NCT04325646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2020

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

3.2 years

First QC Date

March 26, 2020

Last Update Submit

July 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.

    Description of the serological status of individuals by different detection tests

    One year

Secondary Outcomes (1)

  • Percentage of asymptomatic forms in individuals with anti-SARS-CoV-2 antibodies

    One year

Study Arms (11)

CORSER-1a

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

Other: Human Biological samples

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

CORSER-2a

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

Other: Human Biological samples

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

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

CORSER-2d

Staff of health care institutions

Other: Human Biological samples

CORSER-2e

Subjects in care, hospitalized or residing in health care facilities

Other: Human Biological samples

CORSER-3

Subjects returning from a humanitarian mission that started before 31/01/2020

Other: Human Biological samples

CORSER-2f

Subjects with two symptomatic episodes of SARS-CoV-2 infection

Other: Human Biological samples

CORSER-4

Subjects being vaccinated against COVID-19

Other: Human Biological samples

CORSER-5

Subjects with acute SARS-CoV-2 infection and uninfected controls

Other: Human Biological samples

Interventions

Blood samples for serological tests

CORSER-1aCORSER-1bCORSER-2aCORSER-2bCORSER-2cCORSER-2dCORSER-2eCORSER-3

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Affiliated with or benefiting from a Social Security system
  • State of health compatible with a blood sample as defined in the protocol

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

CHU Amiens-Picardie

Amiens, France

Location

EHPAD Villa Concorde

Asnières-sur-Seine, France

Location

CHU François Mitterand

Dijon, France

Location

Centre Hospitalier Départemental de Vendée

La Roche-sur-Yon, France

Location

CHU Limoges

Limoges, France

Location

Hôpital de la Croix Rousse

Lyon, France

Location

EHPAD Les Etangs

Mennecy, France

Location

CHRU de Nancy

Nancy, France

Location

Hôpitaux de Brabois

Nancy, France

Location

CHR Orléans

Orléans, France

Location

Institut Mutualiste

Paris, 75014, France

Location

Centre Médical de l'Institut Pasteur

Paris, 75015, France

Location

Institut Pasteur

Paris, 75015, France

Location

EHPAD Villa Lecourbe

Paris, France

Location

Hôpital la Pitié Salpetrière

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

Hôpital Pontchaillou

Rennes, France

Location

CHU Saint-Etienne

Saint-Etienne, France

Location

CHRU de Strasbourg

Strasbourg, France

Location

CH de Tourcoing

Tourcoing, France

Location

Hôpital Bretonneau

Tours, France

Location

Related Publications (2)

  • Garcia L, Woudenberg T, Rosado J, Dyer AH, Donnadieu F, Planas D, Bruel T, Schwartz O, Prazuck T, Velay A, Fafi-Kremer S, Batten I, Reddy C, Connolly E, McElheron M, Kennelly SP, Bourke NM, White MT, Pelleau S. Kinetics of the SARS-CoV-2 Antibody Avidity Response Following Infection and Vaccination. Viruses. 2022 Jul 8;14(7):1491. doi: 10.3390/v14071491.

  • Benetos A, Lai TP, Toupance S, Labat C, Verhulst S, Gautier S, Ungeheuer MN, Perret-Guillaume C, Levy D, Susser E, Aviv A. The Nexus Between Telomere Length and Lymphocyte Count in Seniors Hospitalized With COVID-19. J Gerontol A Biol Sci Med Sci. 2021 Jul 13;76(8):e97-e101. doi: 10.1093/gerona/glab026.

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, nasal swab, saliva

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Study Officials

  • Bruno HOEN, Pr

    Institut Pasteur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 27, 2020

Study Start

March 13, 2020

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Locations