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COVID-19 Study of the Serological Response Against the Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV-2) Virus in 2 Types of Employees, Hospital and Non-hospital, at Institute Curie and Institute Pasteur (Curie-O-SA)

Primary Purpose

Volunteers From the Institute Curie and Institute Pasteur Staff Who Are Not Showing Active SARS-CoV-2 Infection

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples (collection of 5 mL of blood in a dry tube)
Nasopharyngeal swabs
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Volunteers From the Institute Curie and Institute Pasteur Staff Who Are Not Showing Active SARS-CoV-2 Infection focused on measuring Adults, Volunteers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Person, adult volunteer outside of any acute infectious episode with SARS-CoV-2* (see paragraph indication), working at the Institute Curie and able to exercise their professional activity on one of the 3 sites of the Institute Curie: Paris, Orsay or Saint Cloud, or on the Campus of the Institute Pasteur.
  2. Person aged 18 or over.
  3. Information and consent of the person to the procedures related to the study (cf. information note / consent).

From November 2020, person having presented at least one of the following criteria since January 2020:

  • A positive diagnostic test for SARS-COV-2 by PCR on a nasopharyngeal sample or antigenic test,
  • A positive SARS-CoV-2 serology,
  • An anosmia or / and an ageusia,
  • A respiratory infection ** associated with digestive signs **

whatever the working methods during confinement * Subjects who are not showing active SARS-CoV-2 infection are considered volunteers at the time of inclusion: people with no clinical signs ** suggestive of SARS-CoV-2 infection at the time of collection or having had an end of symptoms for more than 7 days [1].

** fever, fatigue, cough, shortness of breath, difficulty to breath, loss of taste or smell, headache, body aches, conjunctivitis or cold, digestive problems (vomiting, diarrhea), whether or not the signs led to sick leave, treatment and / or hospitalization [2].

Exclusion Criteria:

  • Declaration by the subject of signs suggestive of Coronavirus Infectious Disease 2019 (COVID-19) infection with SARS-CoV-2 in progress or for which the end of symptoms dates from less than 7 days
  • Inability to submit to study monitoring for geographic, social or psychological reasons

Sites / Locations

  • Institut Curie
  • Institut Pasteur

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Subjects who are not showing active SARS-Cov2 infection

Arm Description

Outcomes

Primary Outcome Measures

Antibodies against the SARS-CoV-2 virus in serum at inclusion
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Antibodies against the SARS-CoV-2 virus in serum at 1 month
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Antibodies against the SARS-CoV-2 virus in serum at 3 months
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Antibodies against the SARS-CoV-2 virus in serum at 6 months
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Antibodies against the SARS-CoV-2 virus in serum at 12 months
Detection of antibodies against the SARS-CoV-2 virus with serological tests

Secondary Outcome Measures

Comparative performance of anti-SARS-CoV-2 antibody detection techniques
Comparative performance of anti-SARS-CoV-2 antibody detection techniques (sensitivity and specificity of serological tests)
Prevalence of immune subjects for SARS-CoV-2
Prevalence of immune subjects for SARS-CoV-2 in a well-defined active healthy population, working at the hospital or not, leading to variable exposure levels
Nature and quantity of anti-SARS-CoV-2 antibodies
Nature and quantity of anti-SARS-CoV-2 antibodies: ImmunoglobulinM, ImmunoglobulinG and ImmunoglobulinA)
Evolution of the different antibodies against the SARS-CoV-2 virus over time.
The analysis of the evolution of serology results over time will be done by a mixed model taking into account the repeated framework of the data of a subject
Prevalence of Anti-covid IgA response in the nasal mucosa
Prevalence of Anti-covid IgA in volonteers RT/PCR+ and/or presence of antibodies at the 95 % threshold and/or COVID symptoms

