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SARS-CoV-2 transmission risk screening for safer social events: a non-randomised controlled study.

ABSTRACT: There is an ongoing debate on the implementation of the COVID-19 passport throughout Europe. We sought to build and test a feasible prevention strategy to ensure low SARS-CoV transmission risk in public events. We conducted a non-randomised controlled study. The intervention group obtained a confidential digital certificate of very low capacity for transmitting SARS-CoV-2 and attended socio-cultural events in Girona (Spain) between 1 April and 21 May 2021. The primary care services and a network of pharmacies cooperated in providing the certification. A group of non-attendees was randomly selected from pseudonymised health records as controls. We estimated the incidences of SARS-CoV-2 infection and recorded the challenges in the process. Follow-up was complete for 1351 participants, who were matched with 4050 controls. Mean age of the study population was 31.1 years, and 53% of participants were women. Incidence rates of SARS-CoV infection at 14 days in the group of attendees and non-attendees were 15.9 and 17.7 per 100,000 person-days, respectively; the difference between incidences was - 1.8 (95% CI - 22.8, 19.3). Implementation problems were minor, and 89.2% of respondents to a survey were satisfied with the process. The incidence rate of SARS-CoV-2 infection was not different in the intervention and control groups. These results are in favour of establishing a COVID-19 certificate to attend public events, and connote feasibility of implementation at a population level.

SUBMITTER: Ramos R

PROVIDER: S-EPMC9326423 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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SARS-CoV-2 transmission risk screening for safer social events: a non-randomised controlled study.

Ramos Rafel R Alves-Cabratosa Lia L Blanch Jordi J Pèlach Àlex À Albert Laura L Salomó Quirze Q Cabarrocas Sílvia S Comas-Cufí Marc M Martí-Lluch Ruth R Ponjoan Anna A Garcia-Gil Maria M de Cambra Salomé S d'Anta Albert A Balló Elisabet E Alum Albert A Aleixandre Rosa Núria RN

Scientific reports 20220727 1

There is an ongoing debate on the implementation of the COVID-19 passport throughout Europe. We sought to build and test a feasible prevention strategy to ensure low SARS-CoV transmission risk in public events. We conducted a non-randomised controlled study. The intervention group obtained a confidential digital certificate of very low capacity for transmitting SARS-CoV-2 and attended socio-cultural events in Girona (Spain) between 1 April and 21 May 2021. The primary care services and a network ...[more]

PMID: 35896583

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Project description:BackgroundMass indoor gatherings were banned in early 2020 to prevent the spread of SARS-CoV-2. We aimed to assess, under controlled conditions, whether infection rates among attendees at a large, indoor gathering event would be similar to those in non-attendees, given implementation of a comprehensive prevention strategy including antigen-screening within 3 days, medical mask wearing, and optimised ventilation.MethodsThe non-inferiority, prospective, open-label, randomised, controlled SPRING trial was done on attendees at a live indoor concert held in the Accor Arena on May 29, 2021 in Paris, France. Participants, aged 18-45 years, recruited via a dedicated website, had no comorbidities, COVID-19 symptoms, or recent case contact, and had had a negative rapid antigen diagnostic test within 3 days before the concert. Participants were randomly allocated in a 2:1 ratio to the experimental group (attendees) or to the control group (non-attendees). The allocation sequence was computer-generated by means of permuted blocks of sizes three, six, or nine, with no stratification. The primary outcome measure was the number of patients who were SARS-CoV-2-positive by RT-PCR test on self-collected saliva 7 days post-gathering in the per-protocol population (non-inferiority margin <0·35%). This trial is registered with ClinicalTrials.gov, NCT04872075.FindingsBetween May 11 and 25, 2021, 18 845 individuals registered on the dedicated website, and 10 953 were randomly selected for a pre-enrolment on-site visit. Among 6968 who kept the appointment and were screened, 6678 participants were randomly assigned (4451 were assigned to be attendees and 2227 to be non-attendees; median age 28 years; 59% women); 88% (3917) of attendees and 87% (1947) of non-attendees complied with follow-up requirements. The day 7 RT-PCR was positive for eight of the 3917 attendees (observed incidence, 0·20%; 95% CI 0·09-0·40) and three of the 1947 non-attendees (0·15%; 0·03-0·45; absolute difference, 95% CI -0·26% to 0·28%), findings that met the non-inferiority criterion for the primary endpoint.InterpretationParticipation in a large, indoor, live gathering without physical distancing was not associated with increased SARS-CoV-2-transmission risk, provided a comprehensive preventive intervention was implemented.FundingFrench Ministry of Health.TranslationFor the French translation of the abstract see Supplementary Materials section.

