NCT04900376

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

May 22, 2021

Last Update Submit

March 3, 2023

Conditions

Reside Either in Retirement Home or Long-term Care Units

Keywords

Retirement Home (EHPAD)Long-term Care Units (USLD)CoronavirusVaccination

Outcome Measures

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

    12 months or 18 months in the case of the 3rd vaccinal injection

Secondary Outcomes (4)

  • Assessment of the incidence of geriatric syndromes using their number, percentage and 95% confidence interval and survival analysis methods: Kaplan Meier and Cox model

    3 months

  • Evaluating the Incidence of Organ Decompensations according Their Number, Percentage, and 95% Confidence Interval and Survival Analysis Methods: Kaplan Meier and Cox Model

    6 months

  • 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

    3 months

  • 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

    3 months

Other Outcomes (2)

  • Carrying out adjustment analyzes by multivariate logistic regressions on confounding factors

    3 months

  • Performing propensity score analyzes to balance the vaccinated and unvaccinated groups

    3 months

Study Arms (2)

vaccinated group

unvaccinated group

Eligibility Criteria

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

Retirement Home (EHPAD) residents and Long-term Care Units (USLD) patients vaccinated or not against Coronavivus.

You may qualify if:

  • 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.

You may not qualify if:

  • Subject not affiliated to a social security scheme.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Department, Broca Hospital

Paris, IIe-de-France, 75013, France

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Olivier Hanon, MD PhD

    Geriatric Department, Broca hospital

    STUDY CHAIR

Central Study Contacts

Isabelle Dufour

CONTACT

+33 (0)185781010isabelle.dufour@gerondif.org

Adrien Besseiche

CONTACT

+33 (0)185781010adrien.besseiche@gerondif.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2021

First Posted

May 25, 2021

Study Start

February 15, 2021

Primary Completion

December 31, 2022

Study Completion

July 1, 2023

Last Updated

March 6, 2023

Record last verified: 2023-03

Locations

FR(1)