Evaluation of Covid-19 Vaccination in Elderly Subjects in Retirement Home (EHPAD) and Long-term Care Units (USLD) in Ile-de-France (COGEVAX)
The main objective of this non-interventional, multi-center study is to compare the incidence of serious health events (death, unscheduled hospitalizations) in subjects vaccinated against Coronavirus with that of unvaccinated subjects, in Retirement Home (EHPAD) and Long-term Care Units (USLD) in Ile-De-France during the same observation period 12-months minimun and up to18 months according vaccinal schedule.
The primary outcome will be the incidence of serious health events (death and unscheduled hospitalizations) in subjects vaccinated against Coronavirus compared to that of unvaccinated subjects.
Study Overview
Status
Detailed Description
This multicenter study is a parallel cohort to the first phase of the vaccination campaign against Coronavirus, in particular for elderly subjects in institutions. All subjects who will not oppose the study will be included and this date will correspond to Day 0.
D0 will correspond to the date of the first vaccine injection for subjects in the vaccine group.
The subjects included will be followed up on D21, D90, M6, 12 months (M12) and up to 18 months in the case of 3rd vaccinal injection
The following data will be collected at inclusion and during follow-up:
- Age, weight, sex, level of autonomy
- Chronic diseases
- Any hospitalizations
- Possible symptoms after vaccination for subjects who choose to be vaccinated
- The fate of the subjects and the evaluation of the immune response
- Hospitalizations and vital status of subjects
Serology data prescribed by doctors as part of routine care will also be collected.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Isabelle Dufour
- Phone Number: +33 (0)185781010
- Email: isabelle.dufour@gerondif.org
Study Contact Backup
- Name: Adrien Besseiche
- Phone Number: +33 (0)185781010
- Email: adrien.besseiche@gerondif.org
Study Locations
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IIe-de-France
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Paris, IIe-de-France, France, 75013
- Recruiting
- Geriatric Department, Broca Hospital
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Contact:
- Olivier Hanon, MD PhD
- Phone Number: +33 (0)144083503
- Email: olivier.hanon@aphp.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subject in Retirement Home (EHPAD) or Long-term Care Units (USLD) during the anti-Coronavivus vaccination period.
- Subject not opposing the study or whose legal representative does not oppose the study.
Exclusion Criteria:
- Subject not affiliated to a social security scheme.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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vaccinated group
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unvaccinated group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessment of the incidence of serious events in subjects vaccinated against CORONAVIRUS compared to those not vaccinated using their number, percentage and 95% confidence interval and methods of survival analysis Kaplan Meier and Cox model
Time Frame: 12 months or 18 months in the case of the 3rd vaccinal injection
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12 months or 18 months in the case of the 3rd vaccinal injection
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessment of the incidence of geriatric syndromes using their number, percentage and 95% confidence interval and survival analysis methods: Kaplan Meier and Cox model
Time Frame: 3 months
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3 months
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Evaluating the Incidence of Organ Decompensations according Their Number, Percentage, and 95% Confidence Interval and Survival Analysis Methods: Kaplan Meier and Cox Model
Time Frame: 6 months
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6 months
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Assessment of the incidence of serious and non-serious side effects using their number, percentage and 95% confidence interval and survival analysis methods: Kaplan Meier and Cox model. Kaplan Meier and Cox model
Time Frame: 3 months
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3 months
|
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Comparison of the incidence of symptomatic and severe coronavirus in vaccinated and unvaccinated subjects using their number, percentage and 95% confidence interval and survival analysis methods: Kaplan Meier and Cox Model. Kaplan Meier and Cox model
Time Frame: 3 months
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3 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Carrying out adjustment analyzes by multivariate logistic regressions on confounding factors
Time Frame: 3 months
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3 months
|
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Performing propensity score analyzes to balance the vaccinated and unvaccinated groups
Time Frame: 3 months
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Olivier Hanon, MD PhD, Geriatric Department, Broca Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021-A00007-34
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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