Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers
Use of Rapid Covid-19 Antibody Test Marketed by AAZ Laboratories in Healthcare Workers Presumably Being Infected by SARS-CoV-2
2 other identifiers
interventional
75
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2020
CompletedFirst Submitted
Initial submission to the registry
August 21, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2020
CompletedFebruary 3, 2021
August 1, 2020
5 months
August 21, 2020
February 2, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
To assess the predictive value of Covid-19 rapid test
Comparative study with Elisa Test
One week
Compare the results of rapid tests on serum and capillary samples
Performance evaluation of rapid tests according to the samples used
one week
Secondary Outcomes (2)
A posteriori diagnosis of a covid-19 recent infection with suggestive symptomatology
one week
Analysis of factors associated with negativity of PCR test on oropharyngeal swabs and positive serology
One week
Study Arms (2)
hospital healthcare workers
OTHERClinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test
private health professionals
OTHERClinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test
Interventions
To assess the immune status
Eligibility Criteria
You may qualify if:
- Healthcare professionals with symptoms suggestive of Covid-19 infection
You may not qualify if:
- any other subject
- pregnant women
- protected adult
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bichat University Hospital
Paris, F-75018, France
Study Officials
- PRINCIPAL INVESTIGATOR
Elisabeth Bouvet, MD
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2020
First Posted
August 25, 2020
Study Start
April 25, 2020
Primary Completion
September 25, 2020
Study Completion
October 25, 2020
Last Updated
February 3, 2021
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share