- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04325646
Sero-epidemiological Study of the SARS-CoV-2 Virus Responsible for COVID-19 in France (CORSER)
Sero-epidemiological Study of the SARS-CoV-2 Virus in France: Constitution of a Collection of Human Biological Samples
On January 2020, the discovery of a new coronavirus (SARS-CoV-2) was officially announced by the Chinese health authorities and the World Health Organization (WHO). Its complete genome was sequenced by the laboratory of respiratory infection viruses at the Institut Pasteur on 29 January 2020 in France. This will allow the identification of antigenic structures involved in the immune response and the development of serological diagnostic tests.
Many questions are being asked about this new virus and the infection it causes, including questions about the percentage of asymptomatic and pauci-symptomatic forms. Serological studies can provide answers to these questions. There is no serological test for SARS-COV-2 yet, but the laboratory of respiratory infection viruses at the Institut Pasteur is working on its development.
This study proposes to carry out a collection of samples taken from subjects who travelled to China before the epidemic outbreak or suspected of being infected with SARS-CoV-2.
As soon as it is available, serology will be performed on the collected samples.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
On January 2020, the discovery of a new coronavirus (SARS-CoV-2) was officially announced by the Chinese health authorities and the World Health Organization (WHO). This new virus is presented as the causative agent of pneumonias. Its complete genome was sequenced by the laboratory of respiratory infection viruses at the Institut Pasteur on 29 January 2020 in France. This will allow the identification of antigenic structures involved in the immune response and the development of serological diagnostic tests.
Many questions are being asked about this new virus and the infection it causes, including questions about the transition from animal to human occur, the beginning of viral circulation in humans, the period of contagiousness, the percentage of asymptomatic and pauci-symptomatic forms. Serological studies can provide answers to these questions. There is no serological test for SARS-COV-2 yet, but the laboratory of respiratory infection viruses at the Institut Pasteur is working on its development.
This study proposes to carry out a collection of samples taken from subjects who travelled to China before the epidemic outbreak or suspected of being infected with SARS-CoV-2.
As soon as it is available, serology will be performed on the collected samples.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Sandrine Fernandes Pellerin
- Phone Number: +33145688179
- Email: sandrine.fernandes-pellerin@pasteur.fr
Study Contact Backup
- Name: Nathalie Jolly
- Email: nathalie.jollly@pasteur.fr
Study Locations
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-
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Amiens, France
- CHU Amiens-Picardie
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Asnieres sur seine, France
- EHPAD Villa Concorde
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Dijon, France
- CHU François Mitterand
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La Roche-sur-Yon, France
- Centre Hospitalier Departemental de Vendee
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Limoges, France
- CHU Limoges
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Lyon, France
- Hôpital de La Croix Rousse
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Mennecy, France
- EHPAD Les Etangs
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Nancy, France
- CHRU de Nancy
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Nancy, France
- Hôpitaux de Brabois
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Orléans, France
- CHR Orleans
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Paris, France
- Hôpital La Pitié Salpêtrière
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Paris, France, 75015
- Centre Médical de l'Institut Pasteur
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Paris, France, 75015
- Institut Pasteur
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Paris, France, 75014
- Institut Mutualiste
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Paris, France
- EHPAD Villa Lecourbe
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Poitiers, France
- CHU Poitiers
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Rennes, France
- Hôpital Pontchaillou
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Saint-Étienne, France
- CHU Saint-Etienne
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Strasbourg, France
- CHRU de Strasbourg
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Tourcoing, France
- CH de Tourcoing
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Tours, France
- Hôpital Bretonneau
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Adults (≥ 18 years old) at the time of collection (including minors for group 2c)
CORSER-1 : subjects who were in China between 08/2019 and 01/2020 and who have not been diagnosed with an SARS-CoV-2 infection;
CORSER-2 :
Sub-group 2a: suspected SARS-CoV-2 infection with a negative result of RT-PCR virus test on respiratory sample.
Sub-group 2b: contact or co-exposure with confirmed cases of SARS-CoV-2-infection.
Subgroup 2c: exposed to a risk of infection with SARS-CoV-2 in a geographic area of SARS-CoV-2 circulation.
