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

NCT04898127 | Withdrawn

• 1 other identifier: CristinID2510078
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19

Keywords

COVID-19; Infection control; Rapid test

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 infection

  Positive PCR-test

  6-8 days after mass gathering event

Secondary Outcomes (3)

• Clinical COVID-19 disease

  1 to 14 days after mass gathering event

• Hospital admissions

  1 to 3 weeks after mass gathering event

• False positive rapid test

  Within 24 hours.

Study Arms (2)

Rapid test and concert

EXPERIMENTAL

Participants in this arm will be offered access to a concert, after a negative rapid test.

Diagnostic Test: SARS-CoV-2 antigen rapid test

Control

NO INTERVENTION

Participants in this are will not be offered access to a concert during the study period.

Interventions

SARS-CoV-2 antigen rapid test DIAGNOSTIC_TEST

Rapid test before access to mass gathering event (concert), provided the test result is negative.

Rapid test and concert

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Norwegian Institute of Public Health: lead
• University of Oslo: collaborator

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Atle Fretheim, PhD

  Norwegian Institute of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Individually randomised trial.

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 24, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 27, 2023

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Until 31. July 2026.