Transmission of Covid-19 During Clubbing Events in Closed Places

NCT05311865 | Completed

• 1 other identifier: ANRS0066s
• Study Type: interventional
• Target: 1,216
• Locations: 1 country
• Sites: 1

Brief Summary

The ITOC study is a cluster randomised, controlled, multicentre trial in Paris region, France. The intervention is an 8-hour indoor clubbing event with no mask wearing, no social distancing, at maximum room capacity. 1,200 healthy volunteers aged 18-49 years and fully vaccinated will be included. Participants are recruited by group of up to 10, to be randomized 2:1 to experimental group (800 volunteers in a venue ) or control group (400 volunteers asked to stay at home). All participants will provide a salivary sample the day of experiment and seven days later. Participants will also answer surveys on the social and psychological impact of lockdown and indoor club closing, attitude towards vaccination, behaviour at risk of COVID-19 transmission during the day of the event (for both groups) as well as follow-up surveys on symptoms that participant may experience. Virological analyses include polymerase chain reaction (PCR) of salivary samples and air of the venue, investigating SARS-CoV-2 PCR.

Conditions

Healthy Participant

Keywords

SARS CoV-2; Transmission; vaccinated; Night-club

Outcome Measures

Primary Outcomes (1)

• Number of positive RT-PCR at day 7

  Number of participants in each groups with a positive salivary RT-PCR

  Day 7

Secondary Outcomes (9)

• Number of SARS-CoV-2 infection cases

  Day 5 up to day 10

• Number of participants with seasonal respiratory viruses

  Day 0 and day 7

• Number of symptomatic and asymptomatic respiratory infection

  Day 5 to day 10

• Number of detected virus in the air

  Day 0

• Number of mutations, deletions and insertions on the viral genome in participants samples

  Day 0 and day 7

Study Arms (2)

participating to the event

EXPERIMENTAL

Other: Club event

Non partipating to the event

NO INTERVENTION

Interventions

Club event OTHER

Participate in a club event without a mask, indoors, with vaccinated people.

participating to the event

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 49 years old
• Vaccination completed
• People who declared to have no risk factor to severe form for Covid-19 disease
• People who declared not to live in the same place as someone with these risk factors
• People residing in Ile-de-France area
• People affiliated with the the French social security citizen scheme

You may not qualify if:

• Presence of symptoms of COVID in the 2 weeks before the event
• Pregnant woman or woman who declares not having an effective contraception method
• Self identification of medical conditions or comorbidities identified as a proven risk of severe COVID infection
• People living with a person with these risk factors
• Confirmed diagnosis of SARS-CoV-2 within two weeks before the event
• Participants under tutorship or curatorship;
• Underage participants;
• Participants unable to give free and informed consent;
• Participants not affiliated to the French social security citizen scheme: obligation to join a social security scheme or be a beneficiary thereof.
• Participants under legal protection

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Cerballiance: collaborator
• Kappa Santé: collaborator

Study Sites (1)

ANRS

Paris, 75013, France

Location

Related Publications (2)

• Luong Nguyen LB, Goupil de Bouille J, Menant L, Noret M, Dumas A, Salmona M, Le Goff J, Delaugerre C, Crepey P, Zeggagh J; ITOC Study Group. A Randomized Controlled Trial to Study the Transmission of SARS-CoV-2 and Other Respiratory Viruses During Indoor Clubbing Events (ANRS0066s ITOC Study). Clin Infect Dis. 2023 Dec 15;77(12):1648-1655. doi: 10.1093/cid/ciad603.

  PMID: 37795682 DERIVED

• Goupil de Bouille J, Luong Nguyen LB, Crepey P, Garlantezec R, Dore V, Dumas A, Ben Mechlia M, Tattevin P, Gaudart J, Spire B, Lert F, Yazdanpanah Y, Delaugerre C, Noret M, Zeggagh J. Transmission of SARS-CoV-2 during indoor clubbing events: A clustered randomized, controlled, multicentre trial protocol. Front Public Health. 2022 Nov 4;10:981213. doi: 10.3389/fpubh.2022.981213. eCollection 2022.

  PMID: 36438274 DERIVED

Study Officials

• Yazdan Yazdanpanah, Pr

  ANRS, Emerging Infectious Diseases

  STUDY DIRECTOR

Study Design

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

Model Details: Open-label, multicenter, randomized controlled intervention study with 1200 participants distributed 2: 1 in two groups of volunteers.

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 5, 2022
• Study Start: September 4, 2021
• Primary Completion: October 17, 2021
• Study Completion: February 26, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-04

Locations

FR (1)