Project description:IntroductionThe SARS-CoV-2 pandemic led to the implementation of several non-pharmaceutical interventions (NPIs), from closings of bars and restaurants to curfews and lockdowns. Vaccination campaigns started hoping it could efficiently alleviate NPI. The primary objective of the "Indoor Transmission of COVID-19" (ITOC) study is to determine among a fully vaccinated population the relative risk of SARS-CoV-2 transmission during one indoor clubbing event. Secondary objectives are to assess the transmission of other respiratory viruses, risk exposure, and attitudes toward COVID-19 vaccination, health pass, and psychological impact of indoor club closing.Methods and analysisFour thousand four hundred healthy volunteers aged 18-49 years and fully vaccinated will be included in Paris region. The intervention is an 8-hour indoor clubbing event with no masks, no social distance, maximum room capacity, and ventilation. A reservation group of up to 10 people will recruit participants, who will be randomized 1:1 to either the experimental group (2,200 volunteers in two venues with capacities of 1,000 people each) or the control group (2,200 volunteers asked not to go to the club). All participants will provide a salivary sample on the day of the experiment and 7 days later. They also will answer several questionnaires. Virological analyses include polymerase chain reaction (PCR) of salivary samples and air of the venue, investigating SARS-CoV-2 and 18 respiratory viruses.Ethics and disseminationEthical clearance was first obtained in France from the institutional review board (Comité de Protection des Personnes Ile de France VII - CPP), and the trial received clearance from the French National Agency for Medicines and Health Products (Agence National de Sécurité du Médicament - ANSM). The trial is supported and approved by The Agence Nationale Recherche sur le SIDA, les hépatites et maladies émergences (ANRS-MIE). Positive, negative, and inconclusive results will be published in peer-reviewed scientific journals.Trial registration numberIDR-CB 2021-A01473-38. Clinicaltrial.gov, identifier: NCT05311865.

Project description:BackgroundThe banning of mass-gathering indoor events to prevent SARS-CoV-2 spread has had an important effect on local economies. Despite growing evidence on the suitability of antigen-detecting rapid diagnostic tests (Ag-RDT) for mass screening at the event entry, this strategy has not been assessed under controlled conditions. We aimed to assess the effectiveness of a prevention strategy during a live indoor concert.MethodsWe designed a randomised controlled open-label trial to assess the effectiveness of a comprehensive preventive intervention for a mass-gathering indoor event (a live concert) based on systematic same-day screening of attendees with Ag-RDTs, use of facial masks, and adequate air ventilation. The event took place in the Sala Apolo, Barcelona, Spain. Adults aged 18-59 years with a negative result in an Ag-RDT from a nasopharyngeal swab collected immediately before entering the event were randomised 1:1 (block randomisation stratified by age and gender) to either attend the indoor event for 5 hours or go home. Nasopharyngeal specimens used for Ag-RDT screening were analysed by real-time reverse-transcriptase PCR (RT-PCR) and cell culture (Vero E6 cells). 8 days after the event, a nasopharyngeal swab was collected and analysed by Ag-RDT, RT-PCR, and a transcription-mediated amplification test (TMA). The primary outcome was the difference in incidence of RT-PCR-confirmed SARS-CoV-2 infection at 8 days between the control and the intervention groups, assessed in all participants who were randomly assigned, attended the event, and had a valid result for the SARS-CoV-2 test done at follow-up. The trial is registered at ClinicalTrials.gov, NCT04668625.FindingsParticipant enrollment took place during the morning of the day of the concert, Dec 12, 2020. Of the 1140 people who responded to the call and were deemed eligible, 1047 were randomly assigned to either enter the music event (experimental group) or continue with normal life (control group). Of the 523 randomly assigned to the experimental group, 465 were included in the analysis of the primary outcome (51 did not enter the event and eight did not take part in the follow-up assessment), and of the 524 randomly assigned to the control group, 495 were included in the final analysis (29 did not take part in the follow-up). At baseline, 15 (3%) of 495 individuals in the control group and 13 (3%) of 465 in the experimental group tested positive on TMA despite a negative Ag-RDT result. The RT-PCR test was positive in one case in each group and cell viral culture was negative in all cases. 8 days after the event, two (<1%) individuals in the control arm had a positive Ag-RDT and PCR result, whereas no Ag-RDT nor RT-PCR positive results were found in the intervention arm. The Bayesian estimate for the incidence between the experimental and control groups was -0·15% (95% CI -0·72 to 0·44).InterpretationOur study provides preliminary evidence on the safety of indoor mass-gathering events during a COVID-19 outbreak under a comprehensive preventive intervention. The data could help restart cultural activities halted during COVID-19, which might have important sociocultural and economic implications.FundingPrimavera Sound Group and the #YoMeCorono Initiative.TranslationFor the Spanish translation of the abstract see Supplementary Materials section.

Dataset Information

SARS-CoV-2 transmission risk screening for safer social events: a non-randomised controlled study.

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SARS-CoV-2 transmission risk screening for safer social events: a non-randomised controlled study.

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