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

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ClinicalTrials.gov Identifier: NCT04325646
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur

Study Description
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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.


Condition or disease Intervention/treatment
SARS (Severe Acute Respiratory Syndrome) COVID-19 Other: Human Biological 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
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sero-epidemiological Study of the SARS-CoV-2 Virus in France: Constitution of a Collection of Human Biological Samples
Actual Study Start Date : March 13, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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
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
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
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
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
CORSER-2d
Staff of health care institutions
 Other: Human Biological samples
Blood samples for serological tests
CORSER-2e
Subjects in care, hospitalized or residing in health care facilities
 Other: Human Biological samples
Blood samples 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
CORSER-2f
Subjects with two symptomatic episodes of SARS-CoV-2 infection
 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, saliva, nasopharyngeal swab for serological tests


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies [ Time Frame: One year ]
    Proportion of asymptomatic subjects into seropositive population


Biospecimen Retention:   Samples With DNA
serum, plasma

Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

CORSER-1 :

  • Adults (≥ 18 years old) at the time of collection;
  • Subjects who were in China between 01/08/2019 and 31/01/2020 and who have not been diagnosed with an SARS-CoV-2 infection;

CORSER-2 :

- Adults or minors (group 2c) at the time of sampling;

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

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

Subgroup 2c: a person who has been 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 : Subjects in care, hospitalized or residing in health care facilities

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

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

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04325646


Contacts
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Contact: Sandrine Fernandes Pellerin +33145688179 sandrine.fernandes-pellerin@pasteur.fr
Contact: Nathalie Jolly nathalie.jollly@pasteur.fr

Locations
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Sponsors and Collaborators
Institut Pasteur
Investigators
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Principal Investigator: Bruno HOEN, Pr Institut Pasteur
More Information
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT04325646    
Other Study ID Numbers: 2020-007
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases