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InfluenzaNCT05765838

Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens.

A study testing (NPS right - Nasal swab left - OPS), (NPS left - Nasal swab right - OPS) and (Nasal swab right - NPS left - OPS) in people with Influenza and COVID-19, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a comparative prospective diagnostic accuracy study reported according to the STARD guidelines. Citizens at an outpatient COVID19 test facility at Testcenter Danmark Valby will be invited to participate in the study on a volunteer basis. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza, COVID-19, RSV Infection
What is being tested?
(NPS right - Nasal swab left - OPS), (NPS left - Nasal swab right - OPS) and (Nasal swab right - NPS left - OPS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
1 siteDenmark
Study dates
3 Mar 2023to 1 Jul 2023
Phase
Interventional
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
  • Healthy volunteers accepted
  • Adult, Older adult

The inclusion criterion:

  1. 18 years or more of age requiring a test for COVID-19.

The exclusion criteria are :

  1. Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs.
  2. Do not understand oral or written Danish

Trial locations and contacts

1 site in 1 country.

Tobias Todsen, MD contact

+35453545

tobias.todsen@regionh.dk

Denmark1 site, 1 recruiting

  • Valby COVID19 testcenter

    Copenhagen

    Tobias Gredal

    Recruiting

Other trials in Denmark

About this study

This is a comparative prospective diagnostic accuracy study reported according to the STARD guidelines. Citizens at an outpatient COVID19 test facility at Testcenter Danmark Valby will be invited to participate in the study on a volunteer basis. The enrolled participants will have the planned oropharyngeal swab performed in the test center and sent for a SARS-CoV-2 RT-PCR test at TestCenter Danmark, Statens Serum Institut, Copenhagen, Denmark as usual. Besides the planned oropharyngeal swab performed in the test center, the participants will have additional specimens collected in form of saliva, nasopharyngeal-, nasal-, and oropharyngeal swabs. These will all be used for the detection of nucleic acids from the four most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2), SARS-CoV-2 and RSV A/B. Further we will measure immune mediating cytokines, chemokines, and interleukins in the different specimens. These analyses will be performed at Technical University of Denmark (DTU).

Being tested
(NPS right - Nasal swab left - OPS), (NPS left - Nasal swab right - OPS), (Nasal swab right - NPS left - OPS), (Nasal swab left - NPS right - OPS), (NPS right - OPS - Nasal swab left)
Medical subject headings
Influenza, Human, COVID-19, Respiratory Syncytial Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • (NPS right - Nasal swab left - OPS)Diagnostic test

    Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

  • (NPS left - Nasal swab right - OPS)Diagnostic test

    Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

  • (Nasal swab right - NPS left - OPS)Diagnostic test

    Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

  • (Nasal swab left - NPS right - OPS)Diagnostic test

    Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

  • (NPS right - OPS - Nasal swab left)Diagnostic test

    Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

  • (NPS left - OPS - Nasal swab right)Diagnostic test

    Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

  • (Nasal swab right - OPS - NPS left)Diagnostic test

    Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

  • (Nasal swab left - OPS - NPS right)Diagnostic test

    Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

  • (OPS - NPS right - Nasal swab left)Diagnostic test

    Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

  • (OPS - NPS left - Nasal swab right)Diagnostic test

    Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

  • (OPS - Nasal swab left - NPS right)Diagnostic test

    Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

  • (OPS - Nasal swab right - NPS left)Diagnostic test

    Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

Study groups in NCT05765838
Study groupRoleWhat they receive
Sequence for upper airway specimen collection (NPS right - Nasal swab left - OPS)Experimental1 NPS right - Nasal swab left - OPS NPS = nasopharyngeal swab OPS = oropharyngeal swab
Receives: Diagnostic Test: (NPS right - Nasal swab left - OPS)
Sequence for upper airway specimen collection (NPS left - Nasal swab right - OPS)Experimental2 NPS left - Nasal swab right - OPS
Receives: Diagnostic Test: (NPS left - Nasal swab right - OPS)
Sequence for upper airway specimen collection (Nasal swab right - NPS left - OPS)Experimental3 Nasal swab right - NPS left - OPS
Receives: Diagnostic Test: (Nasal swab right - NPS left - OPS)
Sequence for upper airway specimen collection (Nasal swab left - NPS right - OPS)Experimental4 Nasal swab left - NPS right - OPS
Receives: Diagnostic Test: (Nasal swab left - NPS right - OPS)
Sequence for upper airway specimen collection (NPS right - OPS - Nasal swab left)Experimental5 NPS right - OPS - Nasal swab left
Receives: Diagnostic Test: (NPS right - OPS - Nasal swab left)
Sequence for upper airway specimen collection (NPS left - OPS - Nasal swab right)Experimental6 NPS left - OPS - Nasal swab right
Receives: Diagnostic Test: (NPS left - OPS - Nasal swab right)
Sequence for upper airway specimen collection (Nasal swab right - OPS - NPS left)Experimental7 Nasal swab right - OPS - NPS left
Receives: Diagnostic Test: (Nasal swab right - OPS - NPS left)
Sequence for upper airway specimen collection (Nasal swab left - OPS - NPS right)Experimental8 Nasal swab left - OPS - NPS right
Receives: Diagnostic Test: (Nasal swab left - OPS - NPS right)
Sequence for upper airway specimen collection (OPS - NPS right - Nasal swab left)Experimental9 OPS - NPS right - Nasal swab left
Receives: Diagnostic Test: (OPS - NPS right - Nasal swab left)
Sequence for upper airway specimen collection (OPS - NPS left - Nasal swab right)Experimental10 OPS - NPS left - Nasal swab right
Receives: Diagnostic Test: (OPS - NPS left - Nasal swab right)
Sequence for upper airway specimen collection (OPS - Nasal swab left - NPS right)Experimental11 OPS - Nasal swab left - NPS right
Receives: Diagnostic Test: (OPS - Nasal swab left - NPS right)
Sequence for upper airway specimen collection (OPS - Nasal swab right - NPS left)Experimental12 OPS - Nasal swab right - NPS left
Receives: Diagnostic Test: (OPS - Nasal swab right - NPS left)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RT-PCR for upper airway viral diagnostics

    the detection of nucleic acids from the four most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2), SARS-CoV-2 and RSV A/B

    Measured: 1 day

Secondary outcomes (1)

  1. local immunological mediators from the upper airway tract

    measure interferon γ (IFN-γ), C-X-C motif chemokine 10 (CXCL10/IP10), interleukin 10 (IL-10), interleukin 12p70, interleukin 13 (IL-13), interleukin 1β (IL-1β), interleukin 2, interleukin 4 (IL-4), interleukin 5 (IL-5), interleukin 6, CXCL8, tumor necrosis factor α (TNF-α), C-C motif chemokine 5 (CCL5/RANTES), interferon α2a, and granulocyte macrophage colony-stimulating factor (GM-CSF).

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2023
  2. Study start3 Mar 2023
  3. Primary completion1 Apr 2023 (estimated)
  4. Study completion1 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Sequential
Model description
The order of the swabs performed will be decided with randomization to either of the eight combination: 1. NPS right - Nasal swab left - OPS 2. NPS left - Nasal swab right - OPS 3. Nasal swab right - NPS left - OPS 4. Nasal swab left - NPS right - OPS 5. NPS right - OPS - Nasal swab left 6. NPS left - OPS - Nasal swab right 7. Nasal swab right - OPS - NPS left 8. Nasal swab left - OPS - NPS right 9. OPS - NPS right - Nasal swab left 10. OPS - NPS left - Nasal swab right 11. OPS - Nasal swab left - NPS right 12. OPS - Nasal swab right - NPS left
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05765838
Sponsor's protocol ID
H-23006949
Status last verified
Mar 2023
First submitted
1 Mar 2023
Last updated
28 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Lopez-Perez M, Benfield T, Jakobsen KK, Dal MH, Stange SD, Ersboll AK, Larsen H, Berger SS, Gredal T, Buchwald Cv, Kirkby N, Todsen T. Diagnostic performance of upper airway sampling sites for SARS-CoV-2 and influenza testing. Microbiol Spectr. 2026 Jan 6;14(1):e0221225. doi: 10.1128/spectrum.02212-25. Epub 2025 Nov 17.

    PubMed 41247054

Questions about this trial

What is this clinical trial studying?

A study testing (NPS right - Nasal swab left - OPS), (NPS left - Nasal swab right - OPS) and (Nasal swab right - NPS left - OPS) in people with Influenza and COVID-19, run by Copenhagen University Hospital, Rigshospitalet 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?

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: status not confirmed, as of the sponsor's last update on 28 Mar 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tobias Todsen, MD (+35453545, tobias.todsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RT-PCR for upper airway viral diagnostics (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05765838, which also lists 1 linked publication.

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 28 Mar 2023.

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