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

Study Overview
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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.

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

Conditions
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SARS (Severe Acute Respiratory Syndrome), COVID-19

Intervention / Treatment
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* Other: Human Biological samples
* Other: Human Biological samples


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CORSER-1a<br>Subjects who had been to China in the weeks before the outbreak began | Other: Human Biological samples<br>* Blood samples for serological tests<br>|
| CORSER-1b<br>Subject who had a clinical profile compatible with an SARS-CoV-2 infection between August 1, 2019 and February 29, 2020 | Other: Human Biological samples<br>* Blood samples for serological tests<br>|
| CORSER-2a<br>Subjects with suspected CoV-2-SARS infection with negative results from RT-PCR testing of respiratory specimens | Other: Human Biological samples<br>* Blood samples for serological tests<br>|
| CORSER-2b<br>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 | Other: Human Biological samples<br>* Blood samples for serological tests<br>|
| CORSER-2c<br>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 | Other: Human Biological samples<br>* Blood samples for serological tests<br>|
| CORSER-2d<br>Staff of health care institutions | Other: Human Biological samples<br>* Blood samples for serological tests<br>|
| CORSER-2e<br>Subjects in care, hospitalized or residing in health care facilities | Other: Human Biological samples<br>* Blood samples for serological tests<br>|
| CORSER-3<br>Subjects returning from a humanitarian mission that started before 31/01/2020 | Other: Human Biological samples<br>* Blood samples for serological tests<br>|
| CORSER-2f<br>Subjects with two symptomatic episodes of SARS-CoV-2 infection | Other: Human Biological samples<br>* Blood samples, saliva, nasopharyngeal swab for serological tests<br>|
| CORSER-4<br>Subjects being vaccinated against COVID-19 | Other: Human Biological samples<br>* Blood samples, saliva, nasopharyngeal swab for serological tests<br>|
| CORSER-5<br>Subjects with acute SARS-CoV-2 infection and uninfected controls | Other: Human Biological samples<br>* Blood samples, saliva, nasopharyngeal swab for serological tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies | Proportion of asymptomatic subjects into seropositive population | One year |