Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
2176 participants
OBSERVATIONAL
2020-06-17
2027-12-31
Brief Summary
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Detailed Description
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The CANCOV investigator group is conducting a national Canadian COVID-19 Prospective Cohort Study (CANCOV). This will be a multi-centre, one-year follow-up of 1000 COVID-19 patients who are hospitalized in acute care hospitals (those admitted to general internal medicine (GIM) wards, and/or ICUs) and their caregivers, and 1000 non-hospitalized patients (those who were tested positive and asked to isolate at home) in participating centres across Canada. In addition, a cohort of 500-1000 patients who do not have a COVID-19 positive test but who present with a clinical diagnosis of COVID-19 will be included for investigation and comparison. The overall objectives are to determine short- (in hospital, and 2-week outcome for non-hospitalized patients) and longer-term (1, 3, 6 and 12 months post-acute hospital discharge or post diagnosis for outpatients) outcomes in patients and their caregivers, and the clinical, sociodemographic, genetic/ transcriptomic/epigenomic/immunological predictors of these outcomes. Due to patients with 'long-COVID' syndrome, the investigators have added an optional study extension for an additional 48 months, up to 5 years follow up.
By leveraging expertise from investigators across disciplines and divisions, this study presents a suite of complementary projects that explore the genetic, transcriptomic, epigenomic and immunological evaluation of COVID-19 infection across the illness and recovery trajectory in mild as well as acute illness and in the context of multidimensional long-term outcomes. The investigators will access electronic data through the GEMINI network, and explore Artificial Intelligence (AI) analyses and linkages through Institute of Clinical and Evaluative Sciences (ICES) data. This project will contribute new knowledge to outcomes in patients with COVID-19 infections and will inform large-scale public health planning, clinical care, and ongoing resource needs.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Caregiver Cohort
Up to 500 family caregivers of patients admitted to the GIM wards and ICUs of participating hospitals will be invited to participate.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. \> 16 years of age
2. COVID-19+ test
Antibody Negative/Presumed COVID-19 comparator cohort
1. \> 16 years of age
2. NO COVID-19+ test (either by nasal swab or antibody)
3. Experienced symptoms
4. 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:
1\. 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.
Exclusion Criteria
2. Catastrophic neurological injury in the opinion of the attending physician (e.g. Grade V SAH or massive CVA).
3. Patient unlikely to comply with follow-up.
4. Physician refusal (only for hospitalized patients).
5. Patient or SDM (substitute decision maker) refuses consent.
6. No next of kin or SDM available (if patient unable to provide consent).
16 Years
ALL
No
Sponsors
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Unity Health
OTHER
The Hospital for Sick Children
OTHER
University of Toronto
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Canadian Frailty Network
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Locations
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Alberta Health Services
Calgary, Alberta, Canada
Providence Healthcare
Vancouver, British Columbia, Canada
Health Sciences Centre and St. Boniface Hospital and Grace Hospital
Winnipeg, Manitoba, Canada
William Osler Health System
Etobicoke, Ontario, Canada
St Joseph's Health Centre
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Unity Health (St Michaels Health Centre_
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
University Health Network, Osteoporosis Department
Toronto, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Michael Garron Hospital
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Montreal Jewish General
Montreal, Quebec, Canada
University of Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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CTO 2157
Identifier Type: OTHER
Identifier Source: secondary_id
20-5403
Identifier Type: -
Identifier Source: org_study_id
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