NCT04964024

Brief Summary

Presence of SaRS-Cov-2 antibodies following exposure to Coronavirus Disease 2019 (COVID-19) and/or vaccination is a major indicator of immunization. Few data exit about serology response in nursing homes (NHs), i.e. in the most vulnerable population for developing severe forms of the disease. Residents and health professionals in 9 nursing homes (NHs) with SaRS-Cov-2 antibodies detection after exposure (either COVID-19 or vaccine) All biological tests were performed in the frame of the standard care of residents and health professionals and all participants did not express opposition for using anonymously their data for the purpose of this academic analysis. In addition all Directors and Physicians of these NHs accepted to participate in this study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,293

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 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

First Submitted

Initial submission to the registry

June 26, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 15, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

June 26, 2021

Last Update Submit

July 18, 2022

Conditions

Keywords

SARS-CoV-2AntibodiesVaccinationNursing Homes

Outcome Measures

Primary Outcomes (1)

  • Levels of SARS-COV-2 antibodies

    Study of the SARS-COV-2 antibodies according to the history of COVID-19 and vaccinal status in Nursing Home residents and in health professionals

    Through study completion average 6 months Retrospective analysis

Study Arms (2)

Residents in Nursing homes

Diagnostic Test: SARS-CoV-2 antibodies

Health professionals in Nursing homes

Diagnostic Test: SARS-CoV-2 antibodies

Interventions

SARS-CoV-2 antibodiesDIAGNOSTIC_TEST

Analysis of the results of the serological response to COVID-19 and/or Vaccine

Health professionals in Nursing homesResidents in Nursing homes

Eligibility Criteria

Age20 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of the 9 Nursing Homes that participate in this study Health professionals working these Nursing Homes

You may qualify if:

  • For Residents:
  • Living in one of the 9 Nursing Homes that participate in this study
  • Having a SARS-COV-2 post vaccination serology.
  • Having no objection for using the results of the serology for the purpose of this analysis
  • For Health Professionals:
  • Working in one of the 9 Nursing Homes that participate in this study,
  • Having a SARS-COV-2 post vaccination serology.
  • Having no objection for using the results of the serology for the purpose of this analysis

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy, Université de Lorraine

Vandœuvre-lès-Nancy, US and Canada Only, 54500, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Athanase Benetos, Clinical Professor, Head of the Dpt of Geriatrics

Study Record Dates

First Submitted

June 26, 2021

First Posted

July 15, 2021

Study Start

July 15, 2021

Primary Completion

May 15, 2022

Study Completion

May 15, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations