NCT04991246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 14, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2022

Completed
Last Updated

February 6, 2023

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

July 5, 2021

Last Update Submit

February 3, 2023

Conditions

Keywords

Simulationepidemiologypublic healthcomputer scienceinfectiologytechnologypandemic COVID

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • CO2 atmospheric measurement

    2 months

Study Arms (1)

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

Other: Antigenic tests (on saliva samples)Other: Individual electronic sensor portOther: Atmospheric measurements of CO2

Interventions

SARS-CoV-2 screening tests: two massive antigenic tests campaigns (on salivary samples).

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

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.

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

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.

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Olivier LAMBOTTE, Pr

    Bicetre Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2021

First Posted

August 5, 2021

Study Start

October 14, 2021

Primary Completion

December 15, 2021

Study Completion

January 14, 2022

Last Updated

February 6, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations