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

NCT04429594 | Recruiting

• 1 other identifier: 20-PP-14
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infections

Outcome Measures

Primary Outcomes (1)

• positive serologies

  number of positive serologies

  12 months

Study Arms (1)

volonteers

OTHER

Other: blood sampling

Interventions

blood sampling OTHER

blood sampling at J0, M6, M12, M24, M36, M48, M60

volonteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

University Nice Hospital

Nice, 06000, France

RECRUITING

Related Publications (2)

• Graca D, Brglez V, Allouche J, Zorzi K, Fernandez C, Teisseyre M, Cremoni M, Benzaken S, Pradier C, Seitz-Polski B. Both Humoral and Cellular Immune Responses to SARS-CoV-2 Are Essential to Prevent Infection: a Prospective Study in a Working Vaccinated Population from Southern France. J Clin Immunol. 2023 Nov;43(8):1724-1739. doi: 10.1007/s10875-023-01558-9. Epub 2023 Aug 22.

  PMID: 37606852 DERIVED

• Buscot M, Cremoni M, Graca D, Brglez V, Courjon J, Allouche J, Teisseyre M, Boyer L, Barriere J, Chamorey E, Carles M, Seitz-Polski B. Breakthrough infections due to SARS-CoV-2 Delta variant: relation to humoral and cellular vaccine responses. Front Immunol. 2023 Mar 30;14:1145652. doi: 10.3389/fimmu.2023.1145652. eCollection 2023.

  PMID: 37063916 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Barbara SEITZ, MCUPH

CONTACT

334 92 03 55 02; seitz-polski.b@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: July 28, 2020
• Primary Completion: July 15, 2025
• Study Completion: December 31, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)