Volunteers From the Institute Curie and Institute Pasteur Staff Who Are Not Showing Active SARS-CoV-2 InfectionCurie-O-SANCT04369066
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
A study testing Blood samples (collection of 5 mL of blood in a dry tube) and Nasopharyngeal swabs in people with Volunteers From the Institute Curie and Institute Pasteur Staff Who Are Not Showing Active SARS-CoV-2 Infection, run by Institut Curie at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volunteers From the Institute Curie and Institute Pasteur Staff Who Are Not Showing Active SARS-CoV-2 Infection
- What is being tested?
- Blood samples (collection of 5 mL of blood in a dry tube) and Nasopharyngeal swabs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,971 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Apr 2020to 13 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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].
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read more
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
- Being tested
- Blood samples (collection of 5 mL of blood in a dry tube), Nasopharyngeal swabs
- Keywords
- Adults, Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples (collection of 5 mL of blood in a dry tube)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 swabsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects who are not showing active SARS-Cov2 infection | Other | Not described Receives: Diagnostic Test: Blood samples (collection of 5 mL of blood in a dry tube); Diagnostic Test: Nasopharyngeal swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibodies against the SARS-CoV-2 virus in serum at inclusion
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Secondary outcomes (5)
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)
Measured: 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
Measured: 3 months
Nature and quantity of anti-SARS-CoV-2 antibodies
Nature and quantity of anti-SARS-CoV-2 antibodies: ImmunoglobulinM, ImmunoglobulinG and ImmunoglobulinA)
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start28 Apr 2020
- Primary completion6 Jan 2022
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Volunteers From the Institute Curie and Institute Pasteur Staff Who Are Not Showing Active SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,971 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Fumoleau, PhD, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369066
- Sponsor's protocol ID
- IC 2020-07
- Acronym
- Curie-O-SA
- Status last verified
- Nov 2023
- First submitted
- 27 Apr 2020
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 33259646
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04369066
- Acronym / sponsor ID
- Curie-O-SA / IC 2020-07
- Keywords
- Adults, Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,971 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who are not showing active SARS-Cov2 infection | Other | Diagnostic Test: Blood samples (collection of 5 mL of blood in a dry tube), Diagnostic Test: Nasopharyngeal swabs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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,
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Subjects who are not showing active SARS-Cov2 infection |
| Nasopharyngeal swabsThe 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. | Diagnostic test | Subjects who are not showing active SARS-Cov2 infection |
Primary outcome
Antibodies against the SARS-CoV-2 virus in serum at inclusion
Time frame: 1 day
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Antibodies against the SARS-CoV-2 virus in serum at 1 month
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
Detection of antibodies against the SARS-CoV-2 virus with serological tests
5 secondary outcomes
Comparative performance of anti-SARS-CoV-2 antibody detection techniques
Time frame: 9 months
Prevalence of immune subjects for SARS-CoV-2
Time frame: 3 months
Nature and quantity of anti-SARS-CoV-2 antibodies
Time frame: 3 months
Evolution of the different antibodies against the SARS-CoV-2 virus over time.
Time frame: 6 months
Prevalence of Anti-covid IgA response in the nasal mucosa
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Background: PubMed 33259646Anna 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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Fumoleau, PhD study director
Institut Curie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples (collection of 5 mL of blood in a dry tube) and Nasopharyngeal swabs in people with Volunteers From the Institute Curie and Institute Pasteur Staff Who Are Not Showing Active SARS-CoV-2 Infection, run by Institut Curie at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibodies against the SARS-CoV-2 virus in serum at inclusion (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04369066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.