Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers

Not Applicable

Completed

• Conditions: Covid-19 Immune Status of Healthcare Workers
• Interventions: Diagnostic Test: AAZ Covid-19 rapid test

• Registration Number: NCT04525417
• Lead Sponsor: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-25
• Status Verified: 2020-08
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-22
• Study First Posted: 2020-08-25
• Primary Completion: 2020-09-25
• Study Completion: 2020-10-25
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Healthcare professionals with symptoms suggestive of Covid-19 infection

Exclusion Criteria

• any other subject
• pregnant women
• protected adult

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hospital healthcare workers	AAZ Covid-19 rapid test	Clinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test
private health professionals	AAZ Covid-19 rapid test	Clinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bichat University Hospital; 🇫🇷 Paris, France