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

Completed
Conditions
COVID-19
SARS (Severe Acute Respiratory Syndrome)
Interventions
Other: Human Biological samples
Registration Number
NCT04325646
Lead Sponsor
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
5000
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
CORSER-2dHuman Biological samplesStaff of health care institutions
CORSER-4Human Biological samplesSubjects being vaccinated against COVID-19
CORSER-2aHuman Biological samplesSubjects with suspected CoV-2-SARS infection with negative results from RT-PCR testing of respiratory specimens
CORSER-1bHuman Biological samplesSubject who had a clinical profile compatible with an SARS-CoV-2 infection between August 1, 2019 and February 29, 2020
CORSER-2bHuman Biological samplesContacts 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
CORSER-3Human Biological samplesSubjects returning from a humanitarian mission that started before 31/01/2020
CORSER-1aHuman Biological samplesSubjects who had been to China in the weeks before the outbreak began
CORSER-2cHuman Biological samplesSubjects 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
CORSER-2eHuman Biological samplesSubjects in care, hospitalized or residing in health care facilities
CORSER-2fHuman Biological samplesSubjects with two symptomatic episodes of SARS-CoV-2 infection
CORSER-5Human Biological samplesSubjects with acute SARS-CoV-2 infection and uninfected controls
Primary Outcome Measures
NameTimeMethod
Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.One year

Description of the serological status of individuals by different detection tests

Secondary Outcome Measures
NameTimeMethod
Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodiesOne year

Proportion of asymptomatic subjects into seropositive population

Trial Locations

Locations (21)

Hôpitaux de Brabois

🇫🇷

Nancy, France

CHRU de Nancy

🇫🇷

Nancy, France

CHU Saint-Etienne

🇫🇷

Saint-Étienne, France

Hôpital de la Croix Rousse

🇫🇷

Lyon, France

EHPAD Villa Concorde

🇫🇷

Asnieres sur seine, France

EHPAD Les Etangs

🇫🇷

Mennecy, France

Hôpital Pontchaillou

🇫🇷

Rennes, France

Institut Mutualiste

🇫🇷

Paris, France

Institut Pasteur

🇫🇷

Paris, France

CHU Limoges

🇫🇷

Limoges, France

CHR Orléans

🇫🇷

Orléans, France

CHRU de Strasbourg

🇫🇷

Strasbourg, France

Centre Médical de l'Institut Pasteur

🇫🇷

Paris, France

Hôpital la Pitié Salpetrière

🇫🇷

Paris, France

Centre Hospitalier Départemental de Vendée

🇫🇷

La Roche-sur-Yon, France

Hôpital Bretonneau

🇫🇷

Tours, France

CHU Amiens-Picardie

🇫🇷

Amiens, France

CHU François Mitterand

🇫🇷

Dijon, France

CHU Poitiers

🇫🇷

Poitiers, France

EHPAD Villa Lecourbe

🇫🇷

Paris, France

CH de Tourcoing

🇫🇷

Tourcoing, France

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