Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000512921
Ethics application status
Approved
Date submitted
29/03/2020
Date registered
27/04/2020
Date last updated
26/04/2023
Date data sharing statement initially provided
27/04/2020
Date results information initially provided
26/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
SARS-CoV2 in children presenting to hospital: A repeating point prevalence study during the COVID-19 pandemic in South East Queensland
Scientific title
SARS-CoV2 in children presenting to hospital: A repeating point prevalence study during the COVID-19 pandemic in South East Queensland
Secondary ID [1] 300882 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronavirus 316815 0
Viral infections 316816 0
Condition category
Condition code
Infection 315023 315023 0 0
Studies of infection and infectious agents
Public Health 315068 315068 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All children presenting or admitted to hospital and pre-defined screening days will be tested for coronavirus, irrespective if they meet current COVID-19 testing guidelines. Screening days will occur on 1 day per week for 3 months. For children who are admitted to hospital who have previously tested negative for SARS-CoV2 infection, repeat testing will only be performed if more than 72 hours have elapsed since the last swab collection'

Data will be collected form participants from the time of screening until 14 days after discharge from hospital.

Baseline screening and data collection
Demographic and clinical data will be retrospectively collected from the electronic medical record or parents by research staff. This information will include (but is not limited to):
- Age
- Sex
- Indigenous
- Postcode
- Reason for presentation or admission
- First set of vital signs on the day of testing
- Fever and symptom history from parent or guardian
- Past medical history and co-morbidities
- Travel history in past 14 days (including domestic travel)
- Contact with known SARS-CoV2 positive people
- Attendance at school or other child care facility in the past 14 days
- Prior testing undertaken, and details of test (date, result)

Discharge information
Data will be retrospectively collected after patient discharge and include:
- Discharge diagnosis
- Bacterial culture, PCR or serology collected during admission and result
- Viral PCR or serology collected during admission and results
- Emergency Department length of stay
- If admitted, hospital length of stay
- Need for intensive care admission and/or transfer to high level care
- Need for invasive ventilation
- Need for other organ supports (cardiovascular, renal replacement, etc)
- Outcome of admission (Recovered – no new disability or organ dysfunction, Recovered with new disability or organ dysfunction, Death)

Electronic Medical record follow up (day 14)
Each participant’s electronic medical record will be reviewed at day 14 to collect information on hospital representations and readmissions. Data collected from the medical record will include:
- Number of emergency department presentations and/or hospital admissions
- Reason for representation (infection/non-infection)
- SARS-CoV2 testing result (positive/negative/not tested)
- Discharge destination

Sample collection and processing
In children less than 12 years of age a nasal swab (Norgen Biotek Corporation) will be collected using standard hospital practice and PPE in accordance with current infection control guidance. In children aged over 12 years a combined oropharyngeal and nasal swab will be collected. RNA will be extracted using commercially available kits (Qiagen, Germany) and analysed by PCR on a quant studio.

In participants undergoing blood collection for clinical reasons, an additional 3mLs will be collected into a PAXgene tube. For whole blood samples RNA will be extracted from PAXgene tubes using a Maxwell RSC automated RNA extraction instrument using the commercially available Maxwell RNA Tissue Kit (Promega Corporation, WI, USA. Immune gene expression analysis will be performed using a commercially available NanoString nCounter Immune profiling panel (Nanostring Technologies, WA, USA). The panel includes 770 immune genes.

Samples will be transported to Griffith University for testing as a batch, in accordance with standards for the transport of biological samples.

Any samples that record a positive result for SARS-CoV2 on testing at the Griffith University laboratory will be referred to the Pathology Queensland laboratory at Gold Coast University for confirmatory testing and reporting through standard local and public health protocols. Results of negative results will not be reported to the participating families by the study team.

