Covid19FLUCOVIDNCT04991246
Project FLUx COntact-CoVID-19 Faculty of Medicine Paris-Saclay
A study testing Antigenic tests (on saliva samples), Individual electronic sensor port and Atmospheric measurements of CO2 in people with Covid19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The worldwide health system has been marked by the SARS-CoV-2 pandemic. French educational system has been upset, especially medical schools, which, because of their hospital location, are particularly exposed to the spread of the virus. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Antigenic tests (on saliva samples), Individual electronic sensor port and Atmospheric measurements of CO2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2021to 14 Jan 2022
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers of adult men and women over 18 from the Paris-Saclay Medicine UFR
- Belonging to the teaching staff
- Belonging to the promotions of DFGSM 2 and 3, and DFASM 1 and 2 (2nd to 5th year of medical study)
- administrative staff
- Affiliated to a social security scheme or beneficiary (excluding AME)
- Informed and written consent
Who cannot join
- Absence of intercurrent disease before inclusion
- Positive antigenic or PCR test at the time of inclusion
Trial locations and contacts
1 site in 1 country.
About this study
The worldwide health system has been marked by the SARS-CoV-2 pandemic. French educational system has been upset, especially medical schools, which, because of their hospital location, are particularly exposed to the spread of the virus. The medical school of Paris-Saclay University, located within bicetre University Hospital, AP-HP, must therefore adapt on a daily basis to ensure educational continuity. Taking advantage of an exceptional scientific ecosystem, innovative viral epidemic propagation modeling approaches based on both simulation and contact tracing data will be tested in real-life conditions. These propagation models will serve to scientifically optimize future educational organization procedures in this medical school.
Read the detailed description
All the participants will be equipped with individual wireless contact tracing technology. Anonymised contact events will be automatically monitored for a period of two months to measure the daily contact flow density between the students at medical school. Epidemic simulation models will be enriched with these real contact tracing data to generate optimized viral propagation probability networks. During the same period, CO2 measurement will be performed in several relevant sectors (classrooms, amphitheaters, corridors etc) to allow a more holistic understanding of the propagation conditions. Finally, the probabilistic models will be confronted to the results of a two step COVID-19 screening campaign.
- Conditions
- Covid19
- Being tested
- Antigenic tests (on saliva samples), Individual electronic sensor port, Atmospheric measurements of CO2
- Keywords
- Simulation, epidemiology, public health, computer science, infectiology, technology, pandemic COVID
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antigenic tests (on saliva samples)Other
SARS-CoV-2 screening tests: two massive antigenic tests campaigns (on salivary samples).
Individual electronic sensor portOther
Individual electronic sensor recording contacts but not their location (in the form of a bracelet, a key ring or a badge) Contact data collection points (5 maximum, located at compulsory passage points for participants). When a sensor is close to one of these terminals, it discharges its contacts in seconds.
Atmospheric measurements of CO2Other
Atmospheric measurements of CO2 in the relevant closed places of the faculty (lectures / practical work / BU / refectory): battery operated sensors. When a sensor is installed in a place, the ventilation conditions (number of open windows, etc.) as well as the number of people present will be noted.
| Study group | Role | What they receive |
|---|---|---|
| Students, teachers,administrative staff from the medical school of Paris-Saclay University | Experimental | Students,teachers,administrative staff from the medical school of Paris-Saclay University Receives: Other: Antigenic tests (on saliva samples); Other: Individual electronic sensor port; Other: Atmospheric measurements of CO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulations results compared with the COVID-19 two-step screening campaign results
Develop and validate a simulation tool for the spread of an epidemic in a university-type environment, updated by the effective measurement of contacts between individuals (wireless digital search of contacts).
Measured: 2 months
Secondary outcomes (1)
CO2 atmospheric measurement
The CO2 rate will be measured under very diverse conditions in terms of room size, number of people, type of ventilation. These systematic measurements together with the reading of precise conditions will allow us to establish a precise correspondence between the various factors and this rate. This should improve our understanding of the chains of contamination. and the circumstances that may have favored the spread of the disease.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start14 Oct 2021
- Primary completion15 Dec 2021
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier LAMBOTTE, Pr, Principal investigator, Bicetre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991246
- Sponsor's protocol ID
- APHP210403
- Other IDs
- 2021-A00663-38
- Acronym
- FLUCOVID
- Status last verified
- Nov 2022
- First submitted
- 5 Jul 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project FLUx COntact-CoVID-19 Faculty of Medicine Paris-Saclay
- ClinicalTrials.gov ID
- NCT04991246
- Acronym / sponsor ID
- FLUCOVID / APHP210403
- Conditions
- Covid19
- Keywords
- Simulation, epidemiology, public health, computer science, infectiology, technology, pandemic COVID
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 5 Aug 2021 (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 worldwide health system has been marked by the SARS-CoV-2 pandemic. French educational system has been upset, especially medical schools, which, because of their hospital location, are particularly exposed to the spread of the virus. The medical school of Paris-Saclay University, located within bicetre University Hospital, AP-HP, must therefore adapt on a daily basis to ensure educational continuity. Taking advantage of an exceptional scientific ecosystem, innovative viral epidemic propagation modeling approaches based on both simulation and contact tracing data will be tested in real-life conditions. These propagation models will serve to scientifically optimize future educational organization procedures in this medical school.
Detailed description
All the participants will be equipped with individual wireless contact tracing technology. Anonymised contact events will be automatically monitored for a period of two months to measure the daily contact flow density between the students at medical school. Epidemic simulation models will be enriched with these real contact tracing data to generate optimized viral propagation probability networks. During the same period, CO2 measurement will be performed in several relevant sectors (classrooms, amphitheaters, corridors etc) to allow a more holistic understanding of the propagation conditions. Finally, the probabilistic models will be confronted to the results of a two step COVID-19 screening campaign.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Students, teachers,administrative staff from the medical school of Paris-Saclay University | Experimental | Other: Antigenic tests (on saliva samples), Other: Individual electronic sensor port, Other: Atmospheric measurements of CO2Students,teachers,administrative staff from the medical school of Paris-Saclay University |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteers of adult men and women over 18 from the Paris-Saclay Medicine UFR
- Affiliated to a social security scheme or beneficiary (excluding AME)
- Informed and written consent
Key exclusion criteria (2 listed)
- Absence of intercurrent disease before inclusion
- Positive antigenic or PCR test at the time of inclusion
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 |
|---|---|---|
| Antigenic tests (on saliva samples)SARS-CoV-2 screening tests: two massive antigenic tests campaigns (on salivary samples). | Other | Students, teachers,administrative staff from the medical school of Paris-Saclay University |
| Individual electronic sensor portIndividual electronic sensor recording contacts but not their location (in the form of a bracelet, a key ring or a badge) Contact data collection points (5 maximum, located at compulsory passage points for participants). When a sensor is close to one of these terminals, it discharges its contacts in seconds. | Other | Students, teachers,administrative staff from the medical school of Paris-Saclay University |
| Atmospheric measurements of CO2Atmospheric measurements of CO2 in the relevant closed places of the faculty (lectures / practical work / BU / refectory): battery operated sensors. When a sensor is installed in a place, the ventilation conditions (number of open windows, etc.) as well as the number of people present will be noted. | Other | Students, teachers,administrative staff from the medical school of Paris-Saclay University |
Primary outcome
Simulations results compared with the COVID-19 two-step screening campaign results
Time frame: 2 months
Develop and validate a simulation tool for the spread of an epidemic in a university-type environment, updated by the effective measurement of contacts between individuals (wireless digital search of contacts).
1 secondary outcome
CO2 atmospheric measurement
Time frame: 2 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 6 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Olivier LAMBOTTE, Pr principal investigator
Bicetre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antigenic tests (on saliva samples), Individual electronic sensor port and Atmospheric measurements of CO2 in people with Covid19, run by Assistance Publique - Hôpitaux de Paris 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 6 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 6 Feb 2023. 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?
Simulations results compared with the COVID-19 two-step screening campaign results (time frame: 2 months). 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 6 Feb 2023.