Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000066684
Ethics application status
Approved
Date submitted
23/11/2022
Date registered
19/01/2023
Date last updated
16/02/2023
Date data sharing statement initially provided
19/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Validation of ZiP-CoVx-P2 for COVID-19 point-of-care test in Ghana
(VaZico Study Ghana)
Scientific title
Clinical Validation of ZiP-CoVx-P2 for COVID-19 point-of-care test in children and adults in Ghana (VaZico Study Ghana).
Secondary ID [1] 308428 0
None
Universal Trial Number (UTN)
Trial acronym
VaZico Study Ghana
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 infection in respiratory samples 328228 0
COVID-19 328389 0
Condition category
Condition code
Infection 325278 325278 0 0
Other infectious diseases
Respiratory 325417 325417 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 multi-site prospective cross-sectional study seeking recruitment of 1000 study participants (adults and children) living around or visiting Hospitals and Community Health Clinics in Greater Accra and Central Regions of Ghana. Participants may be symptomatic or asymptomatic for respiratory symptoms. Study participants will be asked to provide two swabs where the same clean swab will be used to take an oropharyngeal (throat) sample and then followed by a bilateral mid-turbinate (nasal) sample.

Participants will be encouraged to provide a combined throat and nasal swab sample but will be given the option to provide a single sample type if they feel uncomfortable having the same swab being used to swab the throat and nose. Optionally, participants can also provide saliva samples.
The samples will be collected by trained field staff following standard operating procedures (SOPs) in the study protocol. All field staff will report to the study coordinators, who will be responsible for all activities at the field sites.

Of the two swabs collected per participant, one swab will be processed and tested on the ZiP-CoVx-P2 platform for the presence of SARS-CoV-2 virus RNA. The other will be used for RT-PCR (gold standard for SARS-CoV-2 detection). 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.

Testing on the ZiP-CoVx-P2 platform and with RT-PCR will be performed by trained research staff following the manufacturers’ instructions.
All the Vazico team members including field and lab staff will be trained to perform the following:
a. Reading the study protocol and participating in an education session on the associated study procedures.
b. Reading the ZiP-CoVx-P2 Instructions for Use, and the ZiP-P2 instrument User Manual and practising the ZiP-CoVx-P2 point-of-care molecular test platform under supervision.
c. Swab collection standard operating procedure (SOP) developed as outlined in the study protocol. All the field staff are trained to strictly adhere to the sample collection procedure as outlined. The study coordinators monitored field staff daily to ensure the field staff followed the proper procedures according to the study protocol.
Intervention code [1] 324877 0
Diagnosis / Prognosis
Comparator / control treatment
The other swab will be used for gold-standard comparator test, laboratory-based RT-qPCR analysis and viral whole genome sequencing. The reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) is the gold standard technology because of its ability 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] 333138 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.. Sensitivity and specificity will be assessed.
Timepoint [1] 333138 0
Single engagement
Secondary outcome [1] 415922 0
The secondary outcome of the study is the identification of polymorphisms, in the viral genomes, that have been associated with SARS-CoV-2 infection and/or pathogenesis, i.e., COVID-19 severity. The data will help us to understand whether certain variants are associated with COVID-19 severity (e.g., symptomatic versus asymptomatic).

The sample that tests positive either by ZiP test or RT-qPCR will be sequenced to determine the genomic sequence of the virus.
Timepoint [1] 415922 0
Single engagement

Eligibility
Key inclusion criteria
All ages and genders, Participants with or without respiratory symptoms and Participants have provided informed consent.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
The objective of this study is to optimize the ZiP-CoVx-P2 platform using throat and mid-turbinate nasal swabs, which are either positive or negative for SARS-CoV-2. Approximately, 1000 study participants living/visiting in Accra will be recruited. This sample size is estimated based on the recent surveillance data reported by the Ghana Health Service (August, 2022) – mean COVID-19 case positivity rate of 12% in communities with active transmission in Ghana. From this national prevalence estimate, we assume that the positivity rate in Greater Accra and Central regions of Ghana is 10%. Therefore, in order to obtain the 100 positive samples (i.e., recommended by WHO for nucleic acid tests validation studies), 1000 participants would have to be recruited into the study.
Analysis: Test performance (i.e. sensitivity and specificity)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/10/2022
Date of last participant enrolment
Anticipated
1/10/2023
Actual
Date of last data collection
Anticipated
1/10/2023
Actual
Sample size
Target
1000
Accrual to date
700
Final
Recruitment outside Australia
Country [1] 25146 0
Ghana
State/province [1] 25146 0