Full Information

First Posted
April 27, 2020
Last Updated
May 16, 2022
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT04369066
Brief Title
COVID-19 Study of the Serological Response Against the Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV-2) Virus in 2 Types of Employees, Hospital and Non-hospital, at Institute Curie and Institute Pasteur
Acronym
Curie-O-SA
Official Title
COVID-19 Study of the Serological Response Against the SARS-CoV-2 Virus in 2 Types of Employees, Hospital and Non-hospital, at Institute Curie and Institute Pasteur
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 28, 2020 (Actual)
Primary Completion Date
January 6, 2022 (Actual)
Study Completion Date
May 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie

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
This research proposes to study a large healthy population active for the presence of antibodies directed against the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus and this over time. After verification of the inclusion criteria and information by the coordinating investigative doctor, the volunteers sign a written consent. A nurse will take blood samples under safe conditions compatible with the pandemic period and while respecting the protection of the volunteer's personal data. The blood samples will be taken at 4 times for Institute Curie and Institute Pasteur: T0 (day of inclusion), between 6 weeks and 3 months ,6 months and 12 months post-inclusion. Each blood sample consists of a collection of 5 mL of blood in a dry tube. The serum samples will be extracted and collected prospectively from the blood samples. The nasopharyngeal swabs will be performed at 3 times: , between 6 weeks and 3 months, 6 months and 12 months post-inclusion for Institute Curie staff who have had at least one of the following four criteria on the sample or questionnaire carried out at T0: have had RT-PCR+ and/or presence of antibodies at the 95% threshold and/or anosmia/ageusia and/or digestive syndrome with associated respiratory signs. In case of infection between sampling times, if the volunteer meets one of the four criteria above, a nasopharyngeal swab will be performed during the following visits. The nasopharyngeal swab shall also be proposed to volunteers not meeting the 4 above listed criteria in order to have a control group (about 100 volunteers) for future statistical analyses. If the volunteers accept, naso-pharyngeal swab shall be performed between 6 weeks and 3 months, 6 months and 12 months after inclusion. For volunteers already included at Institute Curie : in case of proved (RT-PCR+ or antigenic +) or very likely (anosmia and/or ageusia, and/or digestive syndrome with associated respiratory signs) between 2 sampling times already planned in the flow chart, blood samples and nasopharyngeal swabs shall be performed. Those shall be performed if time since last planned sampling(s) has been more than 3 weeks or if time until next sampling(s) is more than 3 weeks. The blood samplings and nasopharyngeal swabs will be performed at 4 times for Institute Pasteur personnel: at T0 (inclusion day), between 6 weeks and 3 months, at 6 months and 12 months post-inclusion

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Volunteers From the Institute Curie and Institute Pasteur Staff Who Are Not Showing Active SARS-CoV-2 Infection
Keywords
Adults, Volunteers

