COVID-19 Serology and Immunosenescence

NCT04563650 | Active Not Recruiting

• 1 other identifier: PI2020_843_0079
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Geriatric Medicine; Seroconversion; Immunosenescence

Keywords

Covid19; geriatric medicine; seroconversion; immunosenescence

Outcome Measures

Primary Outcomes (4)

• titers of COVID-19 neutralising antibodies

  day 0

• titers of COVID-19 neutralising antibodies

  at 3 months

• titers of COVID-19 neutralising antibodies

  at 6 months

• titers of COVID-19 neutralising antibodies

  at 9 months

Study Arms (2)

COVID-19 positive resident

EXPERIMENTAL

Biological: blood sample

COVID-19 negative resident

ACTIVE COMPARATOR

Biological: blood sample

Interventions

blood sample BIOLOGICAL

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

COVID-19 negative resident; COVID-19 positive resident

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

COVID-19; HIV Seropositivity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: September 18, 2020
• Primary Completion: May 1, 2021
• Study Completion: November 1, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)