Covid-19 Immune Status of Healthcare WorkersNCT04525417
Rapid Screening Test for Covid-19 Antibodies in Healthcare Workers
A study testing AAZ Covid-19 rapid test in people with Covid-19 Immune Status of Healthcare Workers, run by Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19 Immune Status of Healthcare Workers
- What is being tested?
- AAZ Covid-19 rapid test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2020to 25 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthcare professionals with symptoms suggestive of Covid-19 infection
Who cannot join
- any other subject
- pregnant women
- protected adult
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Rapid Covid-19 Antibody Test Marketed by AAZ Laboratories in Healthcare Workers Presumably Being Infected by SARS-CoV-2
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
- Being tested
- AAZ Covid-19 rapid test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAZ Covid-19 rapid testDiagnostic test
Also called ELISA test
To assess the immune status
| Study group | Role | What they receive |
|---|---|---|
| hospital healthcare workers | Other | Clinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test Receives: Diagnostic Test: AAZ Covid-19 rapid test |
| private health professionals | Other | Clinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test Receives: Diagnostic Test: AAZ Covid-19 rapid test |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the predictive value of Covid-19 rapid test
Comparative study with Elisa Test
Measured: One week
Compare the results of rapid tests on serum and capillary samples
Performance evaluation of rapid tests according to the samples used
Measured: one week
Secondary outcomes (2)
A posteriori diagnosis of a covid-19 recent infection with suggestive symptomatology
Use of rapid test
Measured: one week
Analysis of factors associated with negativity of PCR test on oropharyngeal swabs and positive serology
Analysis of clinical data
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start25 Apr 2020
- Primary completion25 Sep 2020
- Study completion25 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19 Immune Status of Healthcare WorkersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, open-label, prospective, non-randomized study
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Elisabeth Bouvet, MD, Principal investigator, Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525417
- Sponsor's protocol ID
- GERES20200409
- Other IDs
- ID RCB 2020-A01031-38
- Status last verified
- Aug 2020
- First submitted
- 21 Aug 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Rapid Covid-19 Antibody Test Marketed by AAZ Laboratories in Healthcare Workers Presumably Being Infected by SARS-CoV-2
- ClinicalTrials.gov ID
- NCT04525417
- Acronym / sponsor ID
- GERES20200409
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents InfectieuxResearch network
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric, open-label, prospective, non-randomized study
| Arm | Type | Receives |
|---|---|---|
| hospital healthcare workers | Other | Diagnostic Test: AAZ Covid-19 rapid testClinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test |
| private health professionals | Other | Diagnostic Test: AAZ Covid-19 rapid testClinical examination; Veinous blood sampling for serological testing; capillary drawing to perform a rapid Covid-19 test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare professionals with symptoms suggestive of Covid-19 infection
Key exclusion criteria (3 listed)
- any other subject
- pregnant women
- protected adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAZ Covid-19 rapid testAlso: ELISA testTo assess the immune status | Diagnostic test | hospital healthcare workers, private health professionals |
Primary outcome
To assess the predictive value of Covid-19 rapid test
Time frame: One week
Comparative study with Elisa Test
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
2 secondary outcomes
A posteriori diagnosis of a covid-19 recent infection with suggestive symptomatology
Time frame: one week
Analysis of factors associated with negativity of PCR test on oropharyngeal swabs and positive serology
Time frame: One week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Bouvet, MD principal investigator
Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAZ Covid-19 rapid test in people with Covid-19 Immune Status of Healthcare Workers, run by Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the predictive value of Covid-19 rapid test (time frame: One week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.