Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000107628
Ethics application status
Approved
Date submitted
20/01/2023
Date registered
31/01/2023
Date last updated
31/01/2023
Date data sharing statement initially provided
31/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
To optimise and undertake clinical validation of a new point-of-care diagnostic test for COVID-19 (CoOp study).
Scientific title
Optimisation and clinical validation of a new point-of-care diagnostic test (ZiP-CoVx-P2) for COVID-19 among SARS-CoV-2-positive adults within the Alfred Hospital care pathway (CoOp study).
Secondary ID [1] 308718 0
None
Universal Trial Number (UTN)
Trial acronym
CoOp Study
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 infection in respiratory samples 328654 0
COVID-19 328655 0
Condition category
Condition code
Infection 325666 325666 0 0
Other infectious diseases
Respiratory 325667 325667 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective observational cohort study seeking the recruitment of up to 150 SARS-CoV-2-positive individuals within the Alfred Hospital care pathway. Study participants will have a clinical encounter across two time points, the first time point occurring within 5 days after testing positive for COVID-19 (acute phase) and the second time point occurring when negative; at least 3 weeks after testing positive for COVID-19 (convalescent phase).

Study participants will provide two swabs at the acute-phase encounter and two swabs at the convalescent-phase encounter. Each swab is used to obtain an oropharyngeal (throat) and bilateral mid-turbinate (nasal) sample (i.e., combined throat and nasal swab). Samples will be self-collected. Sample self-collection instructions including sample techniques and procedures are provided, along with video instruction on nasal/throat sample collections.
Sample collection: Once consented the Research Coordinator (RC) will go over the study sampling techniques and procedures provide access to video instructions on nasal/throat sample collections and arrange a suitable time to drop off their study kit.

Given the initial study, the visit will occur when the participant is COVID-19 positive, a member of the research team will deliver the study pack to their place of residence while isolating. This pack will contain the two swabs for the throat and bilateral mid-turbinate nasal sample collection, self-collection instructions, an additional bag for storage of collected samples, and research team contact details. The RC will contact the participant either via telehealth or phone to instruct them on sample collection and answer any questions they may have.

For the second study visit, participants will have the option for the visit to occur at their place of residence or to attend to The Alfred Hospital.

The swabs, once collected, will be placed into labelled biohazard bags. These are then placed in the storage bag and kept in the fridge or esky provided until collected by the RC. The RC will collect the samples within 3 days and transport them back to The Alfred.

Sample testing:
The one swab will be used for optimisation and clinical validation of the ZiP-CoVx-P2 point-of-care test platform, to detect the presence of SARS-CoV-2 virus RNA, including estimates of test sensitivity and specificity. The ZiP-CoVx-P2 is an integrated cartridge-instrument platform that uses novel, low-cost nucleic acid amplification test (NAATs) technology. This test platform uses respiratory swabs and provides a test result within 30 minutes of sample collection.
Intervention code [1] 325184 0
Diagnosis / Prognosis
Comparator / control treatment
The other swab will be used for gold-standard comparator test, laboratory-based RT-qPCR analysis. The reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) is the gold standard technology because of its ability to amplify and detect viral nucleic acids, thus identifying people with very low levels of viral infection (i.e., high sensitivity).
Control group
Active

Outcomes
Primary outcome [1] 333512 0
The primary outcome of this study is to validate a new POC diagnostic test for the detection of SARS-CoV-2 infection and determine its performance compared to lab-based RT-qPCR (determine sensitivity and specificity).
Timepoint [1] 333512 0
Study participants will have a clinical encounter across two timepoints, the first time point occurring within 5 days after testing positive for COVID-19 (acute-phase) and the second time point occurring when negative; at least 3 weeks after testing positive for COVID-19 (convalescent phase).
Secondary outcome [1] 417346 0
None
Timepoint [1] 417346 0
None

Eligibility
Key inclusion criteria
This is a prospective observational cohort study seeking recruitment of up to 150 SARS-CoV-2 positive adults within the Alfred Hospital care pathway. Study participants will have a clinical encounter across two timepoints, the first time point occurring within 5 days after testing positive for COVID-19 (acute-phase) and the second time point occurring when negative; at least 3 weeks after testing positive for COVID-19 (convalescent phase).

