Sero-epidemiological Study of the SARS-CoV-2 Virus in France: Constitution of a Collection of Human Biological Samples
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institut Pasteur
- Enrollment
- 5,000
- Locations
- 21
- Primary Endpoint
- Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 5 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.
Time Frame: One year
Description of the serological status of individuals by different detection tests
Secondary Outcomes
- Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies(One year)