Coronavirus InfectionCOVIDORNCT04387968
Epidemiological Study of the Covid-19 Presto Test - The "COVIDOR" Study
An observational study of Coronavirus Infection, run by Raphael Serreau at 2 sites in France.
Trial summary
The "COVIDOR" epidemiological study. Our study would be the first at the community level in Orleans Métropole, aiming to determine the link between a positive IgM level on the serological test and a healthy carrier of covid-19 in agents in contact with the public. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- Covid-19 presto test
- How many people
- 3,228 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Aug 2020to 4 Oct 2021
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Blood sample to be taken after self-bite. A consent form is given to the officer. A drop of blood is deposited on a coverslip, 2 drops of reagents allow migration to the gel. Reading in 15 minutes 1. strip: negative result 2. bands: positive result An authorized person, subject to medical confidentiality, reports the result in the medical file and informs the agent of the result. He is given a paper document signed by the SMP with the procedure to follow.
Who may be able to join
- All the agents of the 3 local authorities (Loire Valley Region, CCTVL and Orléans Métropole) being voluntary to be tested for the COVID-PRESTO® test COVID-19 IgG / IgM rapid test (whole blood / serum / plasma) - Cassette
- Volunteer to get tested
Who cannot join
- Opposition to the participation of the study
- Covid-19 disease
Trial locations and contacts
2 sites in 1 country.
France2 sites
Unité de Recherche PARADICT-O - Orléans
Orléans, 45000
Unité de Recherche PARADICT-O - Service de Médecine - Orléans Métropole
Orléans, 45000
About this study
Official title: Epidemiological Study of the Covid-19 Presto Test Among Agents of the Local Authorities of CCTVL, Region Centre Val de Loire and Orleans Métropole. Correlation of IgM Level According to Contact With the Public
The "COVIDOR" epidemiological study. Our study would be the first at the community level in Orleans Métropole, aiming to determine the link between a positive IgM level on the serological test and a healthy carrier of covid-19 in agents in contact with the public. It would provide epidemiological surveillance of anti-covid-19 immunity in the community
Read the detailed description
The metropolitan area of Orléans Métropole has 6,700 agents divided into 250 different trades and consequently multiple exposures and risks.
The global covid-19 pandemic has affected France and the Loiret, the sarscov-2 coronavirus, has infected several thousand people. On May 7, 2020, there were 75 deaths at the CHRO hospital in Orleans, excluding EHPAD. The contamination rate of the population of the Loiret department has been estimated at 5.6% of the population by Public Health France. This rate is very low and does not allow the use of serological screening tests because of too many false positives or false negatives, there should be a prevalence of the disease greater than 60%. The French health authorities do not recommend the use of a screening test at the present time in view of the uncertainties of the results of this test. The Loiret Management Center, the Department and Orléans Métropole have decided to offer a covid-19 serological screening test, the covid-19 presto test, to voluntary territorial agents regardless of their return to work following the national "deconfinement "on May 11, 2020 This can only be done through an epidemiological surveillance study validated as part of a research protocol.
- Conditions
- Coronavirus Infection
- Being tested
- Covid-19 presto test
- Keywords
- covid-19, serology, depistage, public health, voluntary agents
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19 presto testDiagnostic test
Also called Covid-19 viro
Use an auto-test in 15 minutes get the results about covid-19 anticorps
| Study group | Role | What they receive |
|---|---|---|
| agents in contact with the public | patients working with children, policemen, desk office Receives: Diagnostic Test: Covid-19 presto test | |
| agents with no contact with the public | administrative workers Receives: Diagnostic Test: Covid-19 presto test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the prevalence of Covid-19 infection, coronavirus (SARS coronavirus-2) in territorial agents in the 3 structures : CCTVL, Loire Valley Region Centre, Orleans Metropolitan city
Covid-19 attack rate by measuring the frequency of anti-covid-19 IgM in each of the territorial structures
Measured: 15 minutes
Secondary outcomes (1)
Determine if there is a relationship between the profession carried out by the agents of the territorial community of Orleans metropolitan city, the Loire Valley Region, the CCTVL and contamination by covid-19
Search for a correlation of covid-19 immunity based on the officer's position, if he is in contact with the public.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start24 Aug 2020
- Primary completion13 Jul 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus InfectionStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 3,228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raphael Serreau
- Sponsor type
- University, hospital or other
- Collaborators
- François Rabelais University, Assistance Publique - Hôpitaux de Paris, University Hospital, Paris
- Responsible party
- Sponsor-investigator, Raphael Serreau, Orléans Métropole Service de Médecine Préventive
- Investigators
- Dr Raphael SERREAU, MD, PhD, Principal investigator, Orleans Metropole
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387968
- Sponsor's protocol ID
- 2020-A01414-35
- Acronym
- COVIDOR
- Status last verified
- Oct 2021
- First submitted
- 12 May 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Blood sample to be taken after self-bite. A consent form is given to the officer. A drop of blood is deposited on a coverslip, 2 drops of reagents allow migration to the gel. Reading in 15 minutes 1. strip: negative result 2. bands: positive result An authorized person, subject to medical confidentiality, reports the result in the medical file and informs the agent of the result. He is given a paper document signed by the SMP with the procedure to follow.
