Health Professional Exposure Assessment to Covid-19 (SERODRON)

Understanding the SARS-Cov2 epidemic is a major public health issue, both in the community and in the hospital sector. Because of their central position in the management of patients infected with COVID-19, hospital staff may be considered at high risk of infection. The development of serological tests makes it possible to reliably document a contamination, symptomatic or not, that is more than 3 weeks old. These tests, combined with clinical questioning of the symptoms, make it possible to determine the proportion of asymptomatic infections whose impact in the transmission of this disease appears to be major. The duration of the presence of the antibodies that are hoped to neutralize after infection with CoV2-SARS remains uncertain. Documenting the evolution of antibody levels and their monitoring in a population at high risk of re-exposure to CoV2-SARS is a major issue in understanding this disease and in assessing the risk of infection among healthcare workers.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: Diagnostic test Covid-19

Detailed Description

This is a multi-center, prospective, interventional, low-risk, low-constraint, biological collection study to assess the exposure of health care workers to COVID-19.

Three blood samples will be taken at day 1, month 3 and month 6. The blood samples will be stored in a serum biological collection. A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.

In the event of the appearance of symptoms between samples, a self-questionnaire will be completed by the participating personnel as well as an invitation to screening by RT-PCR SARS Cov2 according to standard practices in force at the national level as well as an additional serological test.

• Study Type: Interventional
• Enrollment (Actual): 2129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Roubaix, France
    • CH Roubaix
  • Tourcoing, France
    • Ch Tourcoing
  • Wasquehal, France
    • CH Wasquehal
  • Wattrelos, France
    • CH Wattrelos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Staff on duty in the health facility
• Eligible to be drawn
• Beneficiary subject affiliated or entitled to a social security scheme

Exclusion Criteria:

• Minor patient
• Refusal to participate
• Patient under guardianship
• Patient under guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: health workers at hospital; Three blood samples will be taken at day 1, month 3 and month 6. A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.	Diagnostic test: Diagnostic test Covid-19; Three blood samples will be taken at day 1, month 3 and month 6 A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of contaminated personnel	Number of contaminated personnel by occupational category and department on day 1.	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of contaminated personnel	Number of contaminated personnel by professional category and by service at month 3 a by serological test	month 3
Number of contaminated personnel	Number of contaminated personnel by professional category and by service at month 6 a by serological test	month 6
Number of symptomatic staff by occupational category and service	Number of symptomatic staff by occupational category and service at Month 3 with positive RT-PCR Cov2 SARS	month 3
Number of symptomatic staff by occupational category and service	Number of symptomatic staff by occupational category and service at Month 6 with positive RT-PCR Cov2 SARS	month 6
Number of contaminated personnel with effective protection	Number of contaminated personnel with effective protection: evolution of the antibody index at day 1, month 3 and month 6	evolution at day 1, month 3 and month 6
comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies	comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies between two stitch dates.	month 6

Collaborators and Investigators

• Sponsor: Tourcoing Hospital
• Investigators: Principal Investigator: PATOZ Pierre, PharmD, Ch Tourcoing

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 6, 2020
• Primary Completion (ACTUAL): March 16, 2021
• Study Completion (ACTUAL): March 16, 2021

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (ACTUAL): June 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RIPH_2020_8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No