Official Title
The Canadian COVID-19 Prospective Cohort Study
Brief Summary

The CANCOV study will be the first Canadian study to provide a comprehensive evaluationof early, and 1-year, outcomes of outpatient and hospitalized COVID-19 survivors andtheir 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 and12 months post-acute hospital discharge) outcomes COVID-19+ patients across the spectrumof symptom severity, including outpatients and inpatients from GIM and ICU wards andtheir caregivers, and the clinical, sociodemographic, multi-omic predictors of theseoutcomes. 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 theillness and recovery trajectory during the acute illness and in the context ofmultidimensional long-term outcomes. As there continues to be need for longer term followup and research on Long-COVID, this study has added an optional extension to include2-year, 3-year, 4-year and 5 year outcomes.

Detailed Description

In December 2019, a novel coronavirus (COVID-19)-infected pneumonia was identified in
Wuhan, China, and is a current global pandemic. Early studies are emerging, but it is
still unclear what may determine better or worse outcomes for these patients and their
caregivers, and the detailed nature of long-term consequences from this infection.
Current data suggest that 80-85% of patients infected with COVID-19 have mild symptoms
and are not hospitalized. Of those who are hospitalized, 60-80% will be discharged from
hospital after a few days, and 20-40% may require treatment in an intensive care unit
(ICU) and/or mechanical ventilation (approximately 4-6% of all COVID-19 positive
patients). The determining factors of these varied clinical paths are urgently needed and
unknown.

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.

Active, not recruiting
COVID19
Eligibility Criteria

Inclusion Criteria:

Patients

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:

1. Anticipated death or withdrawal of life sustaining treatment within 48 hours.

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).

Eligibility Gender
All
Eligibility Age
Minimum: 16 Years ~ Maximum: N/A
Countries
Canada
Locations

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

Michael Garron Hospital (Toronto East General Hospital)
Toronto, 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

McGill University Health Centre
Montreal, Quebec, Canada

Montreal Jewish General
Montréal, Quebec, Canada

University of Sherbrooke
Sherbrooke, Quebec, Canada

Not Provided

University Health Network, Toronto
NCT Number
MeSH Terms
COVID-19