Funding & Sponsors
Funding source category [1] 312677 0
Commercial sector/Industry
Name [1] 312677 0
ZiP Diagnostics Pty Ltd
Country [1] 312677 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] 314287 0
Charities/Societies/Foundations
Name [1] 314287 0
British Society for Antimicrobial Chemotherapy
Address [1] 314287 0
53 Regent Place
Birmingham
B1 3NJ
Country [1] 314287 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311979 0
The Council for Scientific and lndustrial Research (CSIR) lnstitutional Review Board (lRB)
Ethics committee address [1] 311979 0
CSIR-Water Research Institute, GA-018-9651, Second CSIR Close, Airport Residential, Accra, Ghana
Ethics committee country [1] 311979 0
Ghana
Date submitted for ethics approval [1] 311979 0
06/09/2022
Approval date [1] 311979 0
13/10/2022
Ethics approval number [1] 311979 0
CSIR/IRB/AL/VOL I-023 (RPN 017/CSIR-IRB/2022

Summary
Brief summary
Objective: To undertake clinical validation of a new point-of-care diagnostic test for SARS-CoV-2.
Study Design: This is a multi-site prospective cross-sectional study seeking recruitment of 1000 study participant (adults and children) living around or visiting Hospitals and Community Health Clinics in Greater Accra and Central Regions of Ghana. Participants may be symptomatic or asymptomatic for respiratory symptoms. Study participants will provide two swabs. Each swab is used to obtain an oropharyngeal (throat) and bilateral mid-turbinate (nasal) sample. Optionally, saliva samples will be collected. Samples will be collected by the project field staff. All samples will be labelled with a participant ID number, date of collection and type of sample (throat & nasal swab) year of birth, but will not have any other identifying information.
The samples will be used for validation of the ZiP-CoVx-P2 point-of-care molecular test platform to detect the presence of SARS-CoV-2 virus RNA. One swab sample will be used for the ZiP-CoVx-P2 test and the other swab will be used for gold-standard comparator test, laboratory-based RT-qPCR analysis and viral whole genome sequencing. This study will help to optimize and undertake clinical validation of the new ZiP-CoVx-P2 test, including estimates of test sensitivity and specificity.
Outcome: This clinical validation study will include an analysis of test performance including sensitivity and specificity. The viral sequencing component of the project will help identify polymorphisms in the viral isolates that predispose an individual (symptomatic vs asymptomatic, male vs female) to variant-specific infections.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 123042 0
Dr Charles Narh
Address 123042 0
ZiP Diagnostics Pty Ltd
24 Cromwell Street, Collingwood, Vic 3066
Country 123042 0
Australia
Phone 123042 0
+61 03 8414 5770
Fax 123042 0
Email 123042 0
charles.n@zipdiag.com
Contact person for public queries
Name 123043 0
Dr Jonathan (Jack) Richards
Address 123043 0
ZiP diagnostics Pty Ltd.
24 Cromwell Street, Collingwood, Vic 3066
Country 123043 0
Australia
Phone 123043 0
+61 03 8414 5770
Fax 123043 0
Email 123043 0
jack.r@zipdiag.com
Contact person for scientific queries
Name 123044 0
Dr Jonathan (Jack) Richards
Address 123044 0
ZiP diagnostics Pty Ltd
24 Cromwell Street, Collingwood, Vic 3066
Country 123044 0
Australia
Phone 123044 0
+61 03 8414 5770
Fax 123044 0
Email 123044 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.