COVID-19 Seroconversion Study Among GHdC Staff Members - Summer 2020
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Serological tests for SARS Cov-2
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Be a member of the staff of the Grand Hôpital de Charleroi who wishes to participate in order to know their immunity related to SARS CoV-2 after the first wave of pandemic.
Exclusion Criteria:
- Not be part of the staff of the Grand Hôpital de Charleroi.
Sites / Locations
- Grand Hôpital de Charleroi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Serological tests
Arm Description
All staff at GHdC who want to know their level of antibodies against SARS CoV-2
Outcomes
Primary Outcome Measures
Serological tests to know the level of antibodies against SARS CoV-2
The hospital has organized several schedules and appointments for each staff member depending on the ability to analyze laboratory samples and blood draws.
Secondary Outcome Measures
Full Information
NCT ID
NCT04723290
First Posted
January 21, 2021
Last Updated
March 24, 2021
Sponsor
Grand Hôpital de Charleroi
1. Study Identification
Unique Protocol Identification Number
NCT04723290
Brief Title
COVID-19 Seroconversion Study Among GHdC Staff Members - Summer 2020
Official Title
SARS-CoV-2 Seroconversion Study Among GHdC Staff Members
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 20, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grand Hôpital de Charleroi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The management of the Grand Hôpital de Charleroi hospital authorized the performance of a serology for each member of the establishment's staff in order to better characterize the proportion of its employees who have already been in contact with the SARS CoV-2 virus for organizational and evaluation purposes symptoms.
Detailed Description
At the start of the SARS-CoV-2 pandemic, several workers had symptoms compatible with COVID-19 at a time when PCR (smear) testing was only allowed for hospitalized people. In addition, the PCR test has a fairly low sensitivity. In this context, serology can make it possible to determine whether the symptoms are indeed linked to exposure to SARS-CoV-2.
As a hospital, and in order to prepare for a possible second epidemic wave, it is also useful to know the proportion of staff members who have already been in contact with the virus for organizational purposes and symptom assessment.
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2817 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Serological tests
Arm Type
Experimental
Arm Description
All staff at GHdC who want to know their level of antibodies against SARS CoV-2
Intervention Type
Diagnostic Test
Intervention Name(s)
Serological tests for SARS Cov-2
Intervention Description
Each participant will have a blood test on a dry tube of maximum 8 ml of whole blood
Primary Outcome Measure Information:
Title
Serological tests to know the level of antibodies against SARS CoV-2
Description
The hospital has organized several schedules and appointments for each staff member depending on the ability to analyze laboratory samples and blood draws.
Time Frame
up to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be a member of the staff of the Grand Hôpital de Charleroi who wishes to participate in order to know their immunity related to SARS CoV-2 after the first wave of pandemic.
Exclusion Criteria:
Not be part of the staff of the Grand Hôpital de Charleroi.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie de Visscher, MD
Organizational Affiliation
Grand Hôpital de Charleroi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grand Hôpital de Charleroi
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6060
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
At this moment, there is no plan to share the results
Citations:
PubMed Identifier
35891515
Citation
de Visscher N, Holemans X, Gillain A, Kornreich A, Lagasse R, Piette P, Ventura M, Thys F. SARS-CoV-2 Seroprevalence among Healthcare Workers after the First and Second Pandemic Waves. Viruses. 2022 Jul 14;14(7):1535. doi: 10.3390/v14071535.
Results Reference
derived
Learn more about this trial
COVID-19 Seroconversion Study Among GHdC Staff Members - Summer 2020
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