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NCT04563650 Clinical Trial

COVID-19 Serology and Immunosenescence

Covid19 Clinical Trial

— SERO-CoV-OLD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04563650
Other study ID # PI2020_843_0079
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 18, 2020
Est. completion date November 2024

Study information
Verified date April 2024
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 98
Est. completion date November 2024
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary titers of COVID-19 neutralising antibodies day 0
Primary titers of COVID-19 neutralising antibodies at 3 months
Primary titers of COVID-19 neutralising antibodies at 6 months
Primary titers of COVID-19 neutralising antibodies at 9 months
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