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1971 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects who are not showing active SARS-Cov2 infection
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood samples (collection of 5 mL of blood in a dry tube)
Intervention Description
A nurse will take blood samples under safe conditions compatible with the pandemic period and while respecting the protection of the volunteer's personal data. The blood samples will be taken at 4 times for Institute Curie and Institute Pasteur: T0, between 6 weeks and 3 months ,6 months and 12 months post-inclusion. For volunteers already included at Institute Curie : in case of proved (RT-PCR+ or antigenic +) or very likely (anosmia and/or ageusia, and/or digestive syndrome with associated respiratory signs) between 2 sampling times already planned in the flow chart, blood samples shall be performed, if time since last planned sampling(s) has been more than 3 weeks or if time until next sampling(s) is more than 3 weeks. The serum samples will be extracted and collected prospectively from the blood samples. For each blood sample, a sample number will be assigned by the laboratory management system of the Department of Biology at Institut Curie.
Intervention Type
Diagnostic Test
Intervention Name(s)
Nasopharyngeal swabs
Intervention Description
The nasopharyngeal swabs will be performed between 6 weeks and 3 months, 6 months and 12 months post-inclusion for Institute Curie staff with at least one of the following criteria: have had RT-PCR+, and/or presence of antibodies at the 95% threshold, and/or anosmia/ageusia, and/or digestive syndrome with associated respiratory signs. The nasopharyngeal swab shall also be proposed to volunteers not meeting the above listed criteria to have a control group (about 100 volunteers). For volunteers already included at Institute Curie : in case of proved (RT-PCR+ or antigenic +) or very likely (anosmia and/or ageusia, and/or digestive syndrome with associated respiratory signs) infection between 2 sampling times, nasopharyngeal swabs shall be performed if time since last planned sampling(s) has been more than 3 weeks or if time until next sampling(s) is more than 3 weeks. The nasopharyngeal swabs will be performed at T0 for Institute Pasteur staff so 4 times in total.
Primary Outcome Measure Information:
Title
Antibodies against the SARS-CoV-2 virus in serum at inclusion
Description
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Time Frame
1 day
Title
Antibodies against the SARS-CoV-2 virus in serum at 1 month
Description
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Time Frame
1 month
Title
Antibodies against the SARS-CoV-2 virus in serum at 3 months
Description
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Time Frame
3 months
Title
Antibodies against the SARS-CoV-2 virus in serum at 6 months
Description
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Time Frame
6 months
Title
Antibodies against the SARS-CoV-2 virus in serum at 12 months
Description
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Comparative performance of anti-SARS-CoV-2 antibody detection techniques
Description
Comparative performance of anti-SARS-CoV-2 antibody detection techniques (sensitivity and specificity of serological tests)
Time Frame
9 months
Title
Prevalence of immune subjects for SARS-CoV-2
Description
Prevalence of immune subjects for SARS-CoV-2 in a well-defined active healthy population, working at the hospital or not, leading to variable exposure levels
Time Frame
3 months
Title
Nature and quantity of anti-SARS-CoV-2 antibodies
Description
Nature and quantity of anti-SARS-CoV-2 antibodies: ImmunoglobulinM, ImmunoglobulinG and ImmunoglobulinA)
Time Frame
3 months
Title
Evolution of the different antibodies against the SARS-CoV-2 virus over time.
Description
The analysis of the evolution of serology results over time will be done by a mixed model taking into account the repeated framework of the data of a subject
Time Frame
6 months
Title
Prevalence of Anti-covid IgA response in the nasal mucosa
Description
Prevalence of Anti-covid IgA in volonteers RT/PCR+ and/or presence of antibodies at the 95 % threshold and/or COVID symptoms
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Person, adult volunteer outside of any acute infectious episode with SARS-CoV-2* (see paragraph indication), working at the Institute Curie and able to exercise their professional activity on one of the 3 sites of the Institute Curie: Paris, Orsay or Saint Cloud, or on the Campus of the Institute Pasteur. Person aged 18 or over. Information and consent of the person to the procedures related to the study (cf. information note / consent). From November 2020, person having presented at least one of the following criteria since January 2020: A positive diagnostic test for SARS-COV-2 by PCR on a nasopharyngeal sample or antigenic test, A positive SARS-CoV-2 serology, An anosmia or / and an ageusia, A respiratory infection ** associated with digestive signs ** whatever the working methods during confinement * Subjects who are not showing active SARS-CoV-2 infection are considered volunteers at the time of inclusion: people with no clinical signs ** suggestive of SARS-CoV-2 infection at the time of collection or having had an end of symptoms for more than 7 days [1]. ** fever, fatigue, cough, shortness of breath, difficulty to breath, loss of taste or smell, headache, body aches, conjunctivitis or cold, digestive problems (vomiting, diarrhea), whether or not the signs led to sick leave, treatment and / or hospitalization [2]. Exclusion Criteria: Declaration by the subject of signs suggestive of Coronavirus Infectious Disease 2019 (COVID-19) infection with SARS-CoV-2 in progress or for which the end of symptoms dates from less than 7 days Inability to submit to study monitoring for geographic, social or psychological reasons
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Fumoleau, PhD
Organizational Affiliation
Institut Curie
Official's Role
Study Director
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Institut Pasteur
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Learn more about this trial

COVID-19 Study of the Serological Response Against the Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV-2) Virus in 2 Types of Employees, Hospital and Non-hospital, at Institute Curie and Institute Pasteur

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