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

COVID-19 Clinical Trial

— CORSER  

Official title:

Sero-epidemiological Study of the SARS-CoV-2 Virus in France: Constitution of a Collection of Human Biological Samples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325646
• Other study ID #: 2020-007
• Status: Completed
• Start date: March 13, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: July 2023
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• SARS (Severe Acute Respiratory Syndrome)
• Severe Acute Respiratory Syndrome

Intervention

Other:
• Human Biological samples
Blood samples for serological tests
• Human Biological samples
Blood samples, saliva, nasopharyngeal swab for serological tests

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens
France	EHPAD Villa Concorde	Asnieres sur seine
France	CHU François Mitterand	Dijon
France	Centre Hospitalier Départemental de Vendée	La Roche-sur-Yon
France	CHU Limoges	Limoges
France	Hôpital de la Croix Rousse	Lyon
France	EHPAD Les Etangs	Mennecy
France	CHRU de Nancy	Nancy
France	Hôpitaux de Brabois	Nancy
France	CHR Orléans	Orléans
France	Centre Médical de l'Institut Pasteur	Paris
France	EHPAD Villa Lecourbe	Paris
France	Hôpital la Pitié Salpetrière	Paris
France	Institut Mutualiste	Paris
France	Institut Pasteur	Paris
France	CHU Poitiers	Poitiers
France	Hôpital Pontchaillou	Rennes
France	CHU Saint-Etienne	Saint-Étienne
France	CHRU de Strasbourg	Strasbourg
France	CH de Tourcoing	Tourcoing
France	Hôpital Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.	Description of the serological status of individuals by different detection tests	One year
Secondary	Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies	Proportion of asymptomatic subjects into seropositive population	One year