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The study needed approval from local authorities (City of Oslo and City of Bergen) to take place, which it did not get.
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| Name | Class |
|---|---|
| University of Oslo | OTHER |
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To investigate the impact of rapid antigen testing for Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2), the investigators plan to conduct a large trial to assess the impact of using rapid tests to screen people before participating at a mass gathering event, i.e. a music concert. Among participants who wish to attend and fulfill the inclusion criteria, half will be offered access to rapid testing and concert (provided the test is negative), and the other half will not. Allocation will be by randomisation. A week after the concert both groups will be tested by means of a standard PCR-test.
To investigate the impact of rapid SARS-CoV-2 antigen testing on the incidence of COVID-19, the investigators plan to conduct a large trial to assess the impact of using rapid tests to screen people before participating a mass gathering event, i.e. a music concert. The hypothesis is that screening by means of rapid testing eliminates any increase in risk of COVID-19 from attending a mass gathering event.
The investigators will recruit Individuals aged 18-45 years, who wish to attend a specific concert, have not received vaccination or had Covid-19 in the past six months, and are not in any risk group for severe disease. At recruitment, all participants (both concert and no-concert groups) will sign a consent form where they commit to using a contact tracing app, and to allowing the research group to use their data in the Norwegian Emergency Preparedness Register (BEREDT C19). They will also consent to having a COVID-19-test (PCR) conducted 6-8 days after the concert date.
After placing their payment, they will be randomised to be given access to a music concert (concert group), or not (no-concert group). Those who are randomised to the concert group will be tested for SARS-CoV-2 using a rapid antigen test, shortly before the concert. Those who test positive will be excluded from attending the concert and will immediately be offered a PCR-test.
All participants will be instructed to stay at home if they have symptoms of COVID-19 or are in quarantine. Participants who have symptoms or are quarantined at the time of the follow-up test will be offered a test through home visit by a mobile clinic.
Infection control measures will be applied to all concert participants in line with standards established by the sector, e.g. hand hygiene measures and a logistical system that seeks to minimise the risk of transmission during entry to the arena and exit after the concert
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid test and concert | Experimental | Participants in this arm will be offered access to a concert, after a negative rapid test. |
|
| Control | No Intervention | Participants in this are will not be offered access to a concert during the study period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 antigen rapid test | Diagnostic Test | Rapid test before access to mass gathering event (concert), provided the test result is negative. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SARS-CoV-2 infection | Positive PCR-test | 6-8 days after mass gathering event |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical COVID-19 disease | Registered diagnosis in administrative databases | 1 to 14 days after mass gathering event |
| Hospital admissions | Registered in administrative database |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atle Fretheim, PhD | Norwegian Institute of Public Health | Principal Investigator |
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We will collect very limited IPD: Beyond outcome measures, the IPD will be age, sex. These data can be shared, at the individual level.
Until 31. July 2026.
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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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Individually randomised trial.
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| 1 to 3 weeks after mass gathering event |
| False positive rapid test | Rapid tests that yield a positive result which is not confirmed by PCR test | Within 24 hours. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |