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Study of the Incidence of SARS-CoV-2 Infection (COVID-19) (CovImmune 2)

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ClinicalTrials.gov Identifier: NCT04429594
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:

This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study.

The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality.

The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.


Condition or disease Intervention/treatment Phase
Coronavirus Infections Other: blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of the Incidence of SARS-CoV-2 Infection in the Alpes-Maritimes Department by Analysis of the Specific Humoral and Cellular Response During Deconfinement
Actual Study Start Date : July 28, 2020
Estimated Primary Completion Date : July 15, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
volonteers Other: blood sampling
blood sampling at J0, M6, M12, M24, M36, M48, M60




Primary Outcome Measures :
  1. positive serologies [ Time Frame: 12 months ]
    number of positive serologies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any major subject, voluntary, exposed to the public from 11 May 2020 informed of the study by partner institutions (Departmental Council 06), affiliated to a social security scheme,

Exclusion Criteria:

  • Subject protected by law under tutorship or guardianship, or who cannot participate in a clinical study under the terms of Article L. 1121-16 of the French Public Health Code

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): NCT04429594


Contacts
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Contact: Barbara SEITZ, MCUPH 334 92 03 55 02 seitz-polski.b@chu-nice.fr

Locations
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France
University Nice Hospital Recruiting
Nice, France, 06000
Contact: Barbara SEITZ- POLSKI    334.92.03.55.02    seitz-polski.b@chu-nice.fr   
Principal Investigator: barbara SEITZ POLSKI         
Sub-Investigator: sonia BOYER SUAVET         
Sub-Investigator: Christian PRADIER         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT04429594    
Other Study ID Numbers: 20-PP-14
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases