NCT05311865|Completed
Transmission of Covid-19 During Clubbing Events in Closed Places
ITOC
Loading search results
ITOC
Sponsor study identifier
interventional
1,216
1 country
1
Study Start
September 4, 2021
Actual (reported)Primary Completion
October 17, 2021
Actual (reported)Study Completion
February 26, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 26, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 4, 2021
Actual (reported)October 17, 2021
Actual (reported)February 26, 2022
Actual (reported)March 8, 2022
Actual (reported)April 5, 2022
Actual (reported)Number of positive RT-PCR at day 7
Number of participants in each groups with a positive salivary RT-PCR
Day 7
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
Participate in a club event without a mask, indoors, with vaccinated people.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
ANRS
Paris, 75013, France
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.
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.
Yazdan Yazdanpanah, Pr
ANRS, Emerging Infectious Diseases
1,216 participants (actual enrollment reported by the registry).
First Submitted
March 8, 2022
First Posted
April 5, 2022
Study Start
September 4, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 17, 2021
Actual (reported)Study Completion
February 26, 2022
Actual (reported)Last Updated
April 5, 2022
Record last verified: 2022-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: