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Trial registered on ANZCTR


Registration number
ACTRN12625000123448
Ethics application status
Approved
Date submitted
11/12/2024
Date registered
4/02/2025
Date last updated
16/02/2025
Date data sharing statement initially provided
4/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluate the clinical performance of RESpiratory pathogen Point-Of-Care Testing in Emergency Departments (RESPOCT-ED study).
Scientific title
Evaluate the clinical performance of RESpiratory pathogen Point-Of-Care Testing in Emergency Departments (RESPOCT-ED study).
Secondary ID [1] 313516 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
RESPOCT-ED study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 335949 0
Condition category
Condition code
Respiratory 332539 332539 0 0
Other respiratory disorders / diseases
Infection 332577 332577 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is a prospective, observational study to assess the clinical performance of the ZiP-CoVx-P2 point-of-care (POC) test for SARS-CoV-2 infection.

The ZiP-CoVx-P2 test is performed on the ZiP-P2 instrument and uses isothermal nucleic acid amplification technology to detect SARS-CoV-2 RNA in combined oropharyngeal and bilateral mid-turbinate swabs. It provides results comparable to RT-PCR with a much faster turnaround time of 10-30 minutes for immediate clinical decision-making.

The primary aim is to assess the clinical performance of the ZiP-CoVx-P2 test in detecting SARS-CoV-2 in oro-naso-pharyngeal swab samples from patients presenting to the emergency department with respiratory infection symptoms. Additionally, the study aims to evaluate the potential impact of this test on outcomes related to emergency department care.

Participants will be asked to provide two swab samples immediately after in addition to any swabs taken for routine clinical care (i.e. rapid antigen test and RT-PCR). It will take approximately 3-5 minutes to extract additional swabs for the RESPOCT-ED study. Each sample will include oropharyngeal (throat) and bilateral mid-turbinate (nasal) sample and will be collected by healthcare staff. One swab will be tested using the ZiP-CoVx-P2 platform for SARS-CoV-2 detection within the emergency department and second swab will be bio banked. The RT-PCR and RAT test results will be retrieved from the medical records.

The ZiP-CoVx-P2 test results are not provided back to the participants or are part of any clinical management. Clinical management will be based on the RT-PCR test results collected as part of routine clinical care.
Intervention code [1] 330091 0
Diagnosis / Prognosis
Comparator / control treatment
Real-time polymerase chain reaction (RT-PCR) test (Reference comparator)
Rapid Antigen Test (RATs)
NOTE: When samples are collected for routine clinical care for RT-PCR and RAT tests, the ZiP-CoVx-P2 test sample will also be collected concurrently. The results of the RT-PCR and RAT tests will be retrieved from the medical records.
Control group
Active

Outcomes
Primary outcome [1] 340057 0
The primary outcome of the study is to estimate the clinical performance of the ZiP-CoVx-P2 POC test, including clinical sensitivity compared to lab-based RT-PCR. The sensitivity and specificity will be assessed independently.
Timepoint [1] 340057 0
Participant will be asked to provide two combined nose and throat samples at single time point. No follow up sampling is required for the study.
Primary outcome [2] 340520 0
The primary outcome of the study is to estimate the clinical performance of the ZiP-CoVx-P2 POC test, including clinical specificity compared to lab-based RT-PCR.
Timepoint [2] 340520 0
Participant will be asked to provide two combined nose and throat samples at single time point. No follow up sampling is required for the study.
Secondary outcome [1] 442502 0
The clinical performance of the ZiP-CoVx-P2 point of care including clinical sensitivity compared to RATs. The clinical sensitivity and clinical specificity will be assessed independently.
Timepoint [1] 442502 0
Data will be retrieved from hospital medical records and/or pathology within one week of enrolment.
Secondary outcome [2] 442622 0
To evaluate the impact of ZiP-CoVx-P2 test on ED-related outcomes (i.e. date/time of presentation and length of stay).
Timepoint [2] 442622 0
The emergency department (ED) related outcomes will be retrieved from the medical records within one week of enrolment..
Secondary outcome [3] 444329 0
The clinical performance of the ZiP-CoVx-P2 point of care including clinical specificity compared to RATs. The clinical sensitivity and clinical specificity will be assessed independently.
Timepoint [3] 444329 0
Data will be retrieved from hospital medical records and/or pathology within one week of enrolment.
Secondary outcome [4] 444334 0
Estimate the impact of the ZiP-CoVx-P2 test on ED-related outcomes, including Presentation time: Time of patient registration
Timepoint [4] 444334 0
Data will be retrieved from the medical records within one week of enrolment.
Secondary outcome [5] 444335 0
Estimate the impact of the ZiP-CoVx-P2 test on ED-related outcomes, including Triage time: the time at which the patient was assigned a triage category, which can coincide with presentation time.
Timepoint [5] 444335 0
Data will be retrieved from the medical records within one week of enrolment.
Secondary outcome [6] 444336 0
Time of PCR test: the time at which care by a doctor, nurse or other health professional collected the SARS-CoV-2 PCR test Time to Test Results: Time to PCR test being available is the time between sample collection and the RT-PCR test results being available from the laboratory.
Timepoint [6] 444336 0
Data will be retrieved from the medical records within one week of enrolment.
Secondary outcome [7] 444337 0
Estimate the impact of the ZiP-CoVx-P2 test on ED-related outcomes, including Time of COVID-19 clearance or diagnosis: The time between the presentation time and the COVID-19 clearance time.
Timepoint [7] 444337 0
Data will be retrieved from the medical records within one week of enrolment.
Secondary outcome [8] 444338 0
Estimate the impact of the ZiP-CoVx-P2 test on ED-related outcomes, including Australasian Triage Scale (ATS) Category allocation to the patients: • Level 1 – Immediate: life threatening. • Level 2 – Emergency: could become life threatening. • Level 3 – Urgent: not life threatening. • Level 4 – Semi-urgent: not life threatening. • Level 5 – Non-urgent: needs treatment when time permits. Streamline Destination: Resus/Trauma, Cubical, Fast Track
Timepoint [8] 444338 0
Data will be retrieved from the medical records within one week of enrolment.
Secondary outcome [9] 444339 0
Time to treatment commencement or clinical decision: The time between RT-PCR testing sample collected and the start of their treatment or making the clinical decision from one of the following. o Patients physically leave the ED for admission to the hospital ward o Patients physically leave the ED for admission to an isolation ward. o Be discharged home (date and time the patient physically discharged at home)
Timepoint [9] 444339 0
Data will be retrieved from the medical records within one week of enrolment.
Secondary outcome [10] 444340 0
For COVID participants only, time to start the first dose of anti-viral medications.
Timepoint [10] 444340 0
Data will be retrieved from the medical records within one week of enrolment.
Secondary outcome [11] 444341 0
Length of stay in hospital: The time between the presentation time of the patient to the ED department and the time of the patient being discharged home.
Timepoint [11] 444341 0
Data will be retrieved from the medical records within one week of enrolment.
Secondary outcome [12] 444342 0
Length of stay in the ED department: The time between the presentation time of patients to the ED department and the time for the patient to physically leave the ED for admission to the hospital ward or an isolation ward.
Timepoint [12] 444342 0
Data will be retrieved from the medical records within one week of enrolment.

