Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers

NCT ID: NCT04525417

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-25

Study Completion Date

2020-10-25

Brief Summary

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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

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Conditions

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Covid-19 Immune Status of Healthcare Workers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Monocentric, open-label, prospective, non-randomized study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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hospital healthcare workers

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

Group Type OTHER

AAZ Covid-19 rapid test

Intervention Type DIAGNOSTIC_TEST

To assess the immune status

private health professionals

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

Group Type OTHER

AAZ Covid-19 rapid test

Intervention Type DIAGNOSTIC_TEST

To assess the immune status

Interventions

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AAZ Covid-19 rapid test

To assess the immune status

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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ELISA test

Eligibility Criteria

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Inclusion Criteria

* Healthcare professionals with symptoms suggestive of Covid-19 infection

Exclusion Criteria

* any other subject
* pregnant women
* protected adult
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Bouvet, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Bichat University Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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ID RCB 2020-A01031-38

Identifier Type: OTHER

Identifier Source: secondary_id

GERES20200409

Identifier Type: -

Identifier Source: org_study_id

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