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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
8/09/2020
Date data sharing statement initially provided
20/04/2020
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.
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
Secondary ID [1] 300967 0
None
Universal Trial Number (UTN)
Trial acronym
COVIDCONVERT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronavirus Disease 19 (COVID-19) 316995 0
SARS-CoV-2 316996 0
Condition category
Condition code
Infection 315158 315158 0 0
Other infectious diseases
Public Health 315159 315159 0 0
Other public health
Respiratory 315273 315273 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
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.

Intervention code [1] 317288 0
Early Detection / Screening
Intervention code [2] 317289 0
Diagnosis / Prognosis
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.


Control group
Active

Outcomes
Primary outcome [1] 323421 0
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.
Timepoint [1] 323421 0
Approximately 14 to 28 days after developing Coronavirus symptoms
Secondary outcome [1] 381884 0
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.
Timepoint [1] 381884 0
Measured over duration of trial - approximately 12 months from last patient registered

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 16404 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [2] 16405 0
Albury Wodonga Health - Wodonga campus - Wodonga
Recruitment postcode(s) [1] 29949 0
2640 - Albury
Recruitment postcode(s) [2] 29950 0
3690 - Wodonga

Funding & Sponsors
Funding source category [1] 305413 0
Hospital
Name [1] 305413 0
Albury Wodonga Health
Address [1] 305413 0
Borella Rd, Albury NSW 2640
Country [1] 305413 0
Australia
Funding source category [2] 305414 0
Other
Name [2] 305414 0
Border Medical Oncology Research Unit
Address [2] 305414 0
Albury Wodonga Regional Cancer Centre
Level 1 201-239 Borella Rd
Albury NSW 2640
Country [2] 305414 0
Australia
Primary sponsor type
Hospital
Name
Albury Wodonga Health
Address
Borella Rd, Albury NSW 2640
Country
Australia
Secondary sponsor category [1] 305804 0
Other
Name [1] 305804 0
Border Medical Oncology Research Unit
Address [1] 305804 0
Albury Wodonga Regional Cancer Centre
Level 1 201-239 Borella Rd
Albury NSW 2640
Country [1] 305804 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305735 0
Albury Wodonga Human Research Ethics Committee
Ethics committee address [1] 305735 0
Albury Wodonga Health
Borella Rd, Albury NSW 2640
Ethics committee country [1] 305735 0
Australia
Date submitted for ethics approval [1] 305735 0
01/04/2020
Approval date [1] 305735 0
07/04/2020
Ethics approval number [1] 305735 0
LNR-85-4-2020

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101402 0
Dr Justin Jackson
Address 101402 0
Albury Wodonga Health
Borella Rd, Albury NSW 2640
Country 101402 0
Australia
Phone 101402 0
+61 2 6058 4444
Fax 101402 0
Email 101402 0
justin.jackson@awh.org.au
Contact person for public queries
Name 101403 0
Mrs Jacqui McBurnie
Address 101403 0
Border Medical Oncology Research Unit
Albury Wodonga Regional Cancer Centre
Level 1 201-239 Borella Rd
Albury NSW 2640
Country 101403 0
Australia
Phone 101403 0
+61 2 6064 1508
Fax 101403 0
+61 2 6064 1501
Email 101403 0
jmcburnie@bordemedonc.com.au
Contact person for scientific queries
Name 101404 0
Dr Justin Jackson
Address 101404 0
Albury Wodonga Health
Borella Rd, Albury NSW 2640
Country 101404 0
Australia
Phone 101404 0
+61 2 6058 4444
Fax 101404 0
Email 101404 0
justin.jackson@awh.org.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?
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)
When will data be available (start and end dates)?
Beginning 6 months following analysis and article publications, for long-term use, no end date
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
Available for what types of analyses?
Only to achieve the aims in the approved research proposal
How or where can data be obtained?
Subject to approval from Principal Investigator - Dr Justin Jackson (justin.jackson@awh.org.au)
What supporting documents are/will be available?
No other documents available
Summary results
No Results