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)

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

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

Study Overview

• Status: Completed
• Conditions: Volunteers From the Institute Curie and Institute Pasteur Staff Who Are Not Showing Active SARS-CoV-2 Infection
• Intervention / Treatment: Diagnostic test: Blood samples (collection of 5 mL of blood in a dry tube); Diagnostic test: Nasopharyngeal swabs

• Study Type: Interventional
• Enrollment (Actual): 1971
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75015
    • Institut Pasteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Subjects who are not showing active SARS-Cov2 infection

Diagnostic test: Blood samples (collection of 5 mL of blood in a dry tube); 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.; Diagnostic test: Nasopharyngeal swabs; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	9 months
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	3 months
Nature and quantity of anti-SARS-CoV-2 antibodies	Nature and quantity of anti-SARS-CoV-2 antibodies: ImmunoglobulinM, ImmunoglobulinG and ImmunoglobulinA)	3 months
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	6 months
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	6 months

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Study Director: Pierre Fumoleau, PhD, Institut Curie

Publications and helpful links

General Publications

• Anna F, Goyard S, Lalanne AI, Nevo F, Gransagne M, Souque P, Louis D, Gillon V, Turbiez I, Bidard FC, Gobillion A, Savignoni A, Guillot-Delost M, Dejardin F, Dufour E, Petres S, Richard-Le Goff O, Choucha Z, Helynck O, Janin YL, Escriou N, Charneau P, Perez F, Rose T, Lantz O. High seroprevalence but short-lived immune response to SARS-CoV-2 infection in Paris. Eur J Immunol. 2021 Jan;51(1):180-190. doi: 10.1002/eji.202049058. Epub 2020 Dec 23.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Actual): January 6, 2022
• Study Completion (Actual): May 13, 2022

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Adults; Volunteers
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: IC 2020-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No