De-identified samples will be securely stored in the Gold Coast Biobank at Griffith University after completion of testing.
Intervention code [1] 317208 0
Diagnosis / Prognosis
Comparator / control treatment
For the purposes of the time series analysis historical hospital presentation, admission and diagnosis for the period January 2017 to December 2019 will be collected and analysed from Gold Coast University Hospital information systems and included in the time series analysis model.
Control group
Historical

Outcomes
Primary outcome [1] 323323 0
The primary outcome of this study is the proportion of children who test positive for SARS-CoV2 infection by PCR testing of upper airway swabs when presenting to an Emergency Department or admitted to hospital for any reason.
Timepoint [1] 323323 0
This is a repeating point prevalence study. The point prevalence will be calculated for each screening day and changes analysed over the duration of the 3 month study
Secondary outcome [1] 381553 0
Proportion of children with respiratory symptoms on clinical examination who test positive to SARS-CoV2 infection by PCR
Timepoint [1] 381553 0
This is a repeating point prevalence study. The point prevalence will be calculated for each screening day and changes analysed over the duration of the 3-month study
Secondary outcome [2] 381554 0
Proportion of children with only upper respiratory symptoms and signs on clinical examination who test positive to SARS-CoV2 infection by PCR
Timepoint [2] 381554 0
This is a repeating point prevalence study. The point prevalence will be calculated for each screening day and changes analysed over the duration of the 3-month study
Secondary outcome [3] 381555 0
Proportion of children presenting with lower respiratory symptoms and signs on clinical examination who test positive to SARS-CoV2 infection by PCR
Timepoint [3] 381555 0
This is a repeating point prevalence study. The point prevalence will be calculated for each screening day and changes analysed over the duration of the 3 month study
Secondary outcome [4] 381556 0
Proportion of children with other infective symptoms (fever without focus, gastroenteritis, etc.) on history or clinical examination who test positive to SARS-CoV2 infection by PCR
Timepoint [4] 381556 0
This is a repeating point prevalence study. The point prevalence will be calculated for each screening day and changes analysed over the duration of the 3 month study
Secondary outcome [5] 381557 0
Proportion of children who present for non-infective reasons assessed on review of medical records who test positive to SARS-CoV2 infection by PCR
Timepoint [5] 381557 0
This is a repeating point prevalence study. The point prevalence will be calculated for each screening day and changes analysed over the duration of the 3-month study
Secondary outcome [6] 381558 0
Proportion of children with SARS-CoV2 proven infection on PCR testing who are also positive for other respiratory virus on PCR testing
Timepoint [6] 381558 0
This is a repeating point prevalence study. The point prevalence will be calculated for each screening day and changes analysed over the duration of the 3 month study
Secondary outcome [7] 381559 0
Proportion of children with SARS-CoV2 proven infection on PCR testing who are also positive for a bacterial infection by microbiological, serological or PCR testing
Timepoint [7] 381559 0
This is a repeating point prevalence study. The point prevalence will be calculated for each screening day and changes analysed over the duration of the 3 month study
Secondary outcome [8] 381684 0
Time series analysis of SARS-CoV2 infections diagnosed on PCR testing over the 3 month study period
Timepoint [8] 381684 0
This is a repeating point prevalence study. The point prevalence will be calculated for each screening day and changes analysed over the duration of the 3 month study
Secondary outcome [9] 381685 0
Time series analysis of admission rates compared with historical trends of admission rates assessed by review of medical records
Timepoint [9] 381685 0
This is a repeating point prevalence study. The admission rate will be calculated for each screening day and changes analysed over the duration of the 3 month study and compared with historical trends of admission rates.
Secondary outcome [10] 382352 0
Time series analysis of critical care admission rates compared with historical trends of critical care admission rates assessed by review of medical records
Timepoint [10] 382352 0
This is a repeating point prevalence study. The critical care admission rate will be calculated for each screening day and changes analysed over the duration of the 3 month study and compared with historical trends of critical care admission rates.
Secondary outcome [11] 382353 0
Time series analysis of length of stay compared with historical trends of length of stay assessed by review of medical records
Timepoint [11] 382353 0
This is a repeating point prevalence study. The length of stay will be calculated for each screening day and changes analysed over the duration of the 3 month study and compared with historical trends of length of stay.
Secondary outcome [12] 382354 0
Time series analysis of representation rate compared with historical trends of representation rate assessed by review of medical records
Timepoint [12] 382354 0
This is a repeating point prevalence study. The representation rate will be calculated for each screening day and changes analysed over the duration of the 3 month study and compared with historical trends of representation rates.
Secondary outcome [13] 382355 0
Time series analysis of mortality rate compared with historical trends of mortality rate assessed by review of medical records
Timepoint [13] 382355 0
This is a repeating point prevalence study. The mortality rate will be calculated for each screening day and changes analysed over the duration of the 3 month study and compared with historical trends of mortality rates.
Secondary outcome [14] 382356 0
Time series analysis of children with co-infection of PCR detected SARS-CoV2 and another respiratory virus detected on PCR testing with comparision with historical data for admission rates assessed by review of medical records.
Timepoint [14] 382356 0
This is a repeating point prevalence study. The admission rate will be calculated for each screening day and changes analysed over the duration of the 3 month study and compared with historical trends of admission rates.
Secondary outcome [15] 382357 0
Time series analysis of children with co-infection of PCR detected SARS-CoV2 and another respiratory virus detected on PCR testing with comparision with historical data for critical care admission rates assessed by review of medical records.
Timepoint [15] 382357 0
This is a repeating point prevalence study. The critical care admission rate will be calculated for each screening day and changes analysed over the duration of the 3 month study and compared with historical trends of critical care admission rates.
Secondary outcome [16] 382358 0
Time series analysis of children with co-infection of PCR detected SARS-CoV2 and another respiratory virus detected on PCR testing with comparision with historical data for length of stay assessed by review of medical records.
Timepoint [16] 382358 0
This is a repeating point prevalence study. The length of stay will be calculated for each screening day and changes analysed over the duration of the 3 month study and compared with historical trends of length of stay.
Secondary outcome [17] 382359 0
Time series analysis of children with co-infection of PCR detected SARS-CoV2 and another respiratory virus detected on PCR testing with comparision with historical data for representation rate assessed by review of medical records.
Timepoint [17] 382359 0
This is a repeating point prevalence study. The representation rate will be calculated for each screening day and changes analysed over the duration of the 3 month study and compared with historical trends of representation rates.
Secondary outcome [18] 382360 0
Time series analysis of children with co-infection of PCR detected SARS-CoV2 and another respiratory virus detected on PCR testing with comparision with historical data for mortality rate assessed by review of medical records.
Timepoint [18] 382360 0
This is a repeating point prevalence study. The mortality rate will be calculated for each screening day and changes analysed over the duration of the 3 month study and compared with historical trends of mortality rates.