Subgroup 2d : Staff of health care institutions
Subgroup 2e : hospitalized or residing in health care facilities
Subgroup 2f : Subjects with two symptomatic episodes of SARS-CoV-2- infection
CORSER 3 : returning from a humanitarian mission that started before the epidemic circulation of the virus in France
CORSER 4 : being vaccinated against COVID-19
CORSER 5 : with acute SARS-CoV-2 infection and controls
Description
Inclusion Criteria:
- Affiliated with or benefiting from a Social Security system
- State of health compatible with a blood sample as defined in the protocol
Exclusion Criteria:
- Person benefiting from a legal protection measure or unable to express informed consent to participation
- Have had an infectious episode and/or respiratory signs in the 14 days prior to the scheduled visit (CORSER 1 and 2a, 2b)
- Have been in contact with a confirmed case of SARS-CoV-2 infection within 14 days prior to the date of the visit.(CORSER 1 and 2a, 2b)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CORSER-1a
Subjects who had been to China in the weeks before the outbreak began
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Blood samples for serological tests
Blood samples, saliva, nasopharyngeal swab for serological tests
|
CORSER-1b
Subject who had a clinical profile compatible with an SARS-CoV-2 infection between August 1, 2019 and February 29, 2020
|
Blood samples for serological tests
Blood samples, saliva, nasopharyngeal swab for serological tests
|
CORSER-2a
Subjects with suspected CoV-2-SARS infection with negative results from RT-PCR testing of respiratory specimens
|
Blood samples for serological tests
Blood samples, saliva, nasopharyngeal swab for serological tests
|
CORSER-2b
Contacts or co-exposures of confirmed CoV-2-SARS infection cases, or who have worked or stayed in a hospital where confirmed CoV-2-SARS infection has been managed
|
Blood samples for serological tests
Blood samples, saliva, nasopharyngeal swab for serological tests
|
CORSER-2c
Subjects who have been exposed to a risk of infection with SARS-CoV-2 in a geographical area of SARS-CoV-2 circulation.
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Blood samples for serological tests
Blood samples, saliva, nasopharyngeal swab for serological tests
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CORSER-2d
Staff of health care institutions
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Blood samples for serological tests
Blood samples, saliva, nasopharyngeal swab for serological tests
|
CORSER-2e
Subjects in care, hospitalized or residing in health care facilities
|
Blood samples for serological tests
Blood samples, saliva, nasopharyngeal swab for serological tests
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CORSER-3
Subjects returning from a humanitarian mission that started before 31/01/2020
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Blood samples for serological tests
Blood samples, saliva, nasopharyngeal swab for serological tests
|
CORSER-2f
Subjects with two symptomatic episodes of SARS-CoV-2 infection
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Blood samples for serological tests
Blood samples, saliva, nasopharyngeal swab for serological tests
|
CORSER-4
Subjects being vaccinated against COVID-19
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Blood samples for serological tests
Blood samples, saliva, nasopharyngeal swab for serological tests
|
CORSER-5
Subjects with acute SARS-CoV-2 infection and uninfected controls
|
Blood samples for serological tests
Blood samples, saliva, nasopharyngeal swab for serological tests
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.
Time Frame: One year
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Description of the serological status of individuals by different detection tests
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies
Time Frame: One year
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Proportion of asymptomatic subjects into seropositive population
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One year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bruno HOEN, Pr, Institut Pasteur
Publications and helpful links
General Publications
- Garcia L, Woudenberg T, Rosado J, Dyer AH, Donnadieu F, Planas D, Bruel T, Schwartz O, Prazuck T, Velay A, Fafi-Kremer S, Batten I, Reddy C, Connolly E, McElheron M, Kennelly SP, Bourke NM, White MT, Pelleau S. Kinetics of the SARS-CoV-2 Antibody Avidity Response Following Infection and Vaccination. Viruses. 2022 Jul 8;14(7):1491. doi: 10.3390/v14071491.
- Benetos A, Lai TP, Toupance S, Labat C, Verhulst S, Gautier S, Ungeheuer MN, Perret-Guillaume C, Levy D, Susser E, Aviv A. The Nexus Between Telomere Length and Lymphocyte Count in Seniors Hospitalized With COVID-19. J Gerontol A Biol Sci Med Sci. 2021 Jul 13;76(8):e97-e101. doi: 10.1093/gerona/glab026.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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