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OpenTrials
Completed

NCT Number: NCT04872075

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AccorHotels Arena

Paris, 75012, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Concert

Other

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

Rapid nasopharyngeal antigen test for Sars-Cov-2

Diagnostic Test

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

Saliva sample

Diagnostic Test

Saliva samples sent by participant at Day0 and Day7

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • PRODISS
  • URC-CIC Paris Descartes Necker Cochin
  • WEEZEVENT

Registry information

Acronym: SPRING

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 4, 2021
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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