NCT04872075

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,678

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started May 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

April 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

May 26, 2021

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2021

Completed
Last Updated

November 20, 2025

Status Verified

September 1, 2025

Enrollment Period

18 days

First QC Date

April 29, 2021

Last Update Submit

November 17, 2025

Conditions

Covid19

Keywords

Sars-Cov-2Covid-19ScreeningConcertClosed areaStanding configuration

Outcome Measures

Primary Outcomes (1)

  • Number of participants with a positive salivary RT-PCR at day 7 after the date of the concert

    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 Outcomes (5)

  • Number of participants in each group with a positive salivary RT-PCR the day of the concert

    The day of the concert

  • Molecular analysis of transmission clusters

    7 days after the concert (-1/+8 days)

  • Average percentage of participants wearing their mask adequately for the duration of event

    The day of the concert

  • Percentage of adequate mask wearing among participants according to location and time

    The day of the concert

  • Percentage of participants who downloaded and / or used the TousAntiCovid application at the time of inclusion

    The day of the concert

Study Arms (2)

Experimental

EXPERIMENTAL

People at the concert

Other: ConcertDiagnostic Test: Rapid nasopharyngeal antigen test for Sars-Cov-2Diagnostic Test: Saliva Sample

Control

ACTIVE COMPARATOR

People staying at home

Diagnostic Test: Rapid nasopharyngeal antigen test for Sars-Cov-2Diagnostic Test: Saliva Sample

Interventions

ConcertOTHER

People attending a concert in a closed area, with a mask

Experimental
Rapid nasopharyngeal antigen test for Sars-Cov-2DIAGNOSTIC_TEST

A nasopharyngeal swab at inclusion (up to 3 days before concert) to confirm eligibility

ControlExperimental
Saliva SampleDIAGNOSTIC_TEST

Saliva samples sent by participant at Day0 and Day7

ControlExperimental

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AccorHotels Arena

Paris, 75012, France

Location

Related Publications (1)

  • Delaugerre C, Foissac F, Abdoul H, Masson G, Choupeaux L, Dufour E, Gastli N, Delarue SM, Nere ML, Minier M, Gabassi A, Salmona M, Seguineau M, Schmitt S, Tonglet S, Olivier A, Poyart C, Le Goff J, Lescure X, Kerneis S, Treluyer JM; SPRING study group. Prevention of SARS-CoV-2 transmission during a large, live, indoor gathering (SPRING): a non-inferiority, randomised, controlled trial. Lancet Infect Dis. 2022 Mar;22(3):341-348. doi: 10.1016/S1473-3099(21)00673-3. Epub 2021 Nov 26.

    PMID: 34843662RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Constance DELAUGERRE, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 4, 2021

Study Start

May 26, 2021

Primary Completion

June 13, 2021

Study Completion

June 13, 2021

Last Updated

November 20, 2025

Record last verified: 2025-09

Locations

FR(1)