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OpenTrials
Completed

NCT Number: NCT04525417

Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers

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

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Key information

Conditions

Covid-19 Immune Status of Healthcare Workers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bichat University Hospital

Paris, F-75018, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthcare professionals with symptoms suggestive of Covid-19 infection

Exclusion criteria

  • any other subject
  • pregnant women
  • protected adult

Treatment and study plan

AAZ Covid-19 rapid test

Diagnostic Test

To assess the immune status

Other names: ELISA test

Primary outcomes

  1. To assess the predictive value of Covid-19 rapid test

    Time frame: One week

    Comparative study with Elisa Test

  2. 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

Secondary outcomes

  1. A posteriori diagnosis of a covid-19 recent infection with suggestive symptomatology

    Time frame: one week

    Use of rapid test

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

    Time frame: One week

    Analysis of clinical data

Sponsors and collaborators

Lead sponsor

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

Network

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 25, 2020
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.