COVID-19 Seroconversion Study Among GHdC Staff Members - Summer 2020

Sponsor

Grand Hôpital de Charleroi (Other)

Overall Status

Completed

CT.gov ID

NCT04723290

Collaborator

(none)

2,817

Enrollment

Location

Arm

6.4

Actual Duration (Months)

442

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Diagnostic Test: Serological tests for SARS Cov-2	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2817 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

SARS-CoV-2 Seroconversion Study Among GHdC Staff Members

Actual Study Start Date :

Jun 20, 2020

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Serological tests All staff at GHdC who want to know their level of antibodies against SARS CoV-2	Diagnostic Test: Serological tests for SARS Cov-2 Each participant will have a blood test on a dry tube of maximum 8 ml of whole blood

Arm

Intervention/Treatment

Experimental: Serological tests

All staff at GHdC who want to know their level of antibodies against SARS CoV-2

Diagnostic Test: Serological tests for SARS Cov-2

Each participant will have a blood test on a dry tube of maximum 8 ml of whole blood

Outcome Measures

Primary Outcome Measures

Serological tests to know the level of antibodies against SARS CoV-2 [up to 6 weeks]
The hospital has organized several schedules and appointments for each staff member depending on the ability to analyze laboratory samples and blood draws.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grand Hôpital de Charleroi	Charleroi	Hainaut	Belgium	6060

Sponsors and Collaborators

Grand Hôpital de Charleroi

Investigators

Principal Investigator: Nathalie de Visscher, MD, Grand Hôpital de Charleroi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Grand Hôpital de Charleroi

ClinicalTrials.gov Identifier:

NCT04723290

Other Study ID Numbers:

SERO-SARS-CoV-2 GHdC

First Posted:

Jan 25, 2021

Last Update Posted:

Mar 25, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Mar 25, 2021