Clinical trial NCT05043623: Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
Official title: Diagnosis of Respiratory Viruses in Children With Rhinoswab Junior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS CoV 2 Infection
COVID-19
Keywords: Rhinoswab Junior
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Rhinomed Pty Ltd
First posted: 2021-09-14
Enrollment: 339
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: DIAGNOSTIC

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.

Detailed description: The microbiological test of choice for detection of respiratory viruses is a reverse transcription polymerase chain reaction (RT-PCR). The test is reported as "detected" or "not-detected" to the clinician. The Ct-value is a microbiological analysis that represents the number of amplification cycles required for a target gene to exceed a threshold level, to determine a negative or positive result and is interpreted to detect respiratory viruses. The Ct-value is used to measure viral load.

SARS-CoV-2, the virus that causes COVID-19, is a respiratory virus of specific interest. SARS-CoV-2 is detected in the upper respiratory tract. National guidelines for diagnosing COVID-19 in Australia require a combined throat and deep nasal swab (CTDN). No other testing options are routinely recommended in Australia. However, research and international guidelines recommend nasal swabs alone for SARS-CoV-2 detection. The Center for Disease Control and Prevention (USA) currently recommend the use of an anterior nasal swab alone as a method for detection of SARS-CoV-2. A recent systematic review suggested nasal swabs are a clinically acceptable alternative specimen collection methods. In addition to satisfactory diagnostic performance, nasal swabs are potentially less invasive, and can be self-collected.

Research at the Melbourne Children's Campus has identified that the CTDN or nasopharyngeal swab, are uncomfortable and distressing for children. The fear of the test is a barrier for presentation to a health service for a SARS-CoV-2 test. Parental and child reluctance to undergo testing may impact the public health response, through under-identification of pediatric cases.

The Rhinoswab is a TGA (Therapeutic Goods Administration) approved anterior nasal swab for children and adults. The design of the Rhinoswab allows for standardisation of the site of biological sampling, as compared with CTDN swabs which are operator dependent. It is designed to be more comfortable and to collect nasal secretions for PCR testing. The Rhinoswab Junior is a smaller paediatric version that has novelty features which add interest and distraction. The child can use the swab themselves, allowing autonomy and control. The capture and elution efficiency of the Rhinoswab has been shown to be comparable, if not slightly superior, to the capture and elution efficiency to the commercially available Copan eSwab by VIDRL (Victorian Infectious Diseases Reference Laboratory) and GNOMIX analyses.

The RCH has completed over 30,000 tests in children throughout the COVID-19 Pandemic from March 2020 to June 2021 at the Respiratory Infection Clinic and Emergency Department. The RCH nurses and doctors are well placed to trial the Rhinoswab due to extensive experience in testing children, and have developed related clinical practice guidelines.

This trial aims to determine the following in children 5-18 years of age:

* To determine the sensitivity and specificity of the Rhinoswab compared to the standard CTDN swab, in detecting viruses on the respiratory panel
* To determine whether Rhinoswab is non-inferior to the standard CTDN swab by comparing Ct values
* To determine the sensitivity and specificity of the throat swab alone and deep nasal swab alone, compared with the CTDN, in detecting respiratory viruses
* To investigate the comfort and preference of the Rhinoswab compared to the CTDN swab.
* To investigate the laboratory handling of the Rhinoswab compared to the CTDN swab.
* To determine the sensitivity and specificity of the Rhinoswab compared to CTDN swab, and saliva, in detecting respiratory viruses including SARS-CoV-2.

In children 1 month to 5 years:

• To investigate sensitivity and specificity of Rapid Antigen Test (RAT) compared to CTDN swab and saliva test in detected SARS-CoV-2

Eligibility criteria: 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.

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

Primary outcomes:
measure: Sensitivity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)
timeFrame: 5 minutes from administering test
measure: Specificity of Rhinoswab compared with CTDN for 13 viruses on standard respiratory panel (Clinician collected/supervised)
timeFrame: 5 minutes from administering test
Secondary outcomes:
measure: Ct-Value of respiratory viruses on Rhinoswab compared with Ct-value of respiratory viruses on CTDN (Clinician-Collected/Supervised)
timeFrame: 5 minutes from administering test
measure: Swab Preference Assessment (Clinician-Collected/Supervised )
timeFrame: 5 minutes from administering test
measure: Median Ct-value of SARS-CoV-2 on Rhinoswab vs saliva vs CTDN (Self-collected)
timeFrame: 5 minutes from administering test
measure: Sensitivity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)
timeFrame: 5 minutes from administering test
measure: Specificity of Rhinoswab compared with CTDN for SARS-CoV-2 (Self-collected)
timeFrame: 5 minutes from administering test
measure: Comparison of RAT test (detected/not detected) to Ct-values for saliva and standard CTDN for SARS-CoV-2 only (Self-collected)
timeFrame: 15 minutes from administering test
measure: Sensitivity of RAT compared with saliva for SARS-CoV-2 only (Self-collected)
timeFrame: 15 minutes from administering test
measure: Sensitivity of RAT compared to standard CTDN for SARS-CoV-2 only (Self-collected)
timeFrame: 15 minutes from administering test
measure: Laboratory handling assessment
timeFrame: 5 minutes for survey, to be completed up to 14 days post the last participant enrolled
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Shidan Tosif
state: Victoria
Study officials:
References: