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Project FLUx COntact-CoVID-19 Faculty of Medicine Paris-Saclay (FLUCOVID)

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Antigenic tests (on saliva samples)
Individual electronic sensor port
Atmospheric measurements of CO2
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Covid19 focused on measuring Simulation, epidemiology, public health, computer science, infectiology, technology, pandemic COVID

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Bicêtre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Students, teachers,administrative staff from the medical school of Paris-Saclay University

Arm Description

Students,teachers,administrative staff from the medical school of Paris-Saclay University

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
July 5, 2021
Last Updated
February 3, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04991246
Brief Title
Project FLUx COntact-CoVID-19 Faculty of Medicine Paris-Saclay
Acronym
FLUCOVID
Official Title
Project FLUx COntact-CoVID-19 Faculty of Medicine Paris-Saclay
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 14, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
January 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Simulation, epidemiology, public health, computer science, infectiology, technology, pandemic COVID

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Students, teachers,administrative staff from the medical school of Paris-Saclay University
Arm Type
Experimental
Arm Description
Students,teachers,administrative staff from the medical school of Paris-Saclay University
Intervention Type
Other
Intervention Name(s)
Antigenic tests (on saliva samples)
Intervention Description
SARS-CoV-2 screening tests: two massive antigenic tests campaigns (on salivary samples).
Intervention Type
Other
Intervention Name(s)
Individual electronic sensor port
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Atmospheric measurements of CO2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Simulations results compared with the COVID-19 two-step screening campaign results
Description
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).
Time Frame
2 months
Secondary Outcome Measure Information:
Title
CO2 atmospheric measurement
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier LAMBOTTE, Pr
Organizational Affiliation
Bicetre Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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