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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12620000487910
Ethics application status
Approved
Date submitted
8/04/2020
Date registered
20/04/2020
Date last updated
10/05/2023
Date data sharing statement initially provided
20/04/2020
Date results information initially provided
10/05/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
Study evaluating Coronavirus (COVID-19) nasal/oral swab results compared to blood antibody results in COVID-19 clinic patients.
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Scientific title
Retrospective and prospective study evaluating the sensitivity of upper respiratory swabs for SARS-CoV-2(COVID-19) NAT by determining the prevalence of SARS-CoV-2 antibody seroconversion following an initial negative swab in participants that have presented to the COVID-19 clinic
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Secondary ID [1]
300967
0
None
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Universal Trial Number (UTN)
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Trial acronym
COVIDCONVERT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronavirus Disease 19 (COVID-19)
316995
0
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SARS-CoV-2
316996
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Condition category
Condition code
Infection
315158
315158
0
0
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Other infectious diseases
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Public Health
315159
315159
0
0
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Other public health
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Respiratory
315273
315273
0
0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Coronovirus Screening Clinic Participants
Participants have SARS-CoV-2 IgG, IgA and IgM antibody serum sample analysed approximately 14 days after developing Coronavirus symptoms. Upon completion of blood sampling, no further follow up is required. Data to be collected for the study will include general patient demographics, medical history, baseline SARS-CoV-2 NAT pathology results, SARS-CoV-2 Risk assessment and symptom assessment.
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Intervention code [1]
317288
0
Early Detection / Screening
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Intervention code [2]
317289
0
Diagnosis / Prognosis
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Comparator / control treatment
SARS-CoV-2 NAT Nasal/oral swab (Control/Comparator) - this is taken at the Coronavirus Clinic when the patient presents and meets the current health department criteria for testing.
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Control group
Active
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Outcomes
Primary outcome [1]
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To determine proportion of people with nucleic acid test (NAT) negative nasopharyngeal swab for SARS-CoV-2 (nasopharyngeal NAT) while exhibiting symptoms consistent with COVID-19 disease who then develop SARS-CoV-2 antibody seroconversion prior to, and during, the development of widespread community transmission.
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Assessment method [1]
323421
0
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Timepoint [1]
323421
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Approximately 14 to 28 days after developing Coronavirus symptoms
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Secondary outcome [1]
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To collect epidemiological and symptom data to determine if there are potential prognostic and diagnostic variables. There may be common trends with regard to transmission and presentation of the virus that have not been previously identified. Data to be collected for the study will include general patient demographics, medical history, SARS-CoV-2 NAT pathology results, SARS-CoV-2 Risk assessment and symptom assessment.
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Assessment method [1]
381884
0
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Timepoint [1]
381884
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Measured over duration of trial - approximately 12 months from last patient registered
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Eligibility
Key inclusion criteria
• Participants aged 18 years or over
• Participants who have attended Albury-Wodonga Health Coronavirus Screening clinic and have had a NP swab collected for SARS-CoV-2 NAT
.• Both participants that have returned a negative or a positive swab will be included in the study.
• Participants must be accessible for follow up testing
• Able to read, write and understand English Participant Information and Consent Form
• Signed Participant Information and Consent Form
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Participants under 18 years of age
• Unwilling to be contacted for follow up testing
• Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
• Research study personnel as identified in this Protocol
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
7/04/2020
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Date of last participant enrolment
Anticipated
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Actual
19/06/2020
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Date of last data collection
Anticipated
7/04/2021
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Actual
23/01/2021
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Sample size
Target
500
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Accrual to date
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Final
103
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Albury Wodonga Health - Albury campus - Albury
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Recruitment hospital [2]
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Albury Wodonga Health - Wodonga campus - Wodonga
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Recruitment postcode(s) [1]
29949
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2640 - Albury
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Recruitment postcode(s) [2]
29950
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3690 - Wodonga
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Albury Wodonga Health
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Address [1]
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Borella Rd, Albury NSW 2640
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Country [1]
305413
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Australia
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Funding source category [2]
305414
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Other
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Name [2]
305414
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Border Medical Oncology Research Unit
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Address [2]
305414
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Albury Wodonga Regional Cancer Centre
Level 1 201-239 Borella Rd
Albury NSW 2640
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Country [2]
305414
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Australia
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Primary sponsor type
Hospital
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Name
Albury Wodonga Health
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Address
Borella Rd, Albury NSW 2640
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Country
Australia
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Secondary sponsor category [1]
305804
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Other
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Name [1]
305804
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Border Medical Oncology Research Unit
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Address [1]
305804
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Albury Wodonga Regional Cancer Centre
Level 1 201-239 Borella Rd
Albury NSW 2640
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Country [1]
305804
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305735
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Albury Wodonga Human Research Ethics Committee
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Ethics committee address [1]
305735
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Albury Wodonga Health
Borella Rd, Albury NSW 2640
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Ethics committee country [1]
305735
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Australia
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Date submitted for ethics approval [1]
305735
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01/04/2020
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Approval date [1]
305735
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07/04/2020
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Ethics approval number [1]
305735
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LNR-85-4-2020
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Summary
Brief summary
This study will compare standard of care nasopharyngeal swab NAT results to the presence of SARS-CoV-2 IgG, IgA and IgM antibodies approximately 14 days after initial onset of symptoms in intermediate/high risk participants presenting to the Albury Wodonga Health Coronavirus Clinic.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
101402
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Dr Justin Jackson
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Address
101402
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Albury Wodonga Health
Borella Rd, Albury NSW 2640
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Country
101402
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Australia
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Phone
101402
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+61 2 6058 4444
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Fax
101402
0
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Email
101402
0
[email protected]
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Contact person for public queries
Name
101403
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Mrs Jacqui McBurnie
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Address
101403
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Border Medical Oncology Research Unit
Albury Wodonga Regional Cancer Centre
Level 1 201-239 Borella Rd
Albury NSW 2640
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Country
101403
0
Australia
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Phone
101403
0
+61 2 6064 1508
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Fax
101403
0
+61 2 6064 1501
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Email
101403
0
[email protected]
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Contact person for scientific queries
Name
101404
0
Dr Justin Jackson
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Address
101404
0
Albury Wodonga Health
Borella Rd, Albury NSW 2640
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Country
101404
0
Australia
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Phone
101404
0
+61 2 6058 4444
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Fax
101404
0
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Email
101404
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Beginning 6 months following analysis and article publications, the following may be made available long-term for use by future researchers:
Individual participant data that underlie the results reported in our articles after de-identification (text, tables, figures and appendices)
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When will data be available (start and end dates)?
Beginning 6 months following analysis and article publications, for long-term use, no end date
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Available to whom?
Researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept Border Medical Oncology Research Unit's conditions, under a collaborator agreement
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Available for what types of analyses?
Only to achieve the aims in the approved research proposal
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How or where can data be obtained?
Subject to approval from Principal Investigator - Dr Justin Jackson (
[email protected]
)
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
SARS-CoV-2 Seroprevalence in a Cohort of Internati...
[
More Details
]
379586-(Uploaded-10-05-2023-14-16-33)-Journal results publication.pdf
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
SARS-CoV-2 Seroprevalence in a Cohort of International Travellers Returning to Rural Australia: Enablers and Barriers to Containment of COVID-19
2023
https://doi.org/10.1016/j.anzjph.2022.100003
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF