Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers

February 2, 2021 updated by: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

Use of Rapid Covid-19 Antibody Test Marketed by AAZ Laboratories in Healthcare Workers Presumably Being Infected by SARS-CoV-2

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, F-75018
        • Bichat University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthcare professionals with symptoms suggestive of Covid-19 infection

Exclusion Criteria:

  • any other subject
  • pregnant women
  • protected adult

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: hospital healthcare workers
Clinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test
Diagnostic test: AAZ Covid-19 rapid test
To assess the immune status
Other Names:
  • ELISA test
Other: private health professionals
Clinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test
Diagnostic test: AAZ Covid-19 rapid test
To assess the immune status
Other Names:
  • ELISA test

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

Investigators

  • Principal Investigator: Elisabeth Bouvet, MD, Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2020

Primary Completion (Actual)

September 25, 2020

Study Completion (Actual)

October 25, 2020

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

August 22, 2020

First Posted (Actual)

August 25, 2020

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GERES20200409
  • ID RCB 2020-A01031-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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