Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000493943
Ethics application status
Approved
Date submitted
17/04/2020
Date registered
20/04/2020
Date last updated
24/08/2021
Date data sharing statement initially provided
20/04/2020
Type of registration
N/A

Titles & IDs
Public title
Study evaluating Front-line health care workers serial blood COVID-19 antibody results in relation to symptom presentation
Scientific title
Prospective study evaluating the proportion of SARS-CoV-2 (COVID-19) antibody seroconversion in frontline health care workers on serial evaluation in comparison to symptom presentation.
Secondary ID [1] 301055 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) 317109 0
SARS-CoV-2 317110 0
Condition category
Condition code
Infection 315271 315271 0 0
Other infectious diseases
Public Health 315272 315272 0 0
Other public health
Respiratory 315275 315275 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
Front-line Healthcare Workers
Participants will have serial (monthly) SARS-CoV-2 IgG, IgA and IgM antibody serum sample analysed for six months and Coronavirus symptom data collection. Front-line health care worker participants will be requested to records symptoms in a diary each day. This will be reviewed monthly by a research staff member.Front-line health care worker participants who develop symptoms consistent with COVID-19 will be assessed at the Coronavirus clinic as per standard practice. Any nasopharyngeal swabs collected and tested will be compared to the symptoms diary and serology results. Upon completion of 6 months, no further follow up is required.
Intervention code [1] 317361 0
Early Detection / Screening
Intervention code [2] 317362 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323517 0
To determine the rate of front-line healthcare workers at Albury Wodonga Health who demonstrate SARS-CoV-2 antibody seroconversion
Timepoint [1] 323517 0
Monthly for six months following enrollment or until presentation of Coronavirus symptoms
Secondary outcome [1] 382124 0
To determine workplace environment exposure risk assessed by study-specific questionnaire and contact tracing.
Timepoint [1] 382124 0
Monthly for six months following enrollment or until presentation of Coronavirus symptoms
Secondary outcome [2] 382179 0
To determine rate and range of symptoms expressed by front-line healthcare workers assessed by study-specific questionnaire
Timepoint [2] 382179 0
Monthly for six months following enrollment or until presentation of Coronavirus symptoms

Eligibility
Key inclusion criteria
• Participants aged 18 years or over
• Participants who are front-line health care workers that may have cared for SARS-CoV-2 positive patients and/or been involved in testing suspected SARS-CoV-2 patients and/or work in a high-risk setting. High-risk setting is defined as the Emergency Department, Intensive Care, Medical wards caring for patients with COVID-19 or dialysis unit
• 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
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• 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
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/04/2021
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 16490 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [2] 16491 0
Albury Wodonga Health - Wodonga campus - Wodonga
Recruitment postcode(s) [1] 30040 0
2640 - Albury
Recruitment postcode(s) [2] 30041 0
3690 - Wodonga

Funding & Sponsors
Funding source category [1] 305498 0
Hospital
Name [1] 305498 0
Albury Wodonga Health
Country [1] 305498 0
Australia
Primary sponsor type
Hospital
Name
Albury Wodonga Health
Address
Borella Rd, Albury NSW 2640
Country
Australia
Secondary sponsor category [1] 305895 0
Other
Name [1] 305895 0
Border Medical Oncology Research Unit
Address [1] 305895 0
Albury Wodonga Regional Cancer Centre
Level 1 201-239 Borella Rd
Albury NSW 2640
Country [1] 305895 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305809 0
Albury Wodonga Human Research Ethics Committee
Ethics committee address [1] 305809 0
Ethics committee country [1] 305809 0
Australia
Date submitted for ethics approval [1] 305809 0
01/04/2020
Approval date [1] 305809 0
07/04/2020
Ethics approval number [1] 305809 0
LNR-85-4-2020

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

Contacts
Principal investigator
Name 101674 0
Dr Justin Jackson
Address 101674 0
Albury Wodonga Health
Borella Rd, Albury NSW 2640
Country 101674 0
Australia
Phone 101674 0
+61 2 6058 4444
Fax 101674 0
Email 101674 0
[email protected]
Contact person for public queries
Name 101675 0
Jacqui McBurnie
Address 101675 0
Border Medical Oncology Research Unit
Albury Wodonga Regional Cancer Centre
Level 1 201-239 Borella Rd
Albury NSW 2640
Country 101675 0
Australia
Phone 101675 0
+61 2 6064 1508
Fax 101675 0
+61 2 6064 1501
Email 101675 0
[email protected]
Contact person for scientific queries
Name 101676 0
Justin Jackson
Address 101676 0
Albury Wodonga Health
Borella Rd, Albury NSW 2640
Country 101676 0
Australia
Phone 101676 0
+61 2 6058 4444
Fax 101676 0
Email 101676 0
[email protected]

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 ([email protected])


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.