A Randomized Controlled Trial to Study the Transmission of SARS-CoV-2 and Other Respiratory Viruses During Indoor Clubbing Events (ANRS0066s ITOC Study).

Background: In the context of the circulation of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) B.1.617.2 (Delta) variant, vaccination re-authorized mass indoor gatherings. The "Indoor Transmission of coronavirus disease 2019 (COVID-19)" (ITOC) trial (ClinicalTrials.gov, NCT05311865) aimed to assess the risk of transmission of SARS-CoV-2 and other respiratory viruses during an indoor clubbing event among participants fully vaccinated against COVID-19.

Methods: ITOC, a randomized controlled trial in the Paris region (France), enrolled healthy volunteers aged 18-49 years, fully vaccinated against COVID-19, with no comorbidities or symptoms, randomized 1:1 to be interventional group "attendees" or control "non-attendees." The intervention was a 7-hour indoor event in a nightclub at full capacity, with no masking, prior SARS-CoV-2 test result, or social distancing required. The primary outcome measure was the number of reverse transcriptase-polymerase chain reaction (RT-PCR)-determined SARS-CoV-2-positive subjects using self-collected saliva 7 days post-gathering in the per-protocol population. Secondary endpoints focused on 20 other respiratory viruses.

Results: Healthy participants (n = 1216) randomized 2:1 by blocks up to 10 815 attendees and 401 non-attendees, yielding 529 and 287 subjects, respectively, with day-7 saliva samples. One day-7 sample from each group was positive. Looking at all respiratory viruses together, the clubbing event was associated with an increased risk of infection of 1.59 (95% CI, 1.04-2.61).

Conclusions: In the context of low Delta variant of concern circulation, no evidence of SARS-CoV-2 transmission among asymptomatic and vaccinated participants was found, but the risk of other respiratory virus transmission was higher. Clinical Trials Registration. ClinicalTrials.gov, NCT05311865.