COVID-19 Serology and Immunosenescence (SERO-CoV-OLD)

April 9, 2024 updated by: Centre Hospitalier Universitaire, Amiens

Kinetics of COVID-19-neutralising Antibodies in Patients Residing in EHPAD / USLD: Influence of Immunosenescence

This study aims to determine how long COVID-19 neutralizing antibodies can be detected in an elderly institutionalized population presenting fragility factors.

This study also aims to stratify seroconversion by immunological profiles of the elderly patients residing in the EHPAD. This stratification requires the measurement of immunological marker levels already described in immunosenescence and also involved in the development of certain chronic infectious diseases more common in the elderly population. This analysis will enable the investigators to describe an immunological, clinical and biological profile representing a patient who has developed an immunity against COVID 19. It will also help the investigators to understand the different mechanisms leading to a reduced immune response after a potential administration of a vaccine. Finally, it will help describe the immune profiles of elderly residents who presented with non-severe forms of COVID-19.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

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
      • Amiens, France, 80480
        • CHU Amiens

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Residents of the EHPAD/USLD St Victor of the Amiens CHU who took part in the screening campaign (RT-PCR and serology) organized by the Amiens CHU
  • residents who signed a consent form to participate in the study

Exclusion Criteria:

  • The patient or his legal representative refused to participate in the study
  • Heavily sedated patients

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COVID-19 positive resident
Biological: blood sample
Sample collection of 4 to 10 tubes of whole blood will be done according to centre Saint-Victor's protocol.
Active Comparator: COVID-19 negative resident
Biological: blood sample
Sample collection of 4 to 10 tubes of whole blood will be done according to centre Saint-Victor's protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
titers of COVID-19 neutralising antibodies
Time Frame: day 0
day 0
titers of COVID-19 neutralising antibodies
Time Frame: at 3 months
at 3 months
titers of COVID-19 neutralising antibodies
Time Frame: at 6 months
at 6 months
titers of COVID-19 neutralising antibodies
Time Frame: at 9 months
at 9 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

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)

September 18, 2020

Primary Completion (Actual)

May 1, 2021

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2020_843_0079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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