Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000554965
Ethics application status
Approved
Date submitted
8/05/2020
Date registered
11/05/2020
Date last updated
27/02/2023
Date data sharing statement initially provided
11/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
ADAPT - COVID-19 Study - A prospective, observational cohort study at St Vincent’s Hospital Sydney
Scientific title
ADAPT - COVID-19 Study - Characterising pathophysiological, immunological and clinical outcomes relating to COVID-19 infection in the patient population of St Vincent’s Hospital Sydney.
Secondary ID [1] 301231 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ADAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 317393 0
Condition category
Condition code
Infection 315496 315496 0 0
Other infectious diseases
Respiratory 315507 315507 0 0
Other respiratory disorders / diseases
Public Health 315508 315508 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective, observational cohort study of all patients at St Vincent’s Hospital Sydney who test positive for COVID-19 infection. The cohort will consist of two components.
Cohort A - Mild disease patients recruited through the community cohorts
Cohort B - Moderate-severe patients recruited through the inpatient service at St Vincent’s Hospital Sydney.
Each patient shall be followed for a period of 12 months from the time of COVID-19 diagnosis. The study will run for 2 years in total.
The study will examine the short, medium and long term effects of COVID-19 on the immune system. The study will also examine how the immune system responds to COVID-19 to form antibodies and the long-term effects of COVID-19 on heart, lung and brain function and also a person’s mental health and effect on a person’s activities of daily living.
Intervention code [1] 317534 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323737 0
Primary outcome is the evolution of an immunological response to COVID-19 measured by COVID-19 antibody formation.
Timepoint [1] 323737 0
1, 4 and 12 months post COVID-19 diagnosis
Secondary outcome [1] 382760 0
The immunological response to COVID-19 measured by COVID-19 antibody formation.
Timepoint [1] 382760 0
1,2 and 32 weeks post COVID-19 diagnosis
Secondary outcome [2] 382761 0
To evaluate the impact of COVID-19 on respiratory function in those with moderate-severe disease using lung function tests; Dynamic Lung Volumes (Spirometry), Static Lung Volumes, Diffusion Capacity, Airway Oscillometry
Timepoint [2] 382761 0
4, 16 and 48 weeks post COVID-19 diagnosis
Secondary outcome [3] 382762 0
To characterise patient reported psychosocial outcomes following a diagnosis of COVID-19 using survey instruments selected for general health measures, response to a major event and for psychological outcomes: Depression Scale, Impact of Events Scale, SPHERE Questionnaire and EQ-5D Functional Impact of Illness.
Timepoint [3] 382762 0
2, 4, 16 and 48 weeks post COVID-19 diagnosis
Secondary outcome [4] 382763 0
To evaluate the impact of COVID-19 on neurocognitive function using the self administered version of the Cogstate computerised battery of tests.
Timepoint [4] 382763 0
4, 16 and 48 weeks post COVID-19 diagnosis
Secondary outcome [5] 382764 0
Characterise the quality of sleep in adults diagnosed with COVID-19 via Sleep Study (polysomnography).
Timepoint [5] 382764 0
16 weeks post COVID-19 diagnosis.
Secondary outcome [6] 382765 0
Change in lung microbiome over time following COVID-19 , assessed using analysis of saliva swabs by the Microbiome Research Centre, UNSW
Timepoint [6] 382765 0
1,4,16 and 48 weeks post COVID-19 diagnosis
Secondary outcome [7] 382821 0
Change in gut microbiome over time following COVID-19 , assessed using analysis of stool samples by the Microbiome Research Centre, UNSW
Timepoint [7] 382821 0
1, 4, 16 and 48 weeks post COVID_19 diagnosis.

Eligibility
Key inclusion criteria
1. Age greater than or equal to 18 years
2. Confirmed SARS-CoV-2 by nucleic acid testing
3. Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable or unwilling to provide consent
2. Death is deemed to be imminent and inevitable within the next 24 hours
3. Pregnancy (Cohort B only)

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 (percentage 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
Recruiting
Date of first participant enrolment
Anticipated
14/05/2020
Actual
14/05/2020
Date of last participant enrolment
Anticipated
1/07/2023
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
300
Accrual to date
120
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16634 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 30229 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 305681 0
Charities/Societies/Foundations
Name [1] 305681 0
St Vincent's Clinic Foundation
Country [1] 305681 0
Australia
Funding source category [2] 307217 0
Charities/Societies/Foundations
Name [2] 307217 0
St Vincent's Curran Foundation
Country [2] 307217 0
Australia
Funding source category [3] 307218 0
University
Name [3] 307218 0
UNSW Research COVID-19: Rapid Response Research Fund Projects grant
Country [3] 307218 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Health Network
Address
390 Victoria Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 306098 0
None
Name [1] 306098 0
Address [1] 306098 0
Country [1] 306098 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305961 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 305961 0
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 305961 0
Australia
Date submitted for ethics approval [1] 305961 0
23/04/2020
Approval date [1] 305961 0
27/04/2020
Ethics approval number [1] 305961 0
2020/ETH00964

Summary
Brief summary
The purpose of this observational study is to evaluate the effects of COVID-19 on the immune system, heart, lung, brain function and mental health of patients of St Vincent’s Hospital, Sydney. Patients will attend the hospital six times over the 12 months following their COVID-19 diagnosis to be monitored by their Doctor and to provide blood samples, collect swabs and complete questionnaires. Overall, the study will increase our knowledge to better understand how the body responds to COVID-19 and provide valuable information to improve care for people with this infection in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102222 0
A/Prof Gail Matthews
Address 102222 0
St Vincent's Hospital Sydney
390 Victoria Street
Darlinghurst NSW 2010
Country 102222 0
Australia
Phone 102222 0
+61 2 83823707
Fax 102222 0
Email 102222 0
gail.matthews@svha.org.au
Contact person for public queries
Name 102223 0
Gail Matthews
Address 102223 0
St Vincent's Hospital Sydney
390 Victoria Street
Darlinghurst NSW 2010
Country 102223 0
Australia
Phone 102223 0
+61 2 83823707
Fax 102223 0
Email 102223 0
gail.matthews@svha.org.au
Contact person for scientific queries
Name 102224 0
Gail Matthews
Address 102224 0
St Vincent's Hospital Sydney
390 Victoria Street
Darlinghurst NSW 2010
Country 102224 0
Australia
Phone 102224 0
+61 2 83823707
Fax 102224 0
Email 102224 0
gail.matthews@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data will not be made available in line with the conditions of our HREC approval and conditions of privacy management.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7904Informed consent form  gail.matthews@svha.org.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHigh titre neutralizing antibodies in response to SARS-CoV-2 infection require RBD-specific CD4 T cells that include proliferative memory cells.2022https://dx.doi.org/10.3389/fimmu.2022.1032911
N.B. These documents automatically identified may not have been verified by the study sponsor.