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Immune Response of Asymptomatic EHPAD Employees Infected With COVID-19 (SERASYMPTO)

Primary Purpose

COVID-19

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
serology
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for COVID-19 focused on measuring EHPAD employees, COVID-19, asymptomatic, humoral response

Eligibility Criteria

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

  • Common inclusion criteria:

    • Age ≥ 18.
    • Health care employees working in the EHPAD who consulted in the Hotel Dieu Hospital
    • Affiliated with a health insurance
    • Informed information and consent

  • Inclusion Criteria for Cases (asymptomatic COVID-19 patients) :

    • Health care workers screened SARS-Cov-2 positive for NASopharyngeal swaths during screening campaigns for EHPAD staff.
    • Having carried out a follow-up serology (M1 and M2) within the Hotel Dieu.
    • Having never developed symptoms of COVID-19 or have developed some symptoms undetected before screening: fever, transient fatigue, rhinorrhea, symptoms that may be mistaken for a common winter cold (no respiratory symptoms or prolonged fever)

  • Inclusion criteria for controls (symptomatic COVID-19 patients) :

    • Health care workers tested positive for polymerase chain reaction assay (PCR) SARS-Cov-2 during screening campaigns for EHPAD staff at the Hotel Dieu.
    • Having carried out a follow-up serology (M1 and M2) within the Hotel Dieu.

COVID-19 symptoms defined by:

  • At least two major signs of COVID-19 among: > fever, cough, chest tightness, bilateral pneumonia, anosmia, loss of taste.
  • or a major sign and three minor signs among: headache, severe fatigue, diarrhea, odynophagia, rhinorrhea, suggestive skin signs.

It is part of the database of the virology department of Cochin Hospital (in case of failure to recruit health care workers in the EHPADs).

*Exclusion criteria :

  • Refuse to participate or inability to obtain informed consent.
  • under guardianship, curators
  • negative SARS-COV-2 PCR
  • Pregnancy

Sites / Locations

  • HOTEL DIEU Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Cases

Controls

Arm Description

SARS-Cov-2 asymptomatic nursing homes employees

cohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital.

Outcomes

Primary Outcome Measures

rate of positive IgG serology
positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees

Secondary Outcome Measures

rate of positive IgG serology
positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees
rate of positive immunoglobulin M (IgM) serology
positive IgM SARS-Cov-2 serology after infection of asymptomatic employees
rate of neutralizing antibodies
concentration of neutralizing antibodies
questionnaire
Associated factors with the presence of antibodies
re infection
of asymptomatic patients with SARS-Cov-2

Full Information

First Posted
November 19, 2020
Last Updated
October 24, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut Pasteur
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1. Study Identification

Unique Protocol Identification Number
NCT05128656
Brief Title
Immune Response of Asymptomatic EHPAD Employees Infected With COVID-19
Acronym
SERASYMPTO
Official Title
Kinetic of Humoral Immune Response of Asymptomatic Nursing Homes (EHPAD) Employees Infected With Severe Acute Respiratory Syndrome Coronavirus : a Case Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Authorization denied by Ethical Comitee
Study Start Date
June 18, 2022 (Actual)
Primary Completion Date
June 18, 2022 (Actual)
Study Completion Date
June 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut Pasteur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris France (EHPAD), where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2). Few data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection. The purpose of the study is to determine whether these asymptomatic persons develop a humoral immune response, whether this immune response is durable and whether it is protective against the risk of reinfection
Detailed Description
The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris, France, where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of SARS-Cov-2. Few data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection. The main objective of this study is to describe the SARS-Cov-2 asymptomatic employees with positive immunoglobulin G (igG) serology at month 1-2 post infection. Secondary objectives are To describe the proportion of asymptomatic persons with SARS-Cov-2 antibodies month 3 and 6 post infection To compare the proportion of persons with SARS-Cov-2 antibodies between asymptomatic and asymptomatic carriers at M1-2 post infection, M3 and M6 post infection To determine the factors associated with the appearance of antibodies ( viral load, age, sex, previous history, habitus..) To study the neutralizing capacities and immune-profiling of SARS-Cov-2 antibodies in vitro To evaluate the occurrence of Coronavirus Disease 2019 (COVID-19) reinfections in asymptomatic carriers during the second wave. The design will be a case control study between Cases: SARS-Cov-2 asymptomatic nursing homes employees Controls: cohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
EHPAD employees, COVID-19, asymptomatic, humoral response

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Case control longitudinal study, Interventional minimal risk study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cases
Arm Type
Other
Arm Description
SARS-Cov-2 asymptomatic nursing homes employees
Arm Title
Controls
Arm Type
Other
Arm Description
cohort of patients with a symptomatic COVID-19, preferably recruited in nursing homes or in case of difficulties in the virology service of COCHIN Hospital.
Intervention Type
Other
Intervention Name(s)
serology
Intervention Description
serology at M3 and serology at M6
Primary Outcome Measure Information:
Title
rate of positive IgG serology
Description
positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees
Time Frame
month 1-2 post infection
Secondary Outcome Measure Information:
Title
rate of positive IgG serology
Description
positive IgG (Immunoglobulin G) SARS-Cov-2 serology after infection of asymptomatic employees
Time Frame
month 3-6 post infection
Title
rate of positive immunoglobulin M (IgM) serology
Description
positive IgM SARS-Cov-2 serology after infection of asymptomatic employees
Time Frame
month 1-2-3 and 6 post infection
Title
rate of neutralizing antibodies
Description
concentration of neutralizing antibodies
Time Frame
month 1-2-3 and 6 post infection
Title
questionnaire
Description
Associated factors with the presence of antibodies
Time Frame
month 1-2-3 and 6 post infection
Title
re infection
Description
of asymptomatic patients with SARS-Cov-2
Time Frame
through study completion, an average of 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Common inclusion criteria: Age ≥ 18. Health care employees working in the EHPAD who consulted in the Hotel Dieu Hospital Affiliated with a health insurance Informed information and consent Inclusion Criteria for Cases (asymptomatic COVID-19 patients) : Health care workers screened SARS-Cov-2 positive for NASopharyngeal swaths during screening campaigns for EHPAD staff. Having carried out a follow-up serology (M1 and M2) within the Hotel Dieu. Having never developed symptoms of COVID-19 or have developed some symptoms undetected before screening: fever, transient fatigue, rhinorrhea, symptoms that may be mistaken for a common winter cold (no respiratory symptoms or prolonged fever) Inclusion criteria for controls (symptomatic COVID-19 patients) : Health care workers tested positive for polymerase chain reaction assay (PCR) SARS-Cov-2 during screening campaigns for EHPAD staff at the Hotel Dieu. Having carried out a follow-up serology (M1 and M2) within the Hotel Dieu. COVID-19 symptoms defined by: At least two major signs of COVID-19 among: > fever, cough, chest tightness, bilateral pneumonia, anosmia, loss of taste. or a major sign and three minor signs among: headache, severe fatigue, diarrhea, odynophagia, rhinorrhea, suggestive skin signs. It is part of the database of the virology department of Cochin Hospital (in case of failure to recruit health care workers in the EHPADs). *Exclusion criteria : Refuse to participate or inability to obtain informed consent. under guardianship, curators negative SARS-COV-2 PCR Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Salmon, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOTEL DIEU Hospital
City
Paris
ZIP/Postal Code
75004
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Immune Response of Asymptomatic EHPAD Employees Infected With COVID-19

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