SaRS-Cov-2 Antibodies Following Exposure to Coronavirus Disease 2019 (COVID-19) and/or Vaccination in Nursing Homes

July 18, 2022 updated by: Pr Athanase BENETOS, Central Hospital, Nancy, France

SaRS-Cov-2 Antibodies Following Exposure to COVID-19 and/or Vaccination in Nursing Homes

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1293

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • US And Canada Only
      • Vandoeuvre les Nancy, US And Canada Only, France, 54500
        • CHRU de Nancy, Université de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Residents in Nursing homes
Diagnostic test: SARS-CoV-2 antibodies
Analysis of the results of the serological response to COVID-19 and/or Vaccine
Health professionals in Nursing homes
Diagnostic test: SARS-CoV-2 antibodies
Analysis of the results of the serological response to COVID-19 and/or Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of SARS-COV-2 antibodies
Time Frame: Through study completion average 6 months Retrospective analysis
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2021

Primary Completion (Actual)

May 15, 2022

Study Completion (Actual)

May 15, 2022

Study Registration Dates

First Submitted

June 26, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHPAD-COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The database can be used by other groups but only for academic purposes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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