Eligibility
Key inclusion criteria
On the pre-defined day of patient screening, each participant must meet all the following criteria to be enrolled in this study:
• Is between the ages of 0 and 16 years at enrolment
• Is admitted to the Gold Coast University Hospital paediatric inpatient unit, Children’s Critical Care Unit or presenting to the emergency department at Gold Coast University Hospital
• Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant’s behalf.
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to nasal swab collection

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data will be analysed using simple descriptive and inferential statistics. To report the results of the principal measures descriptive statistics including counts and proportions will be calculated. Where appropriate, means and 95% confidence intervals for means will be reported, or medians and inter-quartile ranges, depending on the data. Differences in principal outcome measures by age group and presentation type will be assessed using inferential statistics (t-test, Mann-Whitney U test, or chi-square test depending on the measure).

Simple descriptive statistics will be reported for all other measures (proportions).

Time-series Analysis:
It cannot be assumed that the prevalence of SARS-CoV2 infection each week is independent from the weeks prior or to come, and for this reason we will employ a time-series analysis.

Two models will be built: one on ED presentations of children aged less than 16 years and the other on hospital admissions of this age group.

Background day-to-day practice variation (historical white noise) presentations or admissions will be included in the model using the Box & Jenkins method of moving average parameters (ARIMA). These series will be created using historic weekly data on presentations (or admissions) from 2017-2019, as available from EDIS and HBCiS. Admissions will not include short stay admissions.

Historic trends in the weekly counts of certain diagnoses in children for the period 2017-2019 will also be created for the model, based on principal diagnosis (ICD-10) codes.

Two age ratio variables will be created to create a trend of the number of infants aged less than 12 months as a total of all ED presentations (or admissions) to children aged less than 16 years of age (Infant ratio), and teenagers (13-16 year olds, teenager ratio), as a proportion of all presentations (or admissions).

Time series analysis will be done using R, as described by Shumway and Stoffer.

In addition, the number of infections of other respiratory viruses diagnosed by PCR testing and SARS-CoV2 co-infections amongst the sample will be presented in table form, with their outcomes (e.g. hospital admission, Critical Care admission, inpatient length of stay, representations, and mortality).

