NCT05043623

Brief Summary

A study to investigate Rhinoswab as an alternative method to combined throat and deep nasal (CTDN) swab for respiratory sample collection in children who present to the Royal Children's Hospital (RCH) for viral testing. Children and their parent/guardian will answer a short survey about their preferences. Laboratory staff will answer a short survey about handling the different samples.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
339

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

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

August 26, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 26, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

August 26, 2021

Last Update Submit

February 6, 2023

Conditions

SARS CoV 2 InfectionCOVID-19

Keywords

Rhinoswab Junior

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)

    The results (detected/not detected) on all 13 viruses on the standard respiratory panel from both the Rhinoswab and the standard swabs will be obtained, and the sensitivity of the Rhinoswab compared to the CTDN determined. Sensitivity is calculated only in the participants who tested positive for the respective virus using the CTDN swab and is calculated as the proportion patients who tested positive on the Rhinoswab among those who tested positive on the CTDN swab. 95% confidence intervals will be calculated.

    5 minutes from administering test

  • Specificity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)

    The results (detected/not detected) on all 13 viruses on the standard respiratory panel from both the Rhinoswab and the standard swabs will be obtained, and the specificity of the Rhinoswab compared to the CTDN determined. Specificity is calculated only in participants who tested negative for respiratory viruses and is calculated as the proportion patients who tested negative on Rhinoswab among those who tested negative on CTDN swab. 95% confidence intervals will be calculated.

    5 minutes from administering test

Secondary Outcomes (9)

  • Ct-Value of respiratory viruses on Rhinoswab compared with Ct-value of respiratory viruses on CTDN (Clinician-Collected/Supervised)

    5 minutes from administering test

  • Swab Preference Assessment (Clinician-Collected/Supervised )

    5 minutes from administering test

  • Median Ct-value of SARS-CoV-2 on Rhinoswab vs saliva vs CTDN (Self-collected)

    5 minutes from administering test

  • Sensitivity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)

    5 minutes from administering test

  • Specificity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)

    5 minutes from administering test

  • +4 more secondary outcomes

Study Arms (4)

Arm 1 - Clinician Collected/supervised Rhinoswab first, then CTDN swab

EXPERIMENTAL

Rhinoswab test administered and immediately followed by CTDN. Rhinoswab swab tested on respiratory panel vs CTDN swab tested on respiratory panel (standard of care).

Device: Rhinoswab JuniorDevice: Combined nose and throat swab

Arm 2 - Clinician Collected/supervised CTDN swab first, then Rhinoswab

EXPERIMENTAL

CTDN test administered and immediately followed by Rhinoswab. CTDN swab tested on respiratory panel (standard of care) vs Rhinoswab swab tested on respiratory panel.

Device: Rhinoswab JuniorDevice: Combined nose and throat swab

Arm 3 - Self-collected Rhinoswab, saliva swab, CTDN

EXPERIMENTAL

In children 5-18 years, the child/parent/guardian collects the three samples, in order of patient/parent preference. All samples will be tested on the SARS-CoV-2 laboratory panel (Allplex™ SARS-CoV-2 Assay - Seegene Inc)

Device: Rhinoswab JuniorDevice: Combined nose and throat swabDevice: Saliva swab

Arm 4 - Self-collected RAT, saliva, CTDN

EXPERIMENTAL

In children 1 month -5 years, the child/parent/guardian collects the three samples, in order of patient/parent preference. Saliva and CTDN samples will be tested on the SARS-CoV-2 laboratory panel (Allplex™ SARS-CoV-2 Assay - Seegene Inc), RAT test kit will be Abbott PanBio

Device: Combined nose and throat swabDevice: Saliva swabDiagnostic Test: Abbott Panbio™ COVID-19 antigen self-test kit

Interventions

Rhinoswab JuniorDEVICE

Rhinoswab Junior is a single use self-administered nasal swab intended to collect clinical specimens from the patient's nasal passages

Arm 1 - Clinician Collected/supervised Rhinoswab first, then CTDN swabArm 2 - Clinician Collected/supervised CTDN swab first, then RhinoswabArm 3 - Self-collected Rhinoswab, saliva swab, CTDN
Combined nose and throat swabDEVICE

Combined nose and throat swab (standard of care)

Arm 1 - Clinician Collected/supervised Rhinoswab first, then CTDN swabArm 2 - Clinician Collected/supervised CTDN swab first, then RhinoswabArm 3 - Self-collected Rhinoswab, saliva swab, CTDNArm 4 - Self-collected RAT, saliva, CTDN
Saliva swabDEVICE

Saliva swab

Arm 3 - Self-collected Rhinoswab, saliva swab, CTDNArm 4 - Self-collected RAT, saliva, CTDN
Abbott Panbio™ COVID-19 antigen self-test kitDIAGNOSTIC_TEST

COVID-19 antigen self-test kit for the screening of active COVID-19 infection. It is a single-use, in vitro, visually read rapid immunoassay that uses a human nasal swab specimen for the qualitative detection of nucleocapsid protein SARS-CoV-2 antigen. It is intended to be used manually by untrained lay users (self testing) in a private setting.

Arm 4 - Self-collected RAT, saliva, CTDN

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Symptomatic and requiring a COVID-19 test at RCH or confirmed/suspected COVID-19 at home.
  • Aged between 1 month -18 years old.
  • Parent/guardian present.
  • Parents/self are able to provide consent.

You may not qualify if:

  • \< 1 month or \>18 years old.
  • Recent head or neck surgery
  • Inability (e.g. non-English speaking and if no interpreter is available) or unwillingness to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shidan Tosif

Parkville, Victoria, 3052, Australia

Location

Related Publications (2)

  • Tosif S, Lee LY, Nguyen J, Overmars I, Selman C, Grobler AC, McMinn A, Waller G, McNab S, Jarvis T, Steer A, Babl FE, Daley A, Crawford NW. A novel anterior nasal swab to detect respiratory viruses: a prospective study of diagnostic accuracy. BMC Pediatr. 2023 Apr 28;23(1):201. doi: 10.1186/s12887-023-03976-5.

    PMID: 37106344DERIVED

  • Tosif S, Lee LY, Nguyen J, McMinn A, Selman C, Grobler AC, Daley A, Crawford NW. Stick with the nose...Saliva rapid antigen testing is not a viable method for testing children under 5 years old. J Paediatr Child Health. 2023 Feb;59(2):258-263. doi: 10.1111/jpc.16277. Epub 2022 Nov 18.

    PMID: 36401338DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: The study is organised sequentially into three phases due to research capacity Phase 1: The first 250 participants (5-18 years) will be randomly assigned to Arm 1 and Arm 2 for the clinician collected/supervised phase. Phase 2: 50 participants (5-18 years) will be allocated to Arm 3 for the self-collected Rhinoswab/saliva/combined nose+throat swab. Phase 3: 50 subsequent participants (1m - 5 years) will be allocated to Arm 4 for the self-collect throat+nose/saliva/RAT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2021

First Posted

September 14, 2021

Study Start

August 26, 2021

Primary Completion

January 26, 2022

Study Completion

August 28, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Beginning 12 months following analysis and article publication, the following will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access: • Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures and appendices).

Time Frame
Beginning 12 months following analysis and article publication

Locations

AU(1)