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

February 3, 2023 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Kremlin-Bicêtre, France, 94270
        • CHU Bicêtre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Students, teachers,administrative staff from the medical school of Paris-Saclay University
Students,teachers,administrative staff from the medical school of Paris-Saclay University
Other: Antigenic tests (on saliva samples)
SARS-CoV-2 screening tests: two massive antigenic tests campaigns (on salivary samples).
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CO2 atmospheric measurement
Time Frame: 2 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Olivier LAMBOTTE, Pr, Bicetre Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 14, 2021

Primary Completion (ACTUAL)

December 15, 2021

Study Completion (ACTUAL)

January 14, 2022

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

July 31, 2021

First Posted (ACTUAL)

August 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210403
  • 2021-A00663-38 (OTHER: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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