Eligibility
Key inclusion criteria
Adults with suggestive of respiratory infections where multiplex polymerase chain reaction (PCR) testing is requested as part of routine clinical care.
- Able to provide an additional two combined nose and throat swabs along with samples collected for routine clinical practice.
- Medicare eligible
- Adults who have decision-making capacity will be included in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals for whom an adequate explanation of the study cannot be provided, or comprehended, preventing them from making an informed decision about participation or formally opting out, will also be excluded from the study.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
The accuracy of the ZiP-CoVx-P2 test in the detection of the SARS-CoV-2 virus in combined oropharyngeal and bilateral mid-turbinate swabs will be analysed through the definition of the clinical sensitivity and specificity of the test when compared against an established RT-PCR standard platform and RATs.
Clinical sensitivity is the ability to detect a target marker (genetic material) associated with SARS-CoV-2; i.e., detect a true SARS-CoV-2 positive (TP) specimen. The clinical sensitivity will be analysed as:
Sensitivity= (True Positive)/((True Positive+False Negative))
Clinical specificity is the ability to recognise the absence of a target marker (genetic material) associated with SARS-CoV-2; i.e., detect a true SARS-CoV-2 negative (TN) specimen. The clinical specificity will be analysed as:
Specificity= (True Negative)/((True Negative+False Positive))
The summary of baseline characteristics will be presented as mean and standard deviation or medians and interquartile ranges for continuous data and frequencies and percentages for categorical data.
The exact Clopper-Pearson 95% confidence interval for clinical sensitivity and specificity will also be calculated.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2025
Actual
Date of last participant enrolment
Anticipated
10/02/2026
Actual
Date of last data collection
Anticipated
10/02/2026
Actual
Sample size
Target
1100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27378 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 43476 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 317965 0
Commercial sector/Industry
Name [1] 317965 0
ZiP Diagnostics Pty Ltd
Country [1] 317965 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ZiP Diagnostics Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320302 0
None
Name [1] 320302 0
Address [1] 320302 0
Country [1] 320302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316637 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316637 0
Ethics committee country [1] 316637 0
Australia
Date submitted for ethics approval [1] 316637 0
23/09/2024
Approval date [1] 316637 0
20/12/2024
Ethics approval number [1] 316637 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138494 0
Prof Biswadev Mitra
Address 138494 0
Alfred Health Emergency, 55 Commercial Rd, Melbourne VIC 3004, Australia
Country 138494 0
Australia
Phone 138494 0
+61 3 90762782
Fax 138494 0
Email 138494 0
biswadev.mitra@monash.edu
Contact person for public queries
Name 138495 0
Dr Jonathan (Jack) Richards
Address 138495 0
ZiP diagnostics Pty Ltd. 24 Cromwell Street, Collingwood, Vic 3066
Country 138495 0
Australia
Phone 138495 0
+61 03 8414 5770
Fax 138495 0
Email 138495 0
clinicaltrials@zipdiag.com
Contact person for scientific queries
Name 138496 0
Dr Jonathan (Jack) Richards
Address 138496 0
ZiP diagnostics Pty Ltd. 24 Cromwell Street, Collingwood, Vic 3066
Country 138496 0
Australia
Phone 138496 0
+61 03 8414 5770
Fax 138496 0
Email 138496 0
clinicaltrials@zipdiag.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.