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

July 6, 2023 updated by: Institut Pasteur

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • CHU Amiens-Picardie
      • Asnieres sur seine, France
        • EHPAD Villa Concorde
      • Dijon, France
        • Chu Francois Mitterand
      • La Roche-sur-Yon, France
        • Centre Hospitalier Départemental de Vendée
      • Limoges, France
        • CHU Limoges
      • Lyon, France
        • Hôpital de la Croix Rousse
      • Mennecy, France
        • EHPAD Les Etangs
      • Nancy, France
        • CHRU de NANCY
      • Nancy, France
        • Hopitaux de Brabois
      • Orléans, France
        • CHR Orléans
      • Paris, France
        • Hôpital La Pitié Salpêtrière
      • Paris, France, 75015
        • Centre Médical de l'Institut Pasteur
      • Paris, France, 75015
        • Institut Pasteur
      • Paris, France, 75014
        • Institut Mutualiste
      • Paris, France
        • EHPAD Villa Lecourbe
      • Poitiers, France
        • CHU Poitiers
      • Rennes, France
        • Hopital Pontchaillou
      • Saint-Étienne, France
        • CHU Saint-Etienne
      • Strasbourg, France
        • CHRU de Strasbourg
      • Tourcoing, France
        • CH de Tourcoing
      • Tours, France
        • Hopital Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults (≥ 18 years old) at the time of collection (including minors for group 2c)

CORSER-1 : subjects who were in China between 08/2019 and 01/2020 and who have not been diagnosed with an SARS-CoV-2 infection;

CORSER-2 :

Sub-group 2a: suspected SARS-CoV-2 infection with a negative result of RT-PCR virus test on respiratory sample.

Sub-group 2b: contact or co-exposure with confirmed cases of SARS-CoV-2-infection.

Subgroup 2c: exposed to a risk of infection with SARS-CoV-2 in a geographic area of SARS-CoV-2 circulation.

Subgroup 2d : Staff of health care institutions

Subgroup 2e : hospitalized or residing in health care facilities

Subgroup 2f : Subjects with two symptomatic episodes of SARS-CoV-2- infection

CORSER 3 : returning from a humanitarian mission that started before the epidemic circulation of the virus in France

CORSER 4 : being vaccinated against COVID-19

CORSER 5 : with acute SARS-CoV-2 infection and controls

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CORSER-1a
Subjects who had been to China in the weeks before the outbreak began
Other: Human Biological samples
Blood samples for serological tests
Other: Human Biological samples
Blood samples, saliva, nasopharyngeal swab for serological tests
CORSER-1b
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
Blood samples for serological tests
Other: Human Biological samples
Blood samples, saliva, nasopharyngeal swab for serological tests
CORSER-2a
Subjects with suspected CoV-2-SARS infection with negative results from RT-PCR testing of respiratory specimens
Other: Human Biological samples
Blood samples for serological tests
Other: Human Biological samples
Blood samples, saliva, nasopharyngeal swab for serological tests
CORSER-2b
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
Blood samples for serological tests
Other: Human Biological samples
Blood samples, saliva, nasopharyngeal swab for serological tests
CORSER-2c

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
Blood samples for serological tests
Other: Human Biological samples
Blood samples, saliva, nasopharyngeal swab for serological tests
CORSER-2d
Staff of health care institutions
Other: Human Biological samples
Blood samples for serological tests
Other: Human Biological samples
Blood samples, saliva, nasopharyngeal swab for serological tests
CORSER-2e
Subjects in care, hospitalized or residing in health care facilities
Other: Human Biological samples
Blood samples for serological tests
Other: Human Biological samples
Blood samples, saliva, nasopharyngeal swab for serological tests
CORSER-3
Subjects returning from a humanitarian mission that started before 31/01/2020
Other: Human Biological samples
Blood samples for serological tests
Other: Human Biological samples
Blood samples, saliva, nasopharyngeal swab for serological tests
CORSER-2f
Subjects with two symptomatic episodes of SARS-CoV-2 infection
Other: Human Biological samples
Blood samples for serological tests
Other: Human Biological samples
Blood samples, saliva, nasopharyngeal swab for serological tests
CORSER-4
Subjects being vaccinated against COVID-19
Other: Human Biological samples
Blood samples for serological tests
Other: Human Biological samples
Blood samples, saliva, nasopharyngeal swab for serological tests
CORSER-5
Subjects with acute SARS-CoV-2 infection and uninfected controls
Other: Human Biological samples
Blood samples for serological tests
Other: Human Biological samples
Blood samples, saliva, nasopharyngeal swab for serological tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Investigators

  • Principal Investigator: Bruno HOEN, Pr, Institut Pasteur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2020

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 27, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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