NCT05611203

Brief Summary

Citizens who undergo testing for COVID-19 at one of two Testcenters in Copenhagen Captial Region will be invited to participate in the study. The participants will be randomized to either an oropharyngeal swap including the palatine tonsils OR an oropharyngeal swap without the palatine tonsils for SARS-CoV-2 testing. The swabs will be sent to the clinical microbiology laboratory for SARS-CoV-2 detection using RT-PCR. The diagnostic accuracy and SARS-CoV-2 viral load will be compared. The participants will be asked to complete a questionnaire regarding their symptoms.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

November 3, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

November 10, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

November 3, 2022

Last Update Submit

January 10, 2023

Conditions

SARS-CoV InfectionCoronavirusCorona Virus Infection

Outcome Measures

Primary Outcomes (1)

  • RT-PCR results

    The detection rate of SARS-CoV-2 RNA

    Day 1

Secondary Outcomes (6)

  • Sycle threshold (Ct)

    Day 1

  • Inconclusive tests

    Day 1

  • Test discomfort

    Day 1

  • Development of COVID-19 disease after testing

    1 month

  • Test accuracy between healthcare workers

    Day 1

  • +1 more secondary outcomes

Study Arms (2)

Oropharyngeal swab only including the posterior oropharyngeal wall

EXPERIMENTAL

An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall only

Procedure: An Oropharyngeal swab

Oropharyngeal swab including the posterior oropharyngeal wall and both palatine tonsils

EXPERIMENTAL

An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall and both palatine tonsils

Procedure: An Oropharyngeal swab

Interventions

An Oropharyngeal swabPROCEDURE

An Oropharyngeal swab performed for diagnostic purposes

Oropharyngeal swab including the posterior oropharyngeal wall and both palatine tonsilsOropharyngeal swab only including the posterior oropharyngeal wall

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • citizens referred for outpatient testing for COVID-19 in Valby and Hillerød COVID-19 TestCenter.

You may not qualify if:

  • Age under 18 years
  • neck breathers (tracheostomy/laryngectomy patients)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hillerød Covid-19 Testcenter

Copenhagen, Hillerød, 3400, Denmark

RECRUITING

Valby

Copenhagen, 2500, Denmark

RECRUITING

Related Publications (1)

  • Hartvigsen B, Jakobsen KK, Benfield T, Gredal NT, Ersboll AK, Gronlund MW, Bundgaard H, Andersen MP, Steenhard N, von Buchwald C, Todsen T. Molecular Detection of SARS-CoV-2 From Throat Swabs Performed With or Without Specimen Collection From the Tonsils: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 12;13:e47446. doi: 10.2196/47446.

    PMID: 38865190DERIVED

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCoronavirus Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Central Study Contacts

Tobias Todsen, MD, PhD

CONTACT

+45 35466008tobias.todsen@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Associate Prof

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 9, 2022

Study Start

November 10, 2022

Primary Completion

January 30, 2023

Study Completion

March 2, 2023

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

DK(2)