Antigen Rapid Test Screening to Prevent SARS-CoV-2 Transmission (COVID-19) at Mass Gathering Events.
Primary Purpose
Covid19
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SARS-CoV-2 antigen rapid test
Sponsored by
About this trial
This is an interventional screening trial for Covid19 focused on measuring COVID-19, Infection control, Rapid test
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rapid test and concert
Control
Arm Description
Participants in this arm will be offered access to a concert, after a negative rapid test.
Participants in this are will not be offered access to a concert during the study period.
Outcomes
Primary Outcome Measures
SARS-CoV-2 infection
Positive PCR-test
Secondary Outcome Measures
Clinical COVID-19 disease
Registered diagnosis in administrative databases
Hospital admissions
Registered in administrative database
False positive rapid test
Rapid tests that yield a positive result which is not confirmed by PCR test
Full Information
NCT ID
NCT04898127
First Posted
May 21, 2021
Last Updated
March 23, 2023
Sponsor
Norwegian Institute of Public Health
Collaborators
University of Oslo
1. Study Identification
Unique Protocol Identification Number
NCT04898127
Brief Title
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The study needed approval from local authorities (City of Oslo and City of Bergen) to take place, which it did not get.
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian Institute of Public Health
Collaborators
University of Oslo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, Infection control, Rapid test
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individually randomised trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapid test and concert
Arm Type
Experimental
Arm Description
Participants in this arm will be offered access to a concert, after a negative rapid test.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this are will not be offered access to a concert during the study period.
Intervention Type
Diagnostic Test
Intervention Name(s)
SARS-CoV-2 antigen rapid test
Intervention Description
Rapid test before access to mass gathering event (concert), provided the test result is negative.
Primary Outcome Measure Information:
Title
SARS-CoV-2 infection
Description
Positive PCR-test
Time Frame
6-8 days after mass gathering event
Secondary Outcome Measure Information:
Title
Clinical COVID-19 disease
Description
Registered diagnosis in administrative databases
Time Frame
1 to 14 days after mass gathering event
Title
Hospital admissions
Description
Registered in administrative database
Time Frame
1 to 3 weeks after mass gathering event
Title
False positive rapid test
Description
Rapid tests that yield a positive result which is not confirmed by PCR test
Time Frame
Within 24 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atle Fretheim, PhD
Organizational Affiliation
Norwegian Institute of Public Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Antigen Rapid Test Screening to Prevent SARS-CoV-2 Transmission (COVID-19) at Mass Gathering Events.
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