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Withdrawn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
About this trial
This is an interventional health services research trial for SARS-CoV-2 focused on measuring SARS-CoV-2
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
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
NCT ID
NCT04896970
First Posted
May 11, 2021
Last Updated
October 18, 2021
Sponsor
University Hospital, Montpellier
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Withdrawn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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