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
29/04/2020
Actual
29/04/2020
Date of last participant enrolment
Anticipated
30/08/2020
Actual
31/05/2020
Date of last data collection
Anticipated
18/09/2020
Actual
Sample size
Target
400
Accrual to date
Final
192
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16162 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 29703 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 305331 0
Hospital
Name [1] 305331 0
Gold Coast University Hospital
Country [1] 305331 0
Australia
Funding source category [2] 305368 0
University
Name [2] 305368 0
Griffith University
Country [2] 305368 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Blvd
Southport, Queensland 4215
Country
Australia
Secondary sponsor category [1] 305700 0
None
Name [1] 305700 0
N/A
Address [1] 305700 0
N/A
Country [1] 305700 0
Other collaborator category [1] 281253 0
University
Name [1] 281253 0
Grittith University
Address [1] 281253 0
Griffith University - Gold Coast campus
1 Parklands Drive,
Southport, Q 4215
Country [1] 281253 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305668 0
Gold Coast Hospital and Health Service HREC
Ethics committee address [1] 305668 0
1 Hospital Blvd
Southport, Queensland 4215
Ethics committee country [1] 305668 0
Australia
Date submitted for ethics approval [1] 305668 0
31/03/2020
Approval date [1] 305668 0
16/04/2020
Ethics approval number [1] 305668 0
HREC/2020/QGC/63198

Summary
Brief summary
Novel coronavirus infection, named COVID-19 by the WHO in early February has reached pandemic scale and now been diagnosed worldwide. Currently over 450k infections and 20k deaths have been reported, with these numbers increasing rapidly. While international vaccine research is being accelerated there are no treatments currently recognised for use in COVID-19.

International experience to date has indicated the children are relatively spared from the severe disease seen in adults, with few children around the world requiring invasive ventilatory support. The mechanisms behind this different expression of disease severity is the subject of ongoing studies.

While children do not experience severe disease, they are thought to acquire SARS-CoV2 infections and remain relatively well or completely asymptomatic. In addition, the symptoms expressed by many children are similar to other childhood viral infections such as Respiratory Syncytial Virus (RSV) or Influenza. This lack of defining symptoms makes testing criteria and criteria for self-isolation difficult to apply to the paediatric population. In addition, this lack of symptoms makes it more likely for children to remain at school or in the community and potentially spread the SARS CoV2 infection to others with whom they are in contact.

This study aims to quantify the presence of infection in children presenting to a metropolitan children’s emergency department and admitted to a children’s inpatient ward. This information can be used by governments and health authorities to inform policy around social distancing, self-isolation and testing criteria in this population.


This is a repeating point prevalence study, sampling children presenting to the emergency department (ED) or admitted as an inpatient to the hospital on pre-defined days.

Sampling will occur on a weekly basis, preferably on the same day each week although this may be varied for operational reasons. Screening for the inpatient ward and ED may occur on separate days to limit strain on limited nursing resources during this period.

Children who present or are admitted to hospital with known SARS-CoV2 infection will be included in the study, however repeat testing is not performed on these children. For children who are admitted to hospital who have previously tested negative for SARS-CoV2 infection, repeat testing will only be performed if more than 72 hours have elapsed since the last swab collection
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 101158 0
A/Prof Shane George
Address 101158 0
Department of Emergency Medicine
Gold Coast University Hospital
1 Hospital Blvd
Southport, Queensland 4215
Country 101158 0
Australia
Phone 101158 0
+61 7 5687 0000
Fax 101158 0
Email 101158 0
shane.george@uq.edu.au
Contact person for public queries
Name 101159 0
A/Prof Shane George
Address 101159 0
Department of Emergency Medicine
Gold Coast University Hospital
1 Hospital Blvd
Southport, Queensland 4215
Country 101159 0
Australia
Phone 101159 0
+61 7 5687 0000
Fax 101159 0
Email 101159 0
shane.george@uq.edu.au
Contact person for scientific queries
Name 101160 0
A/Prof Shane George
Address 101160 0
Department of Emergency Medicine
Gold Coast University Hospital
1 Hospital Blvd
Southport, Queensland 4215
Country 101160 0
Australia
Phone 101160 0
+61 7 5687 0000
Fax 101160 0
Email 101160 0
shane.george@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data collected can be shared in the context of relevant ethical and regulatory requirements
When will data be available (start and end dates)?
Data will be available once analysis has been completed for this study for a period of 5 years after analysis
Available to whom?
Researcher who request the data for a specific project that has IRB/ethics approval.
Available for what types of analyses?
Data can be used with permission of the investgators for any purposes provided it does not contravene ethics or regulatory requirements
How or where can data be obtained?
By contacting the investgators by email (shane.george@uq.edu.au)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.