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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT05043623




Registration number
NCT05043623
Ethics application status
Date submitted
26/08/2021
Date registered
14/09/2021
Date last updated
14/09/2021

Titles & IDs
Public title
Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
Scientific title
Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
Secondary ID [1] 0 0
HREC/77305/RCHM-2021
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS CoV 2 Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Rhinoswab Junior

Treatment: Devices: Rhinoswab Junior
To determine the sensitivity and specificity of the Rhinoswab compared to the standard CTDN swab, in detecting viruses on the respiratory panel

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PCR ct value of viruses detected on respiratory panel of the Rhinoswab junior - Rhinoswab junior sample will be tested with respiratory panel and CT value recorded
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
PCR ct value of viruses detected on respiratory panel on standard of care (combined nose and throat) swab - The standard of care test (combined nose/throat) will be tested for respiratory viruses and CT value recorded
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Comfort Assessment - The comfort and preference of the Rhinoswab compared to the CTDN swab on a Likert Scale
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Laboratory Assessment - Laboratory handling assessment of Rhinoswab compared to the CTDN swab on a Likert Scale
Timepoint [3] 0 0
3 months

Eligibility
Key inclusion criteria
- Symptomatic and requiring a COVID-19 test at RCH or confirmed/suspected COVID-19 at
home.

- Aged between 4-18 years old.

- Parent/guardian present.

- Parents/self are able to provide consent.
Minimum age
4 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- <4 years old, or >18 years old.

- Previous head or neck surgery resulting in the absence of a nasal cavity (e.g.
rhinectomy).

- Inability (e.g. non-English speaking) or unwillingness to consent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Shidan Tosif - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Rhinomed Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT05043623
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shidan Tosif, MBBS FRACP PhD
Address 0 0
Country 0 0
Phone 0 0
0413484876
Fax 0 0
Email 0 0
shidan.tosif@rch.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05043623