Overview
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.
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, we have added an optional
study extension for an additional 24 months.
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.
Eligibility
Inclusion Criteria:
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.
Exclusion Criteria:
- 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).