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

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

Sponsors

Lead sponsor: Institut Pasteur

Source Institut Pasteur
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.

Overall Status Recruiting
Start Date March 13, 2020
Completion Date February 28, 2023
Primary Completion Date February 28, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups. One year
Secondary Outcome
Measure Time Frame
Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies One year
Enrollment 1000
Condition
Intervention

Intervention type: Other

Intervention name: Human Biological samples

Description: Blood samples for serological tests

Eligibility

Sampling method: Non-Probability Sample

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)

Gender: All

Minimum age: 5 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Contact

Last name: Bruno HOEN, Pr

Phone: +33 1 40 61 37 60

Email: [email protected]

Location
facility status
CHU Amiens-Picardie | Amiens, France Completed
CHU François Mitterand | Dijon, France Completed
Centre Hospitalier Départemental de Vendée | La Roche-sur-Yon, France Recruiting Thomas Guimard, MD [email protected]
CHU Limoges | Limoges, France Recruiting Jean-François FAUCHER, Pr [email protected]
Hôpital de la Croix Rousse | Lyon, France Completed
CHRU de Nancy | Nancy, France Recruiting CHristine Perret-Guillaume, Pr
Hôpitaux de Brabois | Nancy, France Completed
CHR Orléans | Orléans, France Completed
Institut Pasteur | Paris, 75015, France Recruiting Marie-Noëlle UNGEHEUER, Dr +33 1 40 61 35 81 [email protected]
Hôpital la Pitié Salpetrière | Paris, France Recruiting Emmanuel Fournier, Pr [email protected]
CHU Poitiers | Poitiers, France Completed
Hôpital Pontchaillou | Rennes, France Completed
CHU Saint-Etienne | Saint-Étienne, France Completed
CHRU de Strasbourg | Strasbourg, France Completed
CH de Tourcoing | Tourcoing, France Completed
Hôpital Bretonneau | Tours, France Completed
Location Countries

France

Verification Date

April 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: CORSER-1

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

Arm group label: CORSER-2a

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

Arm group label: CORSER-2b

Description: 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

Arm group label: CORSER-2c

Description: Subjects who have been exposed to a risk of infection with CoV-2-CoV-RASS in a geographical area of 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

Arm group label: CORSER-2d

Description: Staff of health care institutions

Arm group label: CORSER-2e

Description: Subjects in care, hospitalized or residing in health care facilities

Acronym CORSER
Patient Data Undecided
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov