Project FLUx COntact-CoVID-19 Faculty of Medicine Paris-Saclay

Covid19 Clinical Trial

— FLUCOVID  

Official title:

Project FLUx COntact-CoVID-19 Faculty of Medicine Paris-Saclay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04991246
• Other study ID #: APHP210403
• Secondary ID: 2021-A00663-38
• Status: Completed
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: January 14, 2022

Study information

• Verified date: November 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: January 14, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Absence of intercurrent disease before inclusion

• Positive antigenic or PCR test at the time of inclusion

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Antigenic tests (on saliva samples)
SARS-CoV-2 screening tests: two massive antigenic tests campaigns (on salivary samples).
• Individual electronic sensor port
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 CO2
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.

Locations

Country	Name	City	State
France	CHU Bicêtre	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 months
Secondary	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.	2 months