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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Swab Site and Sample Collector on Testing Sensitivity for COVID-19 Virus in Symptomatic Individuals

NCT04321369

Infections, Respiratory Fever Cough

COMPLETED

NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons

NCT04799392

COVID-19 SARS-CoV-2 Coronavirus

TERMINATED NA

Sensitivity and Specificity of SARS-CoV-2 Rapid Antigen Test Compared to RT-PCR Test

NCT04689399

Covid19 Rapid Antigen Test SARS-CoV-2

COMPLETED NA

A Longitudinal Study of COVID-19 Positive Patients Testing Nasal Swabs and Collecting Blood Samples for Research

NCT04327804

SARS-CoV Infection

COMPLETED

Sensitivity of Frequent SARS-CoV-2 (COVID-19) Rapid Antigen Testing Regimen

NCT04805840

Covid19

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Individually randomised trial.

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rapid test and concert

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

Group Type EXPERIMENTAL

SARS-CoV-2 antigen rapid test

Intervention Type DIAGNOSTIC_TEST

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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SARS-CoV-2 antigen rapid test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)