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

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ClinicalTrials.gov Identifier: NCT04644159
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur

Study Description
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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
SARS (Severe Acute Respiratory Syndrome) Covid19 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
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Study Type : Observational
Estimated 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 : November 13, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. Presence of specific anti-SARS-CoV-2 antibodies in the different study groups. [ Time Frame: 2 years ]
    Description of the serological status of individuals


Secondary Outcome Measures :
  1. Presence of specific T cell response to the SARS-CoV-2 [ Time Frame: 2 years ]
    Detection over time the specific T cell response to the SARS-CoV-2 virus.


Biospecimen Retention:   Samples With DNA
blood, saliva, nasopharyngeal mucosa

Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04644159


Contacts
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Contact: Sandrine Fernandes Pellerin +33145688179 sandrine.fernandes-pellerin@pasteur.fr
Contact: Laurie Pinaud laurie.pinaud@pasteur.fr

Locations
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France
Hôpital de Crépy en Valois Recruiting
Crépy-en-Valois, France, 60800
Contact: Cécile DURU, Dr         
Contact: Aymar KOFFI, Dr         
Institut Pasteur Recruiting
Paris, France, 75724
Contact: Marie-Noëlle UNGEHEUER,       marie-noelle.ungeheuer@pasteur.fr   
Sponsors and Collaborators
Institut Pasteur
Investigators
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Principal Investigator: Bruno HOEN, Pr Institut Pasteur
More Information
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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT04644159    
Other Study ID Numbers: 2020-060
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases