Covid19NCT05045846
Diagnostic Accuracy of Rapid Antigen Test Based on Anterior Nasal Swab Compared With RT-PCR for SARS-CoV-2 Detection.
An observational study of Covid19, run by Christian von Buchwald at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 3,461 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 30 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The infection pressure in the Capital Region of Denmark including Testcenter Taastrup was below 1.0%, throughout the study period
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Covid19
- Keywords
- rapid antigen test
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of anterior nasal swab in rapid antigen (Ag)-tests
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Mar 2021
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 3,461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian von Buchwald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian von Buchwald, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045846
- Sponsor's protocol ID
- COVID-19 rapid antigen test
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Rapid Antigen Test Based on Anterior Nasal Swab Compared With RT-PCR for SARS-CoV-2 Detection.
- ClinicalTrials.gov ID
- NCT05045846
- Acronym / sponsor ID
- COVID-19 rapid antigen test
- Conditions
- Covid19
- Keywords
- rapid antigen test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,461 participants (actual)
- Lead sponsor
- Christian von BuchwaldUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The infection pressure in the Capital Region of Denmark including Testcenter Taastrup was below 1.0%, throughout the study period
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of anterior nasal swab in rapid antigen (Ag)-tests
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Christian von Buchwald at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of anterior nasal swab in rapid antigen (Ag)-tests (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.