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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04896970

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Days)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2	Other: Concert	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Risk of SARS-CoV-2 Infection in a Standing Concert in a Closed Performance Hall

Anticipated Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Concert Participants will go to a concert in a closed hall.	Other: Concert 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.
No Intervention: Control Participant will stay at home.

Arm

Intervention/Treatment

Experimental: Concert

Participants will go to a concert in a closed hall.

Other: Concert

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.

No Intervention: Control

Participant will stay at home.

Outcome Measures

Primary Outcome Measures

SARS-CoV-2 incidence [7 days after the first screening]
Rate of newly SARS-CoV-2 infected participants

Secondary Outcome Measures

Time to screen all participants [At screening day]
time spent to screen and have results for every participant of the concert

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT04896970

Other Study ID Numbers:

RECHMPL21_0110

First Posted:

May 21, 2021

Last Update Posted:

Oct 20, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Montpellier

SARS-CoV-2

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Oct 20, 2021