COVID-OISE: Longitudinal Follow-up of a Population Cohort in a French City With High SARS-CoV-2 Circulation, in Early 2020 [COVID-19]

Sponsor
Institut Pasteur (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04644159
Collaborator
(none)
2,000
2
35.6
1000
28.1

Study Details

Study Description

Brief Summary

An initial retrospective epidemiological investigation was conducted in a city north of France after the diagnosis of the first case of COVID-19 on February 2020. Sero-epidemiological studies were conducted in this town by the Institut Pasteur in early 2020 among families, teachers and non-teaching staff of the high and elementary schools.

The goal of this new project is to better characterize the specific immunity generated by the infection within this community. The specific immune response to the SARS-CoV-2 virus will be followed for a period of 2 years from the initial circulation of the virus, within a large cohort of participants covering all age groups from 5 years-old onwards. The study will focus on systemic humoral and cell responses, immunity of the nasopharyngeal mucosa and the humoral response present in saliva. Follow-up of participants in this cohort and monitoring of the virus circulation within this community would help to determine the protective character against re-infection of the natural immunity generated by SARS-CoV-2.

Condition or Disease Intervention/Treatment Phase
  • Other: Human biological samples

Detailed Description

An initial retrospective epidemiological investigation was conducted in a city north of France after the diagnosis of the first case of COVID-19 on February 2020. Sero-epidemiological studies were conducted in this town by the Institut Pasteur in early 2020 among families, teachers and non-teaching staff of the high and elementary schools.

These surveys have documented the circulation of SARS-CoV-2 in one of the first French COVID-19 outbreaks and this study proposes to better characterize the specific immunity generated by the infection among this community. Indeed, the nature of this immunity and its persistence over time are crucial information. The goal of this new project is to explore the specific immune response to the SARS CoV 2 virus for a period of 2 years from the initial circulation of the virus in this north of France city, within a large cohort of participants in the general population covering all age groups from 5 years of age but also in patients and residents of retirement homes in this city. It is expected that the immune response conferred by natural infection or vaccination will differ according to age.

This study will focus on systemic humoral and cell responses, immunity of the nasopharyngeal mucosa and the humoral response present in saliva. The genetic basis of the diversity of humoral responses induced by SARS-CoV-2 and those related to the multiplicity of clinical manifestations of COVID-19 will also be investigated. This would provide initial evidence to determine the protective character against re-infection of the natural immunity generated by CoV-2-SARS. Finally, these data will be used to model the intra-family transmission of the virus.

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Longitudinal Follow-up of a Population Cohort in a French City With High SARS-CoV-2 Circulation in Early 2020
Actual Study Start Date :
Nov 13, 2020
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Housolds

Pupils, teachers and non-teaching staff who attended schools of the city during the 2019-2020 school year and members of their households

Other: Human biological samples
Blood , saliva, nasopharyngeal mucosa

Subjects hospitalized or residing in health care facilities

Residents and patients from retirement homes and long-term care units

Other: Human biological samples
Blood , saliva, nasopharyngeal mucosa

Staff of health care institutions

Staff of health care institutions

Other: Human biological samples
Blood , saliva, nasopharyngeal mucosa

Outcome Measures

Primary Outcome Measures

  1. Presence of specific anti-SARS-CoV-2 antibodies in the different study groups. [2 years]

    Description of the serological status of individuals

Secondary Outcome Measures

  1. Presence of specific T cell response to the SARS-CoV-2 [2 years]

    Detection over time the specific T cell response to the SARS-CoV-2 virus.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adultes and minors from 5 years old

  • 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 and for which the legal representative or tutor person could not be contacted.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital de Crépy en Valois Crépy-en-Valois France 60800
2 Institut Pasteur Paris France 75724

Sponsors and Collaborators

  • Institut Pasteur

Investigators

  • Principal Investigator: Bruno HOEN, Pr, Institut Pasteur

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Pasteur
ClinicalTrials.gov Identifier:
NCT04644159
Other Study ID Numbers:
  • 2020-060
First Posted:
Nov 25, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022