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

Covid19 Clinical Trial

— SPRING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04872075
• Other study ID #: APHP210504
• Secondary ID: 2021-A01264-37
• Status: Completed
• Phase: N/A
• Start date: May 26, 2021
• Est. completion date: June 13, 2021

Study information

• Verified date: July 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6678
• Est. completion date: June 13, 2021
• Est. primary completion date: June 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• Concert
People attending a concert in a closed area, with a mask

Diagnostic Test:
• Rapid nasopharyngeal antigen test for Sars-Cov-2
A nasopharyngeal swab at inclusion (up to 3 days before concert) to confirm eligibility
• Saliva Sample
Saliva samples sent by participant at Day0 and Day7

Locations

Country	Name	City	State
France	AccorHotels Arena	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	PRODISS, WEEZEVENT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a positive salivary RT-PCR at day 7 after the date of the concert	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)	7 days after the concert (-1/+8 days)
Secondary	Number of participants in each group with a positive salivary RT-PCR 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	The day of the concert
Secondary	Molecular analysis of transmission clusters	Comparison of the sequence of complete viral genome in participant with a positive test at day 7	7 days after the concert (-1/+8 days)
Secondary	Average percentage of participants wearing their mask adequately for the duration of event	Estimate the overall compliance of the mask wearing by the participants during the duration of the event (covering nose and mouth)	The day of the concert
Secondary	Percentage of adequate mask wearing among participants according to location and time	Identify the circumstances (place, time) of failure of accurate mask wearing by the participants	The day of the concert
Secondary	Percentage of participants who downloaded and / or used the TousAntiCovid application at the time of inclusion	Estimate the feasibility and acceptability of using the Tousanticovid application	The day of the concert