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Completed

NCT Number: NCT05311865

Transmission of Covid-19 During Clubbing Events in Closed Places

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.

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Key information

Conditions

Healthy Participant

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ANRS

Paris, 75013, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Club event

Other

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

Primary outcomes

  1. Number of positive RT-PCR at day 7

    Time frame: Day 7

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

Secondary outcomes

  1. Number of SARS-CoV-2 infection cases

    Time frame: Day 5 up to day 10

    Numbers of asymptomatic, symptomatic, and severe SARS-CoV-2 infection according to a self-assessment by a questionnaire sent online in each group

  2. Number of participants with seasonal respiratory viruses

    Time frame: Day 0 and day 7

    Number of participants in each group with a positive seasonal respiratory viruses PCR

  3. Number of symptomatic and asymptomatic respiratory infection

    Time frame: Day 5 to day 10

    Numbers of asymptomatic, symptomatic, and severe seasonal respiratory viruses infection according to a self-assessment by a questionnaire sent online

  4. Number of detected virus in the air

    Time frame: Day 0

    Number of detected virus in the air, by the AerosolSense

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

    Time frame: Day 0 and day 7

    Whole genome sequencing of virus detected in participants samples : number of mutations, deletions or insertions on all the viral genes of consensus sequences

  6. Number of mutations, deletions and insertions on the viral genome in Aerosol samples

    Time frame: Day 0 and day 7

    Whole genome sequencing of virus detected in Aerosol samples : number of mutations, deletions or insertions on all the viral genes of consensus sequences

  7. Percentage of divergence between phylogenetic analysis of participants and aerosol samples

    Time frame: Day 0 and day 7

    Establishing the distance matrix between the viruses in participants samples and viruses detected by aerosol sense

  8. Percentage of Health protocol adherence

    Time frame: Day 1

    Percentage of positive responses to a questionnaire assessing degree of adherence to the health protocol by questionnaire sent online to participants and organizers after the evenings.

  9. Percentage of Interactions between the participants during the event

    Time frame: Day 1

    Percentage of responses to a questionnaire assessing number of individual interactions during the event

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Cerballiance
  • Kappa Santé

Registry information

Acronym: ITOC

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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