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

Covid19 Clinical Trial

— COVID-OISE  

Official title:

Longitudinal Follow-up of a Population Cohort in a French City With High SARS-CoV-2 Circulation in Early 2020

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644159
• Other study ID #: 2020-060
• Status: Completed
• Start date: November 13, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2023
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: July 1, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS (Severe Acute Respiratory Syndrome)
• Severe Acute Respiratory Syndrome

Intervention

Other:
• Human biological samples
Blood , saliva, nasopharyngeal mucosa

Locations

Country	Name	City	State
France	Hôpital de Crépy en Valois	Crépy-en-Valois
France	Institut Pasteur	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of specific anti-SARS-CoV-2 antibodies in the different study groups.	Description of the serological status of individuals	2 years
Secondary	Presence of specific T cell response to the SARS-CoV-2	Detection over time the specific T cell response to the SARS-CoV-2 virus.	2 years