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

NCT ID: NCT04369066

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1971 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-28
• Study Completion Date: 2022-05-13

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Subjects who are not showing active SARS-Cov2 infection

Group Type: OTHER

Blood samples (collection of 5 mL of blood in a dry tube)

Intervention Type: DIAGNOSTIC_TEST

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.

Nasopharyngeal swabs

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Curie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Fumoleau, PhD

Role: STUDY_DIRECTOR

Institut Curie

Locations

Institut Curie

Paris, , France

Institut Pasteur

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 33259646 (View on PubMed)

Other Identifiers

IC 2020-07

Identifier Type: -

Identifier Source: org_study_id