Acute-phase encounter:
• Participants have been tested for SARS-CoV-2 (RAT or PCR) in the last 5 days.
• Participants have provided verbal informed consent.
• 18 years of age or older
• Participant has a suitable location where the study sample kit can be dropped-off and collected in an area that is accessible and safe for researchers.

Convalescent-phase encounter:
• Participants have previously provided samples during acute-phase of the study but there have been at least 3 weeks since the acute-phase sampling.
• Participants have provided verbal informed consent.
• 18 years of age or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
< 18 years.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Samples will be used for test optimisation and clinical validation.
Recruitment of up to 150 COVID-19 +ve participants will be sought with the intent of obtaining a minimum of 100 participant-matched samples (i.e., positive acute-phase and negative convalescent-phase samples). It is expected that there may be challenges in obtaining some of the convalescent samples. Sample size (n=100 positive and n=100 negative) has been guided by the TGA recommendations for COVID test clinical validation studies.
Data analysis to include estimates of test sensitivity and specificity.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/06/2022
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
150
Accrual to date
100
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23785 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 39235 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 312941 0
Commercial sector/Industry
Name [1] 312941 0
ZiP Diagnostics Pty Ltd
Country [1] 312941 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ZiP Diagnostics Pty Ltd
Address
24 Cromwell Street, Collingwood, Vic 3066
Country
Australia
Secondary sponsor category [1] 314631 0
None
Name [1] 314631 0
Address [1] 314631 0
Country [1] 314631 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312214 0
The Alfred Ethics Committee
Ethics committee address [1] 312214 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 312214 0
Australia
Date submitted for ethics approval [1] 312214 0
19/05/2022
Approval date [1] 312214 0
22/05/2022
Ethics approval number [1] 312214 0
Project No: 194/22

Summary
Brief summary
This is a prospective observational cohort study seeking recruitment of up to 150 SARS-CoV-2 positive individuals within the Alfred Hospital care pathway. Study participants will have a clinical encounter across two timepoints, the first time point occurring within 5 days after testing positive for COVID-19 (acute-phase) and the second time point occurring when negative; at least 3 weeks after testing positive for COVID-19 (convalescent phase).

Study participants will provide two swabs at the acute-phase encounter and two swabs at the convalescent-phase encounter. Each swab is used to obtain an oropharyngeal (throat) and bilateral mid-turbinate (nasal) sample (i.e., combined throat and nasal swab). Samples will be self-collected. All samples will be labelled with a Participant ID number, date of collection and year of birth, but will not have any other identifying information.
The samples will be used for optimisation and clinical validation of the ZiP-CoVx-P2 point-of-care test platform. For both study visits; one swab sample will be used for the test under evaluation (ZiP-CoVx-P2 test) and the other swab will be used for gold-standard comparator test (laboratory-based RT-qPCR) analysis. This study will help to optimise and undertake clinical validation of the new ZiP-CoVx-P2 test, including estimates of test sensitivity and specificity. The negative swabs collected in the convalescent phase will be used as a control for sample related variables, thus aiding the assessment of test specificity.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 123874 0
Dr James McMahon
Address 123874 0
Alfred Hospital
Address: 55 Commercial Rd, Melbourne, VIC, 3004
Country 123874 0
Australia
Phone 123874 0
+613 9076 6700
Fax 123874 0
Email 123874 0
james.mcmahon@monash.edu
Contact person for public queries
Name 123875 0
Dr Jonathan (Jack) Richards
Address 123875 0
ZiP diagnostics Pty Ltd.
24 Cromwell Street, Collingwood, Vic 3066
Country 123875 0
Australia
Phone 123875 0
+61 03 8414 5770
Fax 123875 0
Email 123875 0
jack.r@zipdiag.com
Contact person for scientific queries
Name 123876 0
Dr Jonathan (Jack) Richards
Address 123876 0
ZiP diagnostics Pty Ltd.
24 Cromwell Street, Collingwood, Vic 3066
Country 123876 0
Australia
Phone 123876 0
+61 03 8414 5770
Fax 123876 0
Email 123876 0
jack.r@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.