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

March 24, 2023 updated by: Tobias Todsen, Rigshospitalet, Denmark
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • Valby COVID19 testcenter
        • Contact:
          • Tobias Gredal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

The inclusion criterion:

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

The exclusion criteria are :

A. Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs.

B. Do not understand oral or written Danish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence for upper airway specimen collection (NPS right - Nasal swab left - OPS)

1 NPS right - Nasal swab left - OPS

NPS = nasopharyngeal swab OPS = oropharyngeal swab
Diagnostic test: (NPS right - Nasal swab left - OPS)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Experimental: Sequence for upper airway specimen collection (NPS left - Nasal swab right - OPS)
2 NPS left - Nasal swab right - OPS
Diagnostic test: (NPS left - Nasal swab right - OPS)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Experimental: Sequence for upper airway specimen collection (Nasal swab right - NPS left - OPS)
3 Nasal swab right - NPS left - OPS
Diagnostic test: (Nasal swab right - NPS left - OPS)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Experimental: Sequence for upper airway specimen collection (Nasal swab left - NPS right - OPS)
4 Nasal swab left - NPS right - OPS
Diagnostic test: (Nasal swab left - NPS right - OPS)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Experimental: Sequence for upper airway specimen collection (NPS right - OPS - Nasal swab left)
5 NPS right - OPS - Nasal swab left
Diagnostic test: (NPS right - OPS - Nasal swab left)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Experimental: Sequence for upper airway specimen collection (NPS left - OPS - Nasal swab right)
6 NPS left - OPS - Nasal swab right
Diagnostic test: (NPS left - OPS - Nasal swab right)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Experimental: Sequence for upper airway specimen collection (Nasal swab right - OPS - NPS left)
7 Nasal swab right - OPS - NPS left
Diagnostic test: (Nasal swab right - OPS - NPS left)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Experimental: Sequence for upper airway specimen collection (Nasal swab left - OPS - NPS right)
8 Nasal swab left - OPS - NPS right
Diagnostic test: (Nasal swab left - OPS - NPS right)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Experimental: Sequence for upper airway specimen collection (OPS - NPS right - Nasal swab left)
9 OPS - NPS right - Nasal swab left
Diagnostic test: (OPS - NPS right - Nasal swab left)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Experimental: Sequence for upper airway specimen collection (OPS - NPS left - Nasal swab right)
10 OPS - NPS left - Nasal swab right
Diagnostic test: (OPS - NPS left - Nasal swab right)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Experimental: Sequence for upper airway specimen collection (OPS - Nasal swab left - NPS right)
11 OPS - Nasal swab left - NPS right
Diagnostic test: (OPS - Nasal swab left - NPS right)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
Experimental: Sequence for upper airway specimen collection (OPS - Nasal swab right - NPS left)
12 OPS - Nasal swab right - NPS left
Diagnostic test: (OPS - Nasal swab right - NPS left)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RT-PCR for upper airway viral diagnostics
Time Frame: 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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local immunological mediators from the upper airway tract
Time Frame: 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).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2023

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-23006949

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on (NPS right - Nasal swab left - OPS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe