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

NCT04644159 | Completed

• 1 other identifier: 2020-060
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

SARS (Severe Acute Respiratory Syndrome); Covid19

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

  2 years

Secondary Outcomes (1)

• Presence of specific T cell response to the SARS-CoV-2

  2 years

Study Arms (3)

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

Subjects hospitalized or residing in health care facilities

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

Other: Human biological samples

Staff of health care institutions

Staff of health care institutions

Other: Human biological samples

Interventions

Human biological samples OTHER

Blood , saliva, nasopharyngeal mucosa

Housolds; Staff of health care institutions; Subjects hospitalized or residing in health care facilities

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pupils, their parents and siblings, as well as teachers and non-teaching staff of a high and elementary schools located in a city north of France.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (2)

Hôpital de Crépy en Valois

Crépy-en-Valois, 60800, France

Location

Institut Pasteur

Paris, 75724, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva, nasopharyngeal mucosa

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases

Study Officials

• Marie-Noëlle Ungeheuer, Dr

  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: November 18, 2020
• First Posted: November 25, 2020
• Study Start: November 13, 2020
• Primary Completion: June 30, 2022
• Study Completion: July 1, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

FR (2)