Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000854932
Ethics application status
Approved
Date submitted
13/08/2020
Date registered
27/08/2020
Date last updated
16/02/2022
Date data sharing statement initially provided
27/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
ADAPT-C Sub-Study: Community-based cohort of people tested for COVID-19
Scientific title
ADAPT-C Sub-Study: Community-based cohort of people tested for COVID-19- negative control community-based cohorts of people tested for SARS-CoV-2, to enable evaluation of SARS-CoV-2 serological assays and long-term COVID-19 illness.
Secondary ID [1] 302091 0
NA
Universal Trial Number (UTN)
Trial acronym
ADAPT-C
Linked study record
This study is a a sub-study of the ACTRN12620000554965 study. This study is establishing a negative control group

Health condition
Health condition(s) or problem(s) studied:
COVID 19 318604 0
Condition category
Condition code
Infection 316622 316622 0 0
Other infectious diseases
Respiratory 316719 316719 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
Participation will involve a maximum of 4 study visits to the Clinic over a 12 month period.

3x Negative Control Cohorts will be recruited

Cohort C (n=50): COVID-19 negative, other coronavirus positive

Cohort D (n=50-100): COVID-19 negative, respiratory viral panel negative, no known epidemiological risk factor for COVID-19 infection

Cohort E (n=50): COVID-19 negative, respiratory viral panel negative, known epidemiological risk factor for COVID-19 infection (close contact of known COVID-19 case, overseas travel in 2 weeks prior to testing date)

Participation will include

Blood sampling
27mLs blood collected in SST and EDTA tubes (and an optional 36mLs in ACD tubes) will be taken at each time point in the study to create a biobank of samples suitable for COVID-19 related immunovirological research, and serological assay evaluation.

Dried blood spot sampling
A dried blood spot (DBS) will be collected at each time point (in comparison to phlebotomy sampling). DBS can be self-collected by participants at home if required. DBS will be mailed to participant with instructions on self-completion using standard educational materials developed for the use of DBS in HIV and HCV research.

Health-Related Quality of Life (HRQoL) measures
Study subjects will be asked to complete standardized HRQoL questionnaires at pre-specified follow-up timepoints. Survey instruments have been selected for general health measures, response to a major event and for psychological outcomes as follows:
• Depression Scale
• Impact of Events Scale
• Somatic and Psychological Health Report (SPHERE)
• EQ-5D Functional Impact of Illness
Intervention code [1] 318325 0
Early Detection / Screening
Comparator / control treatment
The 3 negative control Cohorts recruited for this study will establish the control groups for the Main study-ADAPT Study (ACTRN12620000554965). This study is establishing a negative control group.
Control group
Active

Outcomes
Primary outcome [1] 324748 0
The biobank collection of blood samples and serological assays from SARS-CoV-2 negative population
Timepoint [1] 324748 0
Enrollment, 4 weeks. 16 weeks and 48 weeks post negative swab result
Secondary outcome [1] 385634 0
Quality of life data using Depression Scale
Timepoint [1] 385634 0
Enrollment, 4 weeks. 16 weeks and 48 weeks post negative swab result
Secondary outcome [2] 386238 0
Quality of life data using Impact of Events Scale
Timepoint [2] 386238 0
Enrollment, 4 weeks. 16 weeks and 48 weeks post negative swab result
Secondary outcome [3] 386239 0
Quality of life data using EQ5D
Timepoint [3] 386239 0
Enrollment, 4 weeks. 16 weeks and 48 weeks post negative swab result
Secondary outcome [4] 386240 0
Quality of life data using Somatic and Psychological Health Report (SPHERE) questionnaire
Timepoint [4] 386240 0
Enrollment, 4 weeks. 16 weeks and 48 weeks post negative swab result

Eligibility
Key inclusion criteria
18 years old and Over

SARS-CoV-2 negative nasopharyngeal swab RVP test

Cohort C: RVP positive for other non-SARS-CoV-2 coronavirus

Cohort D: No documented respiratory pathogens on RVP and no known epidemiological link to COVID-19 case OR epidemiological risk factor including overseas travel or cruise ship

Cohort E: No documented respiratory pathogens on RVP and a known epidemiological link to COVID-19 case OR epidemiological risk factor including overseas travel or cruise ship
Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Documented Positive SARS-CoV-2 test previously

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Descriptive statistics will be summarised by median (IQR) and counts (%-total). Differences between groups will be compared using the Student’s T test for continuous variables and the Chi-Square test for categorical variables. Logistic regression analysis will be performed to measure the association between continuous predictors and binary outcome variables. Will intend to account for potential bias by running multivariate logistic and Cox Regression models by adjusting models for the presence of absence of confounding variables

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
18/08/2020
Date of last participant enrolment
Anticipated
1/04/2022
Actual
14/12/2020
Date of last data collection
Anticipated
1/04/2023
Actual
22/07/2021
Sample size
Target
150
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306449 0
Charities/Societies/Foundations
Name [1] 306449 0
St Vincent's Clinic Foundation Grant
Country [1] 306449 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria Street
Darlinghurst
NSW
2010
Country
Australia
Secondary sponsor category [1] 306966 0
None
Name [1] 306966 0
Address [1] 306966 0
Country [1] 306966 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306655 0
St Vincent's Hospital HREC
Ethics committee address [1] 306655 0
97 to 105 Boundary Street
Darlinghurst
NSW
2010
Ethics committee country [1] 306655 0
Australia
Date submitted for ethics approval [1] 306655 0
02/06/2020
Approval date [1] 306655 0
11/06/2020
Ethics approval number [1] 306655 0

Summary
Brief summary
There is pressing urgency to better understand the pathogenesis and physiologic consequences of COVID-19. The aim of the ADAPT study is to increase scientific knowledge regarding the immune and pathophysiologic consequences of COVID-19 infection. The aim of the ADAPT-C sub-study is to create SARS-CoV-2 negative control cohorts to the ADAPT study and enable development of serological assays to manage the disease burden of SARS-CoV-2.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104574 0
A/Prof Gail Matthews
Address 104574 0
St Vincent's Hospital
IBAC
390 Victoria Street
Darlinghurst
NSW
2010
Country 104574 0
Australia
Phone 104574 0
+61 02 8382 3707
Fax 104574 0
Email 104574 0
[email protected]
Contact person for public queries
Name 104575 0
Fiona Jane Kilkenny
Address 104575 0
St Vincent's Hospital
97 to 105 Boundary street
Darlinghurst
NSW
2010
Country 104575 0
Australia
Phone 104575 0
+61 02 8382 4975
Fax 104575 0
Email 104575 0
[email protected]
Contact person for scientific queries
Name 104576 0
Gail Matthews
Address 104576 0
St Vincent's Hospital
IBAC
390 Victoria Street
Darlinghurst
NSW
2010
Country 104576 0
Australia
Phone 104576 0
+61 02 8382 3707
Fax 104576 0
Email 104576 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8794Study protocol    380379-(Uploaded-13-08-2020-15-18-24)-Study-related document.docx
8795Informed consent form    380379-(Uploaded-13-08-2020-15-18-33)-Study-related document.doc
8796Ethical approval    380379-(Uploaded-13-08-2020-15-20-14)-Study-related document.pdf



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.