Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers

Covid-19 Immune Status of Healthcare Workers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04525417
• Other study ID #: GERES20200409
• Secondary ID: ID RCB 2020-A010
• Status: Completed
• Phase: N/A
• Start date: April 25, 2020
• Est. completion date: October 25, 2020

Study information

• Verified date: August 2020
• Source: Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 25, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthcare professionals with symptoms suggestive of Covid-19 infection

Exclusion Criteria:

• any other subject

• pregnant women

• protected adult

Related Conditions & MeSH terms

• Covid-19 Immune Status of Healthcare Workers

Intervention

Diagnostic Test:
• AAZ Covid-19 rapid test
To assess the immune status

Locations

Country	Name	City	State
France	Bichat University Hospital	Paris

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the predictive value of Covid-19 rapid test	Comparative study with Elisa Test	One week
Primary	Compare the results of rapid tests on serum and capillary samples	Performance evaluation of rapid tests according to the samples used	one week
Secondary	A posteriori diagnosis of a covid-19 recent infection with suggestive symptomatology	Use of rapid test	one week
Secondary	Analysis of factors associated with negativity of PCR test on oropharyngeal swabs and positive serology	Analysis of clinical data	One week