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

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Pasteur Institute

Status

Completed

Conditions

COVID-19
SARS (Severe Acute Respiratory Syndrome)

Treatments

Other: Human Biological samples

Study type

Observational

Funder types

Industry

Identifiers

NCT04325646
2020-007

Details and patient eligibility

About

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.

Full 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.

Enrollment

5,000 patients

Sex

All

Ages

5+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

5,000 participants in 11 patient groups

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

Trial contacts and locations

21

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Central trial contact

Nathalie Jolly; Sandrine Fernandes Pellerin

Data sourced from clinicaltrials.gov

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