The Canadian COVID-19 Prospective Cohort Study

  • STATUS
    Recruiting
  • End date
    Dec 26, 2023
  • participants needed
    2500
  • sponsor
    University Health Network, Toronto
Updated on 26 November 2021

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.

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.

Details
Condition COVID19
Clinical Study IdentifierNCT05125510
SponsorUniversity Health Network, Toronto
Last Modified on26 November 2021

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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