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Completed

NCT Number: NCT04900376

Evaluation of Covid-19 Vaccination in Elderly Subjects in Retirement Home (EHPAD) and Long-term Care Units (USLD) in Ile-de-France

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.

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Key information

Conditions

Reside Either in Retirement Home or Long-term Care Units Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Geriatric Department, Broca Hospital

Paris, IIe-de-France, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Other outcomes

  1. Carrying out adjustment analyzes by multivariate logistic regressions on confounding factors

    Time frame: 3 months

  2. Performing propensity score analyzes to balance the vaccinated and unvaccinated groups

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Gérond'if

Other

Registry information

Acronym: COGEVAX

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 25, 2021
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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