The Canadian COVID-19 Prospective Cohort Study (CANCOV)

University Health Network, Toronto

Status: Active, not recruiting

Conditions: Covid19

Study type: Observational

Funder types: Other

Identifiers

NCT05125510

20-5403

CTO 2157

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,176 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

2,176 participants in 5 patient groups

Hospitalized ICU Cohort

Description:

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

Description:

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

Description:

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

Description:

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

Description:

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.