epidemiologic links suggesting probable COVID-19 infection (such as household or occupational contacts and close timing of their symptoms to an index case) will be invited to participate.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Canadian general population

You may qualify if:

• Patients
• \> 16 years of age
• COVID-19+ test
• Antibody Negative/Presumed COVID-19 comparator cohort
• \> 16 years of age
• NO COVID-19+ test (either by nasal swab or antibody)
• Experienced symptoms
• Strong epidemiologic links suggesting probable COVID-19 infection (such as household or occupational contacts and close timing of their symptoms to an index case.
• Caregiver:
• \. Family caregivers of hospitalized COVID-19+ patients who are participating in the study. Family caregivers are defined as the family member or friend who is responsible for providing and/or coordinating all the COVID-19 survivors' post-hospital care without financial compensation. They will be included if they are able to read and speak English and are over the age of 18 years.

You may not qualify if:

• Anticipated death or withdrawal of life sustaining treatment within 48 hours.
• Catastrophic neurological injury in the opinion of the attending physician (e.g. Grade V SAH or massive CVA).
• Patient unlikely to comply with follow-up.
• Physician refusal (only for hospitalized patients).
• Patient or SDM (substitute decision maker) refuses consent.
• No next of kin or SDM available (if patient unable to provide consent).

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Unity Health: collaborator
• The Hospital for Sick Children: collaborator
• University of Toronto: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Frailty Network: collaborator

Study Sites (14)

Alberta Health Services

Calgary, Alberta, Canada

Location

Providence Healthcare

Vancouver, British Columbia, Canada

Location

Health Sciences Centre and St. Boniface Hospital and Grace Hospital

Winnipeg, Manitoba, Canada

Location

William Osler Health System

Etobicoke, Ontario, M9V 1R8, Canada

Location

St Joseph's Health Centre

Hamilton, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Unity Health (St Michaels Health Centre_

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

University Health Network, Osteoporosis Department

Toronto, Ontario, M5G 2C4, Canada

Location

Hospital for Sick Children

Toronto, Ontario, Canada

Location

Michael Garron Hospital

Toronto, Ontario, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Montreal Jewish General

Montreal, Quebec, Canada

Location

University of Sherbrooke

Sherbrooke, Quebec, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

We are collecting, DNA, RNA, PBMCs, buffy coat, serum, plasma

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: November 18, 2021
• Study Start: June 17, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

CA (14)