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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01264-37 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| PRODISS | UNKNOWN |
| WEEZEVENT | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The objective is to demonstrate if there is no increase in the risk of Sars-Cov-2 salivary carriage 7 days after a concert in the group participating in the event compared to a non participating group who stayed at home.
The hypothesis is that a systematic screening of Sars-Cov-2 within the 3 days before the event allows to control the risk of transmission and prevent cluster of transmission during the concert.
Before inclusion, the participants will be able to pre-register to the event via a website. They will get an appointment for an inclusion visit at the Accor Arena (Paris Bercy, France).
During 3 days (from D-3 to D-1), participants with a registration will come to the Accor Arena to have a rapid Sars-Cov-2 antigen test (results in 15 min).
If the test is positive, the participant will be contacted and managed by the medical team in charge of the national strategy for positives cases.
People with a negative test will be included and randomized :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | People at the concert |
|
| Control | Active Comparator | People staying at home |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concert | Other | People attending a concert in a closed area, with a mask |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with a positive salivary RT-PCR at day 7 after the date of the concert | Prove the lack of increase of salivary carriage risk of SARS-CoV-2 on day 7 in participants present at the concert (experimental group) compared to non-participants at the event (control group) | 7 days after the concert (-1/+8 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants in each group with a positive salivary RT-PCR the day of the concert | Evaluation of the salivary carriage on day 0 (the concert day) despite a negative test within 3 days before the event and the conversion rate of salivary carriage between D0 and D7 | The day of the concert |
| Molecular analysis of transmission clusters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Constance DELAUGERRE, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AccorHotels Arena | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34843662 | Result | Delaugerre C, Foissac F, Abdoul H, Masson G, Choupeaux L, Dufour E, Gastli N, Delarue SM, Nere ML, Minier M, Gabassi A, Salmona M, Seguineau M, Schmitt S, Tonglet S, Olivier A, Poyart C, Le Goff J, Lescure X, Kerneis S, Treluyer JM; SPRING study group. Prevention of SARS-CoV-2 transmission during a large, live, indoor gathering (SPRING): a non-inferiority, randomised, controlled trial. Lancet Infect Dis. 2022 Mar;22(3):341-348. doi: 10.1016/S1473-3099(21)00673-3. Epub 2021 Nov 26. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Rapid nasopharyngeal antigen test for Sars-Cov-2 |
| Diagnostic Test |
A nasopharyngeal swab at inclusion (up to 3 days before concert) to confirm eligibility |
|
| Saliva Sample | Diagnostic Test | Saliva samples sent by participant at Day0 and Day7 |
|
Comparison of the sequence of complete viral genome in participant with a positive test at day 7 |
| 7 days after the concert (-1/+8 days) |
| Average percentage of participants wearing their mask adequately for the duration of event | Estimate the overall compliance of the mask wearing by the participants during the duration of the event (covering nose and mouth) | The day of the concert |
| Percentage of adequate mask wearing among participants according to location and time | Identify the circumstances (place, time) of failure of accurate mask wearing by the participants | The day of the concert |
| Percentage of participants who downloaded and / or used the TousAntiCovid application at the time of inclusion | Estimate the feasibility and acceptability of using the Tousanticovid application | The day of the concert |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |