NCT04429724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,129

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

July 6, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2021

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

June 10, 2020

Last Update Submit

May 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of contaminated personnel

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

    day 1

Secondary Outcomes (6)

  • Number of contaminated personnel

    month 3

  • Number of contaminated personnel

    month 6

  • Number of symptomatic staff by occupational category and service

    month 3

  • Number of symptomatic staff by occupational category and service

    month 6

  • Number of contaminated personnel with effective protection

    evolution at day 1, month 3 and month 6

  • +1 more secondary outcomes

Study Arms (1)

health workers at hospital

EXPERIMENTAL

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

Interventions

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.

health workers at hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CH Roubaix

Roubaix, France

Location

CH Tourcoing

Tourcoing, France

Location

CH Wasquehal

Wasquehal, France

Location

CH Wattrelos

Wattrelos, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • PATOZ Pierre, PharmD

    CH TOURCOING

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
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 6, 2020

Primary Completion

March 16, 2021

Study Completion

March 16, 2021

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations