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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: SARS-CoV-2 antigen rapid 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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Atle Fretheim, PhD; Phone Number: +4791649828; Email: atle.fretheim@fhi.no
• Study Contact Backup: Name: Arnfinn Helleve, PhD; Phone Number: +4793046659; Email: arnfinn.helleve@fhi.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rapid test and concert; Participants in this arm will be offered access to a concert, after a negative rapid test.	Diagnostic test: SARS-CoV-2 antigen rapid test; Rapid test before access to mass gathering event (concert), provided the test result is negative.
No Intervention: Control; Participants in this are will not be offered access to a concert during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SARS-CoV-2 infection	Positive PCR-test	6-8 days after mass gathering event

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Norwegian Institute of Public Health
• Collaborators: University of Oslo
• Investigators: Principal Investigator: Atle Fretheim, PhD, Norwegian Institute of Public Health

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; Infection control; Rapid test
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CristinID2510078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will collect very limited IPD: Beyond outcome measures, the IPD will be age, sex. These data can be shared, at the individual level.
• IPD Sharing Time Frame: Until 31. July 2026.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No