Publications
Hanane G, Amine Z, Roomila N, Prazuck T, Amirouche A, Olivier V, Benyamina A, Serreau R. COVID-19 seroprevalence among local authority workers from Orleans Metropole, the Community of Communes of the Terres du Val de Loire, the local public service management centre of the Loiret department and the Region Centre Val de Loire: a prospective epidemiological study. BMJ Open. 2023 May 22;13(5):e066504. doi: 10.1136/bmjopen-2022-066504.
PubMed 37217267
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of the Covid-19 Presto Test Among Agents of the Local Authorities of CCTVL, Region Centre Val de Loire and Orleans Métropole. Correlation of IgM Level According to Contact With the Public
- ClinicalTrials.gov ID
- NCT04387968
- Acronym / sponsor ID
- COVIDOR / 2020-A01414-35
- Conditions
- Coronavirus Infection
- Keywords
- covid-19, serology, depistage, public health, voluntary agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,228 participants (actual)
- Lead sponsor
- Raphael SerreauUniversity, hospital or other
- Collaborators
- François Rabelais University, Assistance Publique - Hôpitaux de Paris, University Hospital, Paris
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 14 May 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 "COVIDOR" epidemiological study. Our study would be the first at the community level in Orleans Métropole, aiming to determine the link between a positive IgM level on the serological test and a healthy carrier of covid-19 in agents in contact with the public. It would provide epidemiological surveillance of anti-covid-19 immunity in the community
Detailed description
The metropolitan area of Orléans Métropole has 6,700 agents divided into 250 different trades and consequently multiple exposures and risks.
The global covid-19 pandemic has affected France and the Loiret, the sarscov-2 coronavirus, has infected several thousand people. On May 7, 2020, there were 75 deaths at the CHRO hospital in Orleans, excluding EHPAD. The contamination rate of the population of the Loiret department has been estimated at 5.6% of the population by Public Health France. This rate is very low and does not allow the use of serological screening tests because of too many false positives or false negatives, there should be a prevalence of the disease greater than 60%. The French health authorities do not recommend the use of a screening test at the present time in view of the uncertainties of the results of this test. The Loiret Management Center, the Department and Orléans Métropole have decided to offer a covid-19 serological screening test, the covid-19 presto test, to voluntary territorial agents regardless of their return to work following the national "deconfinement "on May 11, 2020 This can only be done through an epidemiological surveillance study validated as part of a research protocol.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| agents in contact with the public | – | Diagnostic Test: Covid-19 presto testpatients working with children, policemen, desk office |
| agents with no contact with the public | – | Diagnostic Test: Covid-19 presto testadministrative workers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Blood sample to be taken after self-bite. A consent form is given to the officer. A drop of blood is deposited on a coverslip, 2 drops of reagents allow migration to the gel. Reading in 15 minutes 1. strip: negative result 2. bands: positive result An authorized person, subject to medical confidentiality, reports the result in the medical file and informs the agent of the result. He is given a paper document signed by the SMP with the procedure to follow.
Key inclusion criteria (2 listed)
- All the agents of the 3 local authorities (Loire Valley Region, CCTVL and Orléans Métropole) being voluntary to be tested for the COVID-PRESTO® test COVID-19 IgG / IgM rapid test (whole blood / serum / plasma) - Cassette
- Volunteer to get tested
Key exclusion criteria (2 listed)
- Opposition to the participation of the study
- Covid-19 disease
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 |
|---|---|---|
| Covid-19 presto testAlso: Covid-19 viroUse an auto-test in 15 minutes get the results about covid-19 anticorps | Diagnostic test | agents in contact with the public, agents with no contact with the public |
Primary outcome
Study the prevalence of Covid-19 infection, coronavirus (SARS coronavirus-2) in territorial agents in the 3 structures : CCTVL, Loire Valley Region Centre, Orleans Metropolitan city
Time frame: 15 minutes
Covid-19 attack rate by measuring the frequency of anti-covid-19 IgM in each of the territorial structures
1 secondary outcome
Determine if there is a relationship between the profession carried out by the agents of the territorial community of Orleans metropolitan city, the Loire Valley Region, the CCTVL and contamination by covid-19
Time frame: 6 months
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 5 Oct 2021.
- Derived from this study: PubMed 37217267Hanane G, Amine Z, Roomila N, Prazuck T, Amirouche A, Olivier V, Benyamina A, Serreau R. COVID-19 seroprevalence among local authority workers from Orleans Metropole, the Community of Communes of the Terres du Val de Loire, the local public service management centre of the Loiret department and the Region Centre Val de Loire: a prospective epidemiological study. BMJ Open. 2023 May 22;13(5):e066504. doi: 10.1136/bmjopen-2022-066504.
- Individual participant dataSharing planned: Undecided. Blood sample to be taken after self-bite. A consent form is given to the officer. A drop of blood is deposited on a coverslip, 2 drops of reagents allow migration to the gel. Reading in 15 minutes 1. strip: negative result 2. bands: positive result An authorized person, subject to medical confidentiality, reports the result in the medical file and informs the agent of the result. He is given a paper document signed by the SMP with the procedure to follow.
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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.
Dr Raphael SERREAU, MD, PhD principal investigator
Orleans Metropole
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus Infection, run by Raphael Serreau at 2 sites 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 2 inclusion and 2 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Study the prevalence of Covid-19 infection, coronavirus (SARS coronavirus-2) in territorial agents in the 3 structures : CCTVL, Loire Valley Region Centre, Orleans Metropolitan city (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04387968, which also lists 1 linked publication.
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 5 Oct 2021.