NCT04896970

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Status
withdrawn

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

May 11, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

1 month

First QC Date

May 11, 2021

Last Update Submit

October 18, 2021

Conditions

SARS-CoV-2

Keywords

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • SARS-CoV-2 incidence

    Rate of newly SARS-CoV-2 infected participants

    7 days after the first screening

Secondary Outcomes (1)

  • Time to screen all participants

    At screening day

Study Arms (2)

Concert

EXPERIMENTAL

Participants will go to a concert in a closed hall.

Other: Concert

Control

NO INTERVENTION

Participant will stay at home.

Interventions

ConcertOTHER

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.

Concert

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

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

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 21, 2021

Study Start

June 1, 2021

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

October 20, 2021

Record last verified: 2021-10