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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05043623
Ethics application status
Date submitted
26/08/2021
Date registered
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
COVID-19 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
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Rhinoswab Junior
Treatment: Devices - Combined nose and throat swab
Treatment: Devices - Saliva swab
Diagnosis / Prognosis - Abbott Panbio™ COVID-19 antigen self-test kit

Experimental: Arm 1 - Clinician Collected/supervised Rhinoswab first, then CTDN swab - Rhinoswab test administered and immediately followed by CTDN. Rhinoswab swab tested on respiratory panel vs CTDN swab tested on respiratory panel (standard of care).

Experimental: Arm 2 - Clinician Collected/supervised CTDN swab first, then Rhinoswab - CTDN test administered and immediately followed by Rhinoswab. CTDN swab tested on respiratory panel (standard of care) vs Rhinoswab swab tested on respiratory panel.

Experimental: Arm 3 - Self-collected Rhinoswab, saliva swab, CTDN - 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)

Experimental: Arm 4 - Self-collected RAT, saliva, CTDN - 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


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

Treatment: Devices: Combined nose and throat swab
Combined nose and throat swab (standard of care)

Treatment: Devices: Saliva swab
Saliva swab

Diagnosis / Prognosis: Abbott Panbio™ COVID-19 antigen self-test kit
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.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sensitivity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)
Timepoint [1] 0 0
5 minutes from administering test
Primary outcome [2] 0 0
Specificity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)
Timepoint [2] 0 0
5 minutes from administering test
Secondary outcome [1] 0 0
Ct-Value of respiratory viruses on Rhinoswab compared with Ct-value of respiratory viruses on CTDN (Clinician-Collected/Supervised)
Timepoint [1] 0 0
5 minutes from administering test
Secondary outcome [2] 0 0
Swab Preference Assessment (Clinician-Collected/Supervised )
Timepoint [2] 0 0
5 minutes from administering test
Secondary outcome [3] 0 0
Median Ct-value of SARS-CoV-2 on Rhinoswab vs saliva vs CTDN (Self-collected)
Timepoint [3] 0 0
5 minutes from administering test
Secondary outcome [4] 0 0
Sensitivity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)
Timepoint [4] 0 0
5 minutes from administering test
Secondary outcome [5] 0 0
Specificity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)
Timepoint [5] 0 0
5 minutes from administering test
Secondary outcome [6] 0 0
Comparison of RAT test (detected/not detected) to Ct-values for saliva and standard CTDN for SARS-CoV-2 only (Self-collected)
Timepoint [6] 0 0
15 minutes from administering test
Secondary outcome [7] 0 0
Sensitivity of RAT compared with saliva for SARS-CoV-2 only (Self-collected)
Timepoint [7] 0 0
15 minutes from administering test
Secondary outcome [8] 0 0
Sensitivity of RAT compared to standard CTDN for SARS-CoV-2 only (Self-collected)
Timepoint [8] 0 0
15 minutes from administering test
Secondary outcome [9] 0 0
Laboratory handling assessment
Timepoint [9] 0 0
5 minutes for survey, to be completed up to 14 days post the last participant enrolled

Eligibility
Key inclusion criteria
* 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.
Minimum age
1 Month
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* < 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/08/2022
Sample size
Target
Accrual to date
Final
339
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Beginning 12 months following analysis and article publication
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05043623