An interventional study of Blood samples (collection of 5 mL of blood in a dry tube) and Nasopharyngeal swabs in Volunteers From the Institute Curie and Institute Pasteur Staff Who Are Not Showing Active SARS-CoV-2 Infection, sponsored by Institut Curie. Completed at 2 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Institut Curie · Not applicable, Interventional, and Health services research
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:
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
Institut Curie is the lead sponsor of 134 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
From November 2020, person having presented at least one of the following criteria since January 2020:
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:
Diagnostic Test: Blood samples (collection of 5 mL of blood in a dry tube) · Diagnostic Test: Nasopharyngeal swabs
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.
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.
Antibodies against the SARS-CoV-2 virus in serum at inclusion
Detection of antibodies against the SARS-CoV-2 virus with serological tests
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
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)
Time frame: 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
Time frame: 3 months
Nature and quantity of anti-SARS-CoV-2 antibodies
Nature and quantity of anti-SARS-CoV-2 antibodies: ImmunoglobulinM, ImmunoglobulinG and ImmunoglobulinA)
Time frame: 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
Time frame: 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
Time frame: 6 months
Plan to share: 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.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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