NCT05045846

Brief Summary

The aim of this study was to determine the accuracy of anterior nasal swab in rapid antigen (Ag)-tests in a low SARS-CoV-2 prevalence and massive screened community.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,461

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

29 days

First QC Date

September 14, 2021

Last Update Submit

September 14, 2021

Conditions

Covid19

Keywords

rapid antigen test

Outcome Measures

Primary Outcomes (1)

  • Accuracy of anterior nasal swab in rapid antigen (Ag)-tests

    1 month

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The infection pressure in the Capital Region of Denmark including Testcenter Taastrup was below 1.0%, throughout the study period

You may qualify if:

  • Citizens, above 18 years of age, who had self-booked an appointment for COVID-19 test at Testcenter Taastrup, Copenhagen, Denmark, in the period of 2nd of March to 22nd of March were offered to participate in the project

You may not qualify if:

  • Patients referred to COVID-19 testing by a doctor with symptoms of COVID-19 were tested in a separate section of the test centers and are not included in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christian von Buchwald, MD, DMSc, Professor

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor, investigator

Study Record Dates

First Submitted

September 14, 2021

First Posted

September 16, 2021

Study Start

March 1, 2021

Primary Completion

March 30, 2021

Study Completion

March 30, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

DK(1)