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Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers

Primary Purpose

Covid-19 Immune Status of Healthcare Workers

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
AAZ Covid-19 rapid test
Sponsored by
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Covid-19 Immune Status of Healthcare Workers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthcare professionals with symptoms suggestive of Covid-19 infection

Exclusion Criteria:

  • any other subject
  • pregnant women
  • protected adult

Sites / Locations

  • Bichat University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

hospital healthcare workers

private health professionals

Arm Description

Clinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test

Clinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test

Outcomes

Primary Outcome Measures

To assess the predictive value of Covid-19 rapid test
Comparative study with Elisa Test
Compare the results of rapid tests on serum and capillary samples
Performance evaluation of rapid tests according to the samples used

Secondary Outcome Measures

A posteriori diagnosis of a covid-19 recent infection with suggestive symptomatology
Use of rapid test
Analysis of factors associated with negativity of PCR test on oropharyngeal swabs and positive serology
Analysis of clinical data

Full Information

First Posted
August 21, 2020
Last Updated
February 2, 2021
Sponsor
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
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1. Study Identification

Unique Protocol Identification Number
NCT04525417
Brief Title
Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers
Official Title
Use of Rapid Covid-19 Antibody Test Marketed by AAZ Laboratories in Healthcare Workers Presumably Being Infected by SARS-CoV-2
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2020 (Actual)
Primary Completion Date
September 25, 2020 (Actual)
Study Completion Date
October 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

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 study objectives were to assess 1/the immune status of healthcare professionals with suggestive symptomatology of Covid-19 infection and 2/the sensitivity and specificity of AAZ rapid test by comparing it with a serological ELISA test. An open-label, monocentric, prospective, non-randomized study, is conducted, including 50 hospital healthcare professionals and 50 private health professionals. Knowledge of serostatus will achieve the implementation of a strategy of management of patients according to specific immunity of health professionals

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19 Immune Status of Healthcare Workers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Monocentric, open-label, prospective, non-randomized study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hospital healthcare workers
Arm Type
Other
Arm Description
Clinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test
Arm Title
private health professionals
Arm Type
Other
Arm Description
Clinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test
Intervention Type
Diagnostic Test
Intervention Name(s)
AAZ Covid-19 rapid test
Other Intervention Name(s)
ELISA test
Intervention Description
To assess the immune status
Primary Outcome Measure Information:
Title
To assess the predictive value of Covid-19 rapid test
Description
Comparative study with Elisa Test
Time Frame
One week
Title
Compare the results of rapid tests on serum and capillary samples
Description
Performance evaluation of rapid tests according to the samples used
Time Frame
one week
Secondary Outcome Measure Information:
Title
A posteriori diagnosis of a covid-19 recent infection with suggestive symptomatology
Description
Use of rapid test
Time Frame
one week
Title
Analysis of factors associated with negativity of PCR test on oropharyngeal swabs and positive serology
Description
Analysis of clinical data
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthcare professionals with symptoms suggestive of Covid-19 infection Exclusion Criteria: any other subject pregnant women protected adult
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Bouvet, MD
Organizational Affiliation
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bichat University Hospital
City
Paris
ZIP/Postal Code
F-75018
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers

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