Clinical trial NCT04325646: Sero-epidemiological Study of the SARS-CoV-2 Virus Responsible for COVID-19 in France
Official title: Sero-epidemiological Study of the SARS-CoV-2 Virus in France: Constitution of a Collection of Human Biological Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS (Severe Acute Respiratory Syndrome)
COVID-19
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
First posted: 2020-03-27
Enrollment: 5000
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.
timeFrame: One year
Secondary outcomes:
measure: Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies
timeFrame: One year
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Asnieres sur seine
country: France
facility: EHPAD Villa Concorde
city: Dijon
country: France
facility: CHU François Mitterand
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental de Vendée
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Mennecy
country: France
facility: EHPAD Les Etangs
city: Nancy
country: France
facility: CHRU de Nancy
city: Nancy
country: France
facility: Hôpitaux de Brabois
city: Orléans
country: France
facility: CHR Orléans
city: Paris
country: France
facility: Institut Mutualiste
city: Paris
country: France
facility: Centre Médical de l'Institut Pasteur
city: Paris
country: France
facility: Institut Pasteur
city: Paris
country: France
facility: EHPAD Villa Lecourbe
city: Paris
country: France
facility: Hôpital la Pitié Salpetrière
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Tourcoing
country: France
facility: CH de Tourcoing
city: Tours
country: France
facility: Hôpital Bretonneau
Study officials:
affiliation: Institut Pasteur
name: Bruno HOEN, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.