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Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers

Sponsor
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux (Other)
Overall Status
Completed
CT.gov ID
NCT04525417
Collaborator
(none)
75
Enrollment
1
Location
2
Arms
6
Actual Duration (Months)
12.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: AAZ Covid-19 rapid test
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Monocentric, open-label, prospective, non-randomized studyMonocentric, open-label, prospective, non-randomized study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Use of Rapid Covid-19 Antibody Test Marketed by AAZ Laboratories in Healthcare Workers Presumably Being Infected by SARS-CoV-2
Actual Study Start Date :
Apr 25, 2020
Actual Primary Completion Date :
Sep 25, 2020
Actual Study Completion Date :
Oct 25, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To assess the predictive value of Covid-19 rapid test [One week]

      Comparative study with Elisa Test

    2. 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

    1. A posteriori diagnosis of a covid-19 recent infection with suggestive symptomatology [one week]

      Use of rapid test

    2. Analysis of factors associated with negativity of PCR test on oropharyngeal swabs and positive serology [One week]

      Analysis of clinical data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Healthcare professionals with symptoms suggestive of Covid-19 infection
    Exclusion Criteria:

    • any other subject

    • pregnant women

    • protected adult

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bichat University Hospital Paris France F-75018

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
    ClinicalTrials.gov Identifier:
    NCT04525417
    Other Study ID Numbers:
    • GERES20200409
    • ID RCB 2020-A01031-38
    First Posted:
    Aug 25, 2020
    Last Update Posted:
    Feb 3, 2021
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Feb 3, 2021