Sero-epidemiological Study of the SARS-CoV-2 Virus Responsible for COVID-19 in France

NCT ID: NCT04325646

Last Updated: 2023-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-13

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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SARS (Severe Acute Respiratory Syndrome) COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CORSER-1a

Subjects who had been to China in the weeks before the outbreak began

Human Biological samples

Intervention Type OTHER

Blood samples 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

Human Biological samples

Intervention Type OTHER

Blood samples for serological tests

CORSER-2a

Subjects with suspected CoV-2-SARS infection with negative results from RT-PCR testing of respiratory specimens

Human Biological samples

Intervention Type OTHER

Blood samples 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

Human Biological samples

Intervention Type OTHER

Blood samples 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.

* study among pupils, their parents and siblings, as well as teachers and non-teaching staff of a high-school located in Oise
* study among pupils from 5 to 12 and their parents in elementary schools located in Oise
* study among choir members

Human Biological samples

Intervention Type OTHER

Blood samples for serological tests

CORSER-2d

Staff of health care institutions

Human Biological samples

Intervention Type OTHER

Blood samples for serological tests

CORSER-2e

Subjects in care, hospitalized or residing in health care facilities

Human Biological samples

Intervention Type OTHER

Blood samples for serological tests

CORSER-3

Subjects returning from a humanitarian mission that started before 31/01/2020

Human Biological samples

Intervention Type OTHER

Blood samples for serological tests

CORSER-2f

Subjects with two symptomatic episodes of SARS-CoV-2 infection

Human Biological samples

Intervention Type OTHER

Blood samples, saliva, nasopharyngeal swab for serological tests

CORSER-4

Subjects being vaccinated against COVID-19

Human Biological samples

Intervention Type OTHER

Blood samples, saliva, nasopharyngeal swab for serological tests

CORSER-5

Subjects with acute SARS-CoV-2 infection and uninfected controls

Human Biological samples

Intervention Type OTHER

Blood samples, saliva, nasopharyngeal swab for serological tests

Interventions

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Human Biological samples

Blood samples for serological tests

Intervention Type OTHER

Human Biological samples

Blood samples, saliva, nasopharyngeal swab for serological tests

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruno HOEN, Pr

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur

Locations

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CHU Amiens-Picardie

Amiens, , France

Site Status

EHPAD Villa Concorde

Asnières-sur-Seine, , France

Site Status

CHU François Mitterand

Dijon, , France

Site Status

Centre Hospitalier Départemental de Vendée

La Roche-sur-Yon, , France

Site Status

CHU Limoges

Limoges, , France

Site Status

Hôpital de la Croix Rousse

Lyon, , France

Site Status

EHPAD Les Etangs

Mennecy, , France

Site Status

CHRU de Nancy

Nancy, , France

Site Status

Hôpitaux de Brabois

Nancy, , France

Site Status

CHR Orléans

Orléans, , France

Site Status

Institut Mutualiste

Paris, , France

Site Status

Centre Médical de l'Institut Pasteur

Paris, , France

Site Status

Institut Pasteur

Paris, , France

Site Status

EHPAD Villa Lecourbe

Paris, , France

Site Status

Hôpital la Pitié Salpetrière

Paris, , France

Site Status

CHU Poitiers

Poitiers, , France

Site Status

Hôpital Pontchaillou

Rennes, , France

Site Status

CHU Saint-Etienne

Saint-Etienne, , France

Site Status

CHRU de Strasbourg

Strasbourg, , France

Site Status

CH de Tourcoing

Tourcoing, , France

Site Status

Hôpital Bretonneau

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 35891471 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33528568 (View on PubMed)

Other Identifiers

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2020-007

Identifier Type: -

Identifier Source: org_study_id

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