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Health Professional Exposure Assessment to Covid-19 (SERODRON)

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diagnostic test Covid-19
Sponsored by
Tourcoing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CH Roubaix
  • CH Tourcoing
  • CH Wasquehal
  • CH Wattrelos

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

health workers at hospital

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of contaminated personnel
Number of contaminated personnel by occupational category and department on day 1.

Secondary Outcome Measures

Number of contaminated personnel
Number of contaminated personnel by professional category and by service at month 3 a by serological test
Number of contaminated personnel
Number of contaminated personnel by professional category and by service at month 6 a by serological test
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
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
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
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.

Full Information

First Posted
June 10, 2020
Last Updated
May 9, 2022
Sponsor
Tourcoing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04429724
Brief Title
Health Professional Exposure Assessment to Covid-19
Acronym
SERODRON
Official Title
Health Professional Exposure Assessment to Covid-19
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
March 16, 2021 (Actual)
Study Completion Date
March 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tourcoing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
health workers at hospital
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic test Covid-19
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of contaminated personnel
Description
Number of contaminated personnel by occupational category and department on day 1.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Number of contaminated personnel
Description
Number of contaminated personnel by professional category and by service at month 3 a by serological test
Time Frame
month 3
Title
Number of contaminated personnel
Description
Number of contaminated personnel by professional category and by service at month 6 a by serological test
Time Frame
month 6
Title
Number of symptomatic staff by occupational category and service
Description
Number of symptomatic staff by occupational category and service at Month 3 with positive RT-PCR Cov2 SARS
Time Frame
month 3
Title
Number of symptomatic staff by occupational category and service
Description
Number of symptomatic staff by occupational category and service at Month 6 with positive RT-PCR Cov2 SARS
Time Frame
month 6
Title
Number of contaminated personnel with effective protection
Description
Number of contaminated personnel with effective protection: evolution of the antibody index at day 1, month 3 and month 6
Time Frame
evolution at day 1, month 3 and month 6
Title
comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies
Description
comparison of socio-demographic characteristics and co-morbidities between patients losing their antibodies and those maintaining their antibodies between two stitch dates.
Time Frame
month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PATOZ Pierre, PharmD
Organizational Affiliation
CH Tourcoing
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Roubaix
City
Roubaix
Country
France
Facility Name
CH Tourcoing
City
Tourcoing
Country
France
Facility Name
CH Wasquehal
City
Wasquehal
Country
France
Facility Name
CH Wattrelos
City
Wattrelos
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Health Professional Exposure Assessment to Covid-19

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