Clinical trial NCT04898127: Antigen Rapid Test Screening to Prevent SARS-CoV-2 Transmission (COVID-19) at Mass Gathering Events.
Official title: Antigen Rapid Test Screening to Prevent SARS-CoV-2 Transmission at Mass Gathering Events. A Randomised Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Covid19
Keywords: COVID-19
Infection control
Rapid test
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: University of Oslo
First posted: 2021-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individually randomised trial.
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Aged 18-45 years
* Willingness to be randomised and to have a PCR-test taken a week after mass gathering event (both intervention and control groups)

Exclusion Criteria:

* Vaccinated for COVID-19
* Having tested positive for SARS-CoV-2 the last 6 months
* Risk factors for severe COVID-19

Primary outcomes:
measure: SARS-CoV-2 infection
timeFrame: 6-8 days after mass gathering event
Secondary outcomes:
measure: Clinical COVID-19 disease
timeFrame: 1 to 14 days after mass gathering event
measure: Hospital admissions
timeFrame: 1 to 3 weeks after mass gathering event
measure: False positive rapid test
timeFrame: Within 24 hours.
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian Institute of Public Health
name: Atle Fretheim, PhD
role: PRINCIPAL_INVESTIGATOR
References: