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

Primary Purpose

Covid19, Geriatric Medicine, Seroconversion

Status

Active

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

blood sample

About this trial

This is an interventional screening trial for Covid19 focused on measuring Covid19, geriatric medicine, seroconversion, immunosenescence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Amiens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

COVID-19 positive resident

COVID-19 negative resident

Arm Description

Outcomes

Primary Outcome Measures

titers of COVID-19 neutralising antibodies

Secondary Outcome Measures

Full Information

NCT ID

NCT04563650

First Posted

September 18, 2020

Last Updated

February 7, 2023

Sponsor

Centre Hospitalier Universitaire, Amiens

1. Study Identification

Unique Protocol Identification Number

NCT04563650

Brief Title

COVID-19 Serology and Immunosenescence

Acronym

SERO-CoV-OLD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 18, 2020 (Actual)

Primary Completion Date

May 1, 2021 (Actual)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, Geriatric Medicine, Seroconversion, Immunosenescence

Keywords

Covid19, geriatric medicine, seroconversion, immunosenescence

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COVID-19 positive resident

Arm Type

Experimental

Arm Title

COVID-19 negative resident

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

blood sample

Intervention Description

Sample collection of 4 to 10 tubes of whole blood will be done according to centre Saint-Victor's protocol.

Primary Outcome Measure Information:

Title

titers of COVID-19 neutralising antibodies

Time Frame

day 0

Title

titers of COVID-19 neutralising antibodies

Time Frame

at 3 months

Title

titers of COVID-19 neutralising antibodies

Time Frame

at 6 months

Title

titers of COVID-19 neutralising antibodies

Time Frame

at 9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

CHU Amiens

City

Amiens

ZIP/Postal Code

80480

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

COVID-19 Serology and Immunosenescence

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