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.
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;
Show all 10Show fewer
- 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.
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.
- Conditions
- Healthy Participant
- 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 group | Role | What they receive |
|---|---|---|
| participating to the event | Experimental | Not described Receives: Other: Club event |
| Non partipating to the event | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
Number of detected virus in the air
Number of detected virus in the air, by the AerosolSense
Measured: Day 0
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
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
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
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
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.
- First posted5 Apr 2022
- Study start4 Sep 2021
- Primary completion17 Oct 2021
- Study completion26 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Cerballiance, Kappa Santé
- Responsible party
- Sponsor
- Investigators
- Yazdan Yazdanpanah, Pr, Study director, ANRS, Emerging Infectious Diseases
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 37795682Goupil 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transmission of Covid-19 During Clubbing Events in Closed Places
- ClinicalTrials.gov ID
- NCT05311865
- Acronym / sponsor ID
- ITOC / ANRS0066s
- Conditions
- Healthy Participant
- Keywords
- SARS CoV-2, Transmission, vaccinated, Night-club
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,216 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Cerballiance, Kappa Santé
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 17 Oct 2021 (actual)
- Study completion
- 26 Feb 2022 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, multicenter, randomized controlled intervention study with 1200 participants distributed 2: 1 in two groups of volunteers.
| Arm | Type | Receives |
|---|---|---|
| participating to the event | Experimental | Other: Club event |
| Non partipating to the event | No intervention | – |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Club eventParticipate in a club event without a mask, indoors, with vaccinated people. | Other | participating to the event |
Primary outcome
Number of positive RT-PCR at day 7
Time frame: Day 7
Number of participants in each groups with a positive salivary RT-PCR
9 secondary outcomes
Number of SARS-CoV-2 infection cases
Time frame: Day 5 up to day 10
Number of participants with seasonal respiratory viruses
Time frame: Day 0 and day 7
Number of symptomatic and asymptomatic respiratory infection
Time frame: Day 5 to day 10
Number of detected virus in the air
Time frame: Day 0
Number of mutations, deletions and insertions on the viral genome in participants samples
Time frame: Day 0 and day 7
Number of mutations, deletions and insertions on the viral genome in Aerosol samples
Time frame: Day 0 and day 7
Percentage of divergence between phylogenetic analysis of participants and aerosol samples
Time frame: Day 0 and day 7
Percentage of Health protocol adherence
Time frame: Day 1
Percentage of Interactions between the participants during the event
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Derived from this study: PubMed 37795682Luong 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.
- Derived from this study: PubMed 36438274Goupil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yazdan Yazdanpanah, Pr study director
ANRS, Emerging Infectious Diseases
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.