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SERO-CoV-OLD: COVID-19 Serology and Immunosenescence

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT04563650
Collaborator
(none)
330
Enrollment
1
Location
2
Arms
13.4
Anticipated Duration (Months)
24.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: blood sample
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
330 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Kinetics of COVID-19-neutralising Antibodies in Patients Residing in EHPAD / USLD: Influence of Immunosenescence
Actual Study Start Date :
Sep 18, 2020
Actual Primary Completion Date :
May 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. titers of COVID-19 neutralising antibodies [day 0]

  2. titers of COVID-19 neutralising antibodies [at 3 months]

  3. titers of COVID-19 neutralising antibodies [at 6 months]

  4. titers of COVID-19 neutralising antibodies [at 9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Amiens France 80480

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT04563650
Other Study ID Numbers:
  • PI2020_843_0079
First Posted:
Sep 24, 2020
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Covid19
geriatric medicine
seroconversion
immunosenescence
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Jul 21, 2021