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Risk of SARS-CoV-2 Infection (COVID-19) in a Standing Concert in a Closed Performance Hall (ConcerTest)

Primary Purpose

SARS-CoV-2

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Concert
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for SARS-CoV-2 focused on measuring SARS-CoV-2

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • At least 18 and less than 60 years old
  • Having completed the internet pre selection questionnaire and signed the consent form
  • Negative rapid saliva RT-LAMP EasyCov test on the day of the show
  • Social Security Affiliation

Exclusion criteria:

  • Serious form Covid-19 risk factors
  • Positive saliva rapid test on the day of the event (and people who came with a positive person)
  • History of SARS-CoV-2
  • SARS-CoV-2 vaccination
  • Living with a person older than 75 years old or having a serious form of Covid-19 risk factor
  • Protection of a legal conservator
  • Pregnant or breastfeeding women
  • People living with a pregnant or breastfeeding woman

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Concert

    Control

    Arm Description

    Participants will go to a concert in a closed hall.

    Participant will stay at home.

    Outcomes

    Primary Outcome Measures

    SARS-CoV-2 incidence
    Rate of newly SARS-CoV-2 infected participants

    Secondary Outcome Measures

    Time to screen all participants
    time spent to screen and have results for every participant of the concert

    Full Information

    First Posted
    May 11, 2021
    Last Updated
    October 18, 2021
    Sponsor
    University Hospital, Montpellier
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04896970
    Brief Title
    Risk of SARS-CoV-2 Infection (COVID-19) in a Standing Concert in a Closed Performance Hall
    Acronym
    ConcerTest
    Official Title
    Risk of SARS-CoV-2 Infection in a Standing Concert in a Closed Performance Hall
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    abandonment
    Study Start Date
    June 2021 (Anticipated)
    Primary Completion Date
    July 2021 (Anticipated)
    Study Completion Date
    July 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators want to compare the SARS-CoV-2 incidence 7 days after having been screened negative, between two groups of adults randomized to either go to a concert or not. Participants will be screened via a rapid saliva test a few hours before the show. The hypothesis is that attending a standing concert in respect of safety precaution doesn't increase the risk of SARS-CoV-2 infection.
    Detailed Description
    Context : A previous Spanish randomized study in November 2020 concluded in a non superiority of the SARS-CoV-2 incidence in RT-PCR-negative participant of a concert compared to a control group. In the same way, investigators want to compare the SARS-CoV-2 incidence of participants of a concert 7 days after the show with a control group, using a saliva test. While naso-pharyngeal RT-CPR is the gold-standard for virological SARS-COV-2 tests, this method can be painful and results take time. Saliva rapid tests have satisfactory diagnostic performances and easy access to results. Saliva rapid tests may lead to mass screening in cultural mass events. This project has the specific feature to be set in closed concert hall with limited size attendance. Methodology : This experimental monocentric randomized non-inferiority will compare 2 parallel groups (with single blind for the screening tests results). The randomization will be centralised and stratified on the age. Program : Participants will be informed via an information notice and a preselection screening questionnaire on the internet. Eligible participants will have to come on the day of the show near the concert place to be included (after information and signing of the consent form). participants will receive a saliva sample tube. Positively screened participants will have to go home. The others will be randomized in two groups. Participants will both have to come back 7 days after for the second screening. Feasibility : The concert place have a strong fan base to recruit participants from. To include all the participants, two concerts will take place, separated by a few days. Participants will receive goodies to maximize the chance of them attending to both screening. This project received a methodological support from the Clinical and Epidemiological Research Unit of the Montpellier Hospital and is promoted by the Montpellier Hospital. Sys2diag and SkillCell which developed the screening tests are involved as well as VOGO for the technical part and data management. This project is financially helped by Région Occitanie, Montpellier Métropole, Saint-Jean-de-Vedas, SACEM, APEM, Tout à Fond and Boomerang.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    SARS-CoV-2
    Keywords
    SARS-CoV-2

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Concert
    Arm Type
    Experimental
    Arm Description
    Participants will go to a concert in a closed hall.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Participant will stay at home.
    Intervention Type
    Other
    Intervention Name(s)
    Concert
    Intervention Description
    A musical show in a closed hall, lasting for about 2 hours, in respects of safety measure (masks, hydroalcoholic gel, etc…) with approximately 200 participants.
    Primary Outcome Measure Information:
    Title
    SARS-CoV-2 incidence
    Description
    Rate of newly SARS-CoV-2 infected participants
    Time Frame
    7 days after the first screening
    Secondary Outcome Measure Information:
    Title
    Time to screen all participants
    Description
    time spent to screen and have results for every participant of the concert
    Time Frame
    At screening day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: At least 18 and less than 60 years old Having completed the internet pre selection questionnaire and signed the consent form Negative rapid saliva RT-LAMP EasyCov test on the day of the show Social Security Affiliation Exclusion criteria: Serious form Covid-19 risk factors Positive saliva rapid test on the day of the event (and people who came with a positive person) History of SARS-CoV-2 SARS-CoV-2 vaccination Living with a person older than 75 years old or having a serious form of Covid-19 risk factor Protection of a legal conservator Pregnant or breastfeeding women People living with a pregnant or breastfeeding woman

    12. IPD Sharing Statement

    Learn more about this trial

    Risk of SARS-CoV-2 Infection (COVID-19) in a Standing Concert in a Closed Performance Hall

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