Antigen Rapid Test Screening to Prevent SARS-CoV-2 Transmission (COVID-19) at Mass Gathering Events.

Covid19 Clinical Trial

Official title:

Antigen Rapid Test Screening to Prevent SARS-CoV-2 Transmission at Mass Gathering Events. A Randomised Trial.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04898127
• Other study ID #: CristinID2510078
• Status: Withdrawn
• Phase: N/A
• Start date: May 2021
• Est. completion date: December 2021

Study information

• Verified date: May 2021
• Source: Norwegian Institute of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• SARS-CoV-2 antigen rapid test
Rapid test before access to mass gathering event (concert), provided the test result is negative.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian Institute of Public Health	University of Oslo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 infection	Positive PCR-test	6-8 days after mass gathering event
Secondary	Clinical COVID-19 disease	Registered diagnosis in administrative databases	1 to 14 days after mass gathering event
Secondary	Hospital admissions	Registered in administrative database	1 to 3 weeks after mass gathering event
Secondary	False positive rapid test	Rapid tests that yield a positive result which is not confirmed by PCR test	Within 24 hours.