Study on Prevention of SARS-CoV-2 Transmission During a Large Indoor Gathering Event (SPRING)

November 17, 2025 updated by: Assistance Publique - Hôpitaux de Paris

The objective is to demonstrate if there is no increase in the risk of Sars-Cov-2 salivary carriage 7 days after a concert in the group participating in the event compared to a non participating group who stayed at home.

The hypothesis is that a systematic screening of Sars-Cov-2 within the 3 days before the event allows to control the risk of transmission and prevent cluster of transmission during the concert.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before inclusion, the participants will be able to pre-register to the event via a website. They will get an appointment for an inclusion visit at the Accor Arena (Paris Bercy, France).

During 3 days (from D-3 to D-1), participants with a registration will come to the Accor Arena to have a rapid Sars-Cov-2 antigen test (results in 15 min).

If the test is positive, the participant will be contacted and managed by the medical team in charge of the national strategy for positives cases.

People with a negative test will be included and randomized :

  • Two kits with tube for collecting saliva samples (for D0 and D7) will be given to each participant at this visit
  • People randomized in the experimental group will receive their concert ticket at a later date.
  • At Day 0, people randomized in the experimental group, will come to the Accor Arena with their ticket to participate in the concert. At the entrance, they should give their D0 saliva sampling kit. The people randomized in the control group will stay at home and will send their D0 saliva sample by post mail.
  • At Day 7 (±1 day) all the participants must return their D7 saliva sampling kit via post mail

Study Type

Interventional

Enrollment (Actual)

6678

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
      • Paris, France, 75012
        • AccorHotels Arena

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • aged between 18 and 45 years old
  • lack of symptoms or no contact with people with Covid-19 in the last two weeks
  • negative antigenic test to Covid-19 in the 3 days before the experiment
  • people who declared to have no risk factor to severe form of Covid-19
  • people who declared not to live in the same place as someone with these risk factors
  • people residing in Ile-de-France area

Exclusion Criteria:

  • positive test to Sars-Cov-2 within 3 days before the concert
  • people with clinical signs suggesting infectious respiratory disease
  • people with severe Covid-19 risk factor
  • people living with someone having severe covid-19 risk factor
  • not affiliated to social security
  • people who cannot remain standing for the time of the experimentation (about 5 hours)
  • person under tutorship or curatorship
  • pregnant women or not having effective contraception method
  • breastfeeding women

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
People at the concert
Other: Concert
People attending a concert in a closed area, with a mask
Diagnostic test: Rapid nasopharyngeal antigen test for Sars-Cov-2
A nasopharyngeal swab at inclusion (up to 3 days before concert) to confirm eligibility
Diagnostic test: Saliva Sample
Saliva samples sent by participant at Day0 and Day7
Active Comparator: Control
People staying at home
Diagnostic test: Rapid nasopharyngeal antigen test for Sars-Cov-2
A nasopharyngeal swab at inclusion (up to 3 days before concert) to confirm eligibility
Diagnostic test: Saliva Sample
Saliva samples sent by participant at Day0 and Day7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with a positive salivary RT-PCR at day 7 after the date of the concert
Time Frame: 7 days after the concert (-1/+8 days)
Prove the lack of increase of salivary carriage risk of SARS-CoV-2 on day 7 in participants present at the concert (experimental group) compared to non-participants at the event (control group)
7 days after the concert (-1/+8 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants in each group with a positive salivary RT-PCR the day of the concert
Time Frame: The day of the concert
Evaluation of the salivary carriage on day 0 (the concert day) despite a negative test within 3 days before the event and the conversion rate of salivary carriage between D0 and D7
The day of the concert
Molecular analysis of transmission clusters
Time Frame: 7 days after the concert (-1/+8 days)
Comparison of the sequence of complete viral genome in participant with a positive test at day 7
7 days after the concert (-1/+8 days)
Average percentage of participants wearing their mask adequately for the duration of event
Time Frame: The day of the concert
Estimate the overall compliance of the mask wearing by the participants during the duration of the event (covering nose and mouth)
The day of the concert
Percentage of adequate mask wearing among participants according to location and time
Time Frame: The day of the concert
Identify the circumstances (place, time) of failure of accurate mask wearing by the participants
The day of the concert
Percentage of participants who downloaded and / or used the TousAntiCovid application at the time of inclusion
Time Frame: The day of the concert
Estimate the feasibility and acceptability of using the Tousanticovid application
The day of the concert

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin
PRODISS
WEEZEVENT

Investigators

  • Principal Investigator: Constance DELAUGERRE, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 26, 2021

Primary Completion (Actual)

June 13, 2021

Study Completion (Actual)

June 13, 2021

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210504
  • 2021-A01264-37 (Other Identifier: ID-RCB)

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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