NCT04782427

Brief Summary

The medical charts of all COVID-19 cases (n=1200) from 17 long-term care facilities in Montreal, Canada will be reviewed, to compare patients who survived to patients who did not survive. Through multilevel logistic regression, the risk of death will be estimated for institutional predictors of mortality, while controlling for individual risk factors. Individual covariates include clinical features (age, sex, Charlston comorbidity index, SMAF autonomy score, severity criteria) and medical treatments (IV fluids, anticoagulation, oxygen, regular opiates, corticosteroids). Aggregate covariates include epidemiological data (attack rates, timing of outbreak) and institutional characteristics (number of beds, air exchange per hour, presence of a dedicated COVID-19 unit at the time of outbreak, staff compliance to infection control measures, staff infection rates, understaffing, proportion of semi-private rooms, proportion of wandering wards and other special units).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,197

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2021

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

3 months

First QC Date

March 2, 2021

Last Update Submit

July 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Death

    COVID-19 as a primary or secondary cause of death

    28 days

Interventions

Case of nosocomial infection within the long-term care facility

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Most of the residents living in the long-term care facilities are elderly and frail, with a high prevalence of major neurocognitive disorders and low life expectancy. However, some patients are more robust (e.g. residents of wandering wards) or younger (e.g. residents with heavy neurological or mental health diagnoses).

You may qualify if:

  • Resident of a long-term care facility within the CIUSSS Centre-Sud-de-l'Île-de-Montréal
  • Nosocomial COVID-19 infection diagnosis between March 23rd and July 11th 2020

You may not qualify if:

  • Admission to the long-term care facility after July 11th 2020
  • COVID-19 infection which was not acquired within the long-term care facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIUSSS Centre-Sud-de-l'Île-de-Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

COVID-19DeathVirus DiseasesRespiratory Tract InfectionsCoronavirus InfectionsAlzheimer Disease

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaInfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Sophie Zhang, M.D.

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head physician of long-term care facilities and researcher

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 4, 2021

Study Start

January 1, 2021

Primary Completion

April 13, 2021

Study Completion

May 13, 2021

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

All deidentified information will be shared, except if there are patient confidentiality issues.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
At the time of publication, for 5 years.
Access Criteria
Written request submitted to the principal investigator.

Locations