Clinical trial NCT05125510: The Canadian COVID-19 Prospective Cohort Study
Official title: The Canadian COVID-19 Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Covid19
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Unity Health
name: The Hospital for Sick Children
name: University of Toronto
name: Canadian Institutes of Health Research (CIHR)
name: Canadian Frailty Network
First posted: 2021-11-18
Enrollment: 2176
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Canadian general population

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.

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.

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).

Primary outcomes:
measure: Functional Independence Measure (FIM) or acute FIM
timeFrame: 1 year post diagnosis/admission
Secondary outcomes:
measure: Functional Independence Measure (FIM) or acute FIM
timeFrame: 1,3 and 6 months post diagnosis/admission
measure: Six Minute Walking Test (6MWT) with oximetry
timeFrame: admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Pulmonary Function Testing (spirometry)
timeFrame: admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Medical Research Council (MRC) Score for Muscle Strength
timeFrame: admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Medical Outcomes Study Short Form -36 Questionnaire (SF-36)
timeFrame: admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: General Anxiety Assessment Form (GAD-7)
timeFrame: admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: PCL-5 Trauma Score
timeFrame: admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Connor-Davidson Resiliency Scale (CD-RISC)
timeFrame: admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: BORG Dypsnea scale
timeFrame: admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Clinical Frailty Scale Score (CFS)
timeFrame: admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Rapid Geriatric Assessment
timeFrame: admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Stigma Scale (SS)
timeFrame: admission/diagnosis to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Mortality
timeFrame: admission/diagnosis to 1 year. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Pattern and Cost of Post-hospital discharge Healthcare Utilization (Resources and Costs)
timeFrame: admission/diagnosis to 1,3,6, and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Medical Outcomes Study Social Support Scale (SS)
timeFrame: baseline to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Care-giving Impact Scale (CIS)
timeFrame: baseline to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Care-giving Assistance Scale (CAS)
timeFrame: baseline to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Pearlin's Mastery Scale
timeFrame: baseline to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
measure: Personal Gain Scale
timeFrame: baseline to 1,3,6 and 12 months. Extension 18, 24, 30, 36, 42, 48, 54, 60 months.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Health Services
state: Alberta
city: Vancouver
country: Canada
facility: Providence Healthcare
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Centre and St. Boniface Hospital and Grace Hospital
state: Manitoba
city: Etobicoke
country: Canada
facility: William Osler Health System
state: Ontario
city: Hamilton
country: Canada
facility: St Joseph's Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Michael Garron Hospital (Toronto East General Hospital)
state: Ontario
city: Toronto
country: Canada
facility: Unity Health (St Michaels Health Centre_
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Osteoporosis Department
state: Ontario
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: Montreal Jewish General
state: Quebec
city: Sherbrooke
country: Canada
facility: University of Sherbrooke
state: Quebec
Study officials:
References: