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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05043623
Registration number
NCT05043623
Ethics application status
Date submitted
26/08/2021
Date registered
14/09/2021
Date last updated
8/02/2023
Titles & IDs
Public title
Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
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Scientific title
Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
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Secondary ID [1]
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HREC/77305/RCHM-2021
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
SARS CoV 2 Infection
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COVID-19
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Sensitivity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)
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Assessment method [1]
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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.
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Timepoint [1]
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5 minutes from administering test
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Primary outcome [2]
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Specificity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)
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Assessment method [2]
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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.
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Timepoint [2]
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5 minutes from administering test
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Secondary outcome [1]
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Ct-Value of respiratory viruses on Rhinoswab compared with Ct-value of respiratory viruses on CTDN (Clinician-Collected/Supervised)
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Assessment method [1]
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Median Ct-Value of respiratory viruses on Rhinoswab compared with Ct-value of respiratory viruses on CTDN for each detection will be compared. The CT value for the undetected sample will be set at the maximum number of cycles performed in the laboratory (CT value maximum of 38.73). If the upper limit of the confidence interval is more than 3 Ct-value, the two swabs will be regarded as non-inferior.
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Timepoint [1]
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5 minutes from administering test
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Secondary outcome [2]
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Swab Preference Assessment (Clinician-Collected/Supervised )
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Assessment method [2]
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The preferability for the Rhinoswab, compared to the standard sample for respiratory virus testing is determined, using the Likert scale or picture-based chart for standardised responses. Descriptive analyses will be used to describe child/parent/research preferences.
A) Child/parent/research nurse will be asked to rate comfort for each swab: Extremely Comfortable 1 to Extremely Uncomfortable 5 B) What is your preference for future testing between CTDN and Rhinoswab? C) Which swab was better CTDN vs Rhinoswab?
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Timepoint [2]
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5 minutes from administering test
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Secondary outcome [3]
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Median Ct-value of SARS-CoV-2 on Rhinoswab vs saliva vs CTDN (Self-collected)
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Assessment method [3]
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Median Ct-Value of SARS-CoV-2 on Rhinoswab, saliva and CTDN will be compared. The CT value for the undetected sample will be set at the maximum number of cycles performed in the laboratory (CT value maximum of 38.73). If the upper limit of the 95% confidence interval for the median difference is less than 3 CT, the Rhinoswab will be regarded as non-inferior.
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Timepoint [3]
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5 minutes from administering test
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Secondary outcome [4]
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Sensitivity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)
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Assessment method [4]
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Sensitivity is calculated only in the participants who tested positive for SARS-CoV-2 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.
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Timepoint [4]
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5 minutes from administering test
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Secondary outcome [5]
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Specificity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)
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Assessment method [5]
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Specificity is calculated only in participants who tested negative for SARS-CoV-2and is calculated as the proportion patients who tested negative on Rhinoswab among those who tested negative on CTDN swab.
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Timepoint [5]
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5 minutes from administering test
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Secondary outcome [6]
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Comparison of RAT test (detected/not detected) to Ct-values for saliva and standard CTDN for SARS-CoV-2 only (Self-collected)
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Assessment method [6]
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The SARS-CoV-2 results (detected/not detected) from the RAT test will be compared with Ct-values from saliva and standard CTDN swabs.
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Timepoint [6]
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15 minutes from administering test
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Secondary outcome [7]
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Sensitivity of RAT compared with saliva for SARS-CoV-2 only (Self-collected)
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Assessment method [7]
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Sensitivity is calculated only in the participants who tested positive for SARS-CoV-2 using saliva and is calculated as the proportion patients who tested positive on RAT among those who tested positive on saliva.
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Timepoint [7]
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15 minutes from administering test
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Secondary outcome [8]
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Sensitivity of RAT compared to standard CTDN for SARS-CoV-2 only (Self-collected)
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Assessment method [8]
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Sensitivity is calculated only in the participants who tested positive for SARS-CoV-2 using the CTDN swab and is calculated as the proportion patients who tested positive on RAT among those who tested positive on CTDN swab.
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Timepoint [8]
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15 minutes from administering test
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Secondary outcome [9]
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Laboratory handling assessment
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Assessment method [9]
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At the end of the study, the laboratory staff will be asked:
A) Rate the handling experience of Rhinoswab vs CTDN using a Likert scale:
Rhinoswab was easier to handle 1 to Rhinoswab was harder to handle 3 B) Was there a difference in processing the Rhinoswab versus the combined throat and deep nasal swab?: Rhinoswab was easier to process/There was no difference in processing/Rhinoswab was harder to process C) How did the Rhinoswab impact the workflow or lab efficiency compared to the standard combined throat and deep nasal swab?
1 Very easy and no impact on workflow or lab efficiency to 5 Very difficult and many complications on workflow or lab efficiency D) What benefits or challenges, did you observe when working with Rhinoswab in the lab? (Freetext)
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Timepoint [9]
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5 minutes for survey, to be completed up to 14 days post the last participant enrolled
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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.
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Minimum age
1
Month
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/08/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/08/2022
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Sample size
Target
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Accrual to date
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Final
339
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Shidan Tosif - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Rhinomed Pty Ltd
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05043623
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05043623
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