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Healthy ParticipantITOCNCT05311865

Transmission of Covid-19 During Clubbing Events in Closed Places

A study testing Club event in people with Healthy Participant, run by ANRS, Emerging Infectious Diseases at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participant
What is being tested?
Club event
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,216 participants
Where
1 siteFrance
Study dates
4 Sep 2021to 26 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • ANRS

    Paris, 75013

Other trials in France

About this study

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.

Being tested
Club event
Keywords
SARS CoV-2, Transmission, vaccinated, Night-club

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Club eventOther

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

Study groups in NCT05311865
Study groupRoleWhat they receive
participating to the eventExperimentalNot described
Receives: Other: Club event
Non partipating to the eventNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of positive RT-PCR at day 7

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

    Measured: Day 7

Secondary outcomes (9)

  1. Number of SARS-CoV-2 infection cases

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

    Measured: Day 5 up to day 10

  2. Number of participants with seasonal respiratory viruses

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

    Measured: Day 0 and day 7

  3. Number of symptomatic and asymptomatic respiratory infection

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

    Measured: Day 5 to day 10

  4. Number of detected virus in the air

    Number of detected virus in the air, by the AerosolSense

    Measured: Day 0

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

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

    Measured: Day 0 and day 7

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

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

    Measured: Day 0 and day 7

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

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

    Measured: Day 0 and day 7

  8. Percentage of Health protocol adherence

    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.

    Measured: Day 1

  9. Percentage of Interactions between the participants during the event

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

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start4 Sep 2021
  3. Primary completion17 Oct 2021
  4. Study completion26 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label, multicenter, randomized controlled intervention study with 1200 participants distributed 2: 1 in two groups of volunteers.
Masking
None (open label)
Enrolment
1,216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05311865
Sponsor's protocol ID
ANRS0066s
Acronym
ITOC
Status last verified
Apr 2022
First submitted
8 Mar 2022
Last updated
5 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37795682

  • 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.

    PubMed 36438274

Questions about this trial

What is this clinical trial studying?

A study testing Club event in people with Healthy Participant, run by ANRS, Emerging Infectious Diseases at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of positive RT-PCR at day 7 (time frame: Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05311865, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.

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