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

Not Applicable

Recruiting

• Conditions: RSV Infection; COVID-19; Influenza
• Interventions: Diagnostic Test: (OPS - Nasal swab left - NPS right); Diagnostic Test: (NPS left - Nasal swab right - OPS); Diagnostic Test: (Nasal swab left - NPS right - OPS); Diagnostic Test: (NPS right - OPS - Nasal swab left); Diagnostic Test: (Nasal swab left - OPS - NPS right); Diagnostic Test: (OPS - NPS left - Nasal swab right); Diagnostic Test: (NPS right - Nasal swab left - OPS); Diagnostic Test: (OPS - Nasal swab right - NPS left); Diagnostic Test: (Nasal swab right - NPS left - OPS); Diagnostic Test: (NPS left - OPS - Nasal swab right); Diagnostic Test: (Nasal swab right - OPS - NPS left); Diagnostic Test: (OPS - NPS right - Nasal swab left)

• Registration Number: NCT05765838
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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. 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Study Start: 2023-03-03
• Study First Posted: 2023-03-13
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-28
• Primary Completion: 2023-04-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Sequence for upper airway specimen collection (OPS - Nasal swab left - NPS right)	(OPS - Nasal swab left - NPS right)	11 OPS - Nasal swab left - NPS right
Sequence for upper airway specimen collection (NPS left - Nasal swab right - OPS)	(NPS left - Nasal swab right - OPS)	2 NPS left - Nasal swab right - OPS
Sequence for upper airway specimen collection (Nasal swab left - NPS right - OPS)	(Nasal swab left - NPS right - OPS)	4 Nasal swab left - NPS right - OPS
Sequence for upper airway specimen collection (NPS right - OPS - Nasal swab left)	(NPS right - OPS - Nasal swab left)	5 NPS right - OPS - Nasal swab left
Sequence for upper airway specimen collection (Nasal swab left - OPS - NPS right)	(Nasal swab left - OPS - NPS right)	8 Nasal swab left - OPS - NPS right
Sequence for upper airway specimen collection (OPS - NPS left - Nasal swab right)	(OPS - NPS left - Nasal swab right)	10 OPS - NPS left - Nasal swab right
Sequence for upper airway specimen collection (NPS right - Nasal swab left - OPS)	(NPS right - Nasal swab left - OPS)	1 NPS right - Nasal swab left - OPS NPS = nasopharyngeal swab OPS = oropharyngeal swab
Sequence for upper airway specimen collection (OPS - Nasal swab right - NPS left)	(OPS - Nasal swab right - NPS left)	12 OPS - Nasal swab right - NPS left
Sequence for upper airway specimen collection (Nasal swab right - NPS left - OPS)	(Nasal swab right - NPS left - OPS)	3 Nasal swab right - NPS left - OPS
Sequence for upper airway specimen collection (NPS left - OPS - Nasal swab right)	(NPS left - OPS - Nasal swab right)	6 NPS left - OPS - Nasal swab right
Sequence for upper airway specimen collection (Nasal swab right - OPS - NPS left)	(Nasal swab right - OPS - NPS left)	7 Nasal swab right - OPS - NPS left
Sequence for upper airway specimen collection (OPS - NPS right - Nasal swab left)	(OPS - NPS right - Nasal swab left)	9 OPS - NPS right - Nasal swab left

Primary Outcome Measures

Name	Time	Method
RT-PCR for upper airway viral diagnostics	1 day	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

Secondary Outcome Measures

Name	Time	Method
local immunological mediators from the upper airway tract	1 day	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).

Trial Locations

Locations (1)

Valby COVID19 testcenter; 🇩🇰 Copenhagen, Denmark