ANZCTR - Registration

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 information for consumers

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

ADAPT

Linked study record

Health condition

Health condition(s) or problem(s) studied:

COVID-19

Condition category

Condition code

Infection

Other infectious diseases

Respiratory

Other respiratory disorders / diseases

Public Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Primary outcome is the evolution of an immunological response to COVID-19 measured by COVID-19 antibody formation.

Timepoint [1]

1, 4 and 12 months post COVID-19 diagnosis

Secondary outcome [1]

The immunological response to COVID-19 measured by COVID-19 antibody formation.

Timepoint [1]

1,2 and 32 weeks post COVID-19 diagnosis

Secondary outcome [2]

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]

4, 16 and 48 weeks post COVID-19 diagnosis

Secondary outcome [3]

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]

2, 4, 16 and 48 weeks post COVID-19 diagnosis

Secondary outcome [4]

To evaluate the impact of COVID-19 on neurocognitive function using the self administered version of the Cogstate computerised battery of tests.

Timepoint [4]

4, 16 and 48 weeks post COVID-19 diagnosis

Secondary outcome [5]

Characterise the quality of sleep in adults diagnosed with COVID-19 via Sleep Study (polysomnography).

Timepoint [5]

16 weeks post COVID-19 diagnosis.

Secondary outcome [6]

Change in lung microbiome over time following COVID-19 , assessed using analysis of saliva swabs by the Microbiome Research Centre, UNSW

Timepoint [6]

1,4,16 and 48 weeks post COVID-19 diagnosis

Secondary outcome [7]

Change in gut microbiome over time following COVID-19 , assessed using analysis of stool samples by the Microbiome Research Centre, UNSW

Timepoint [7]

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?

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]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment postcode(s) [1]

2010 - Darlinghurst

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

St Vincent's Clinic Foundation

Address [1]

438 Victoria St Darlinghurst NSW 2040

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

St Vincent's Curran Foundation

Address [2]

390 Victoria St Darlinghurst NSW 2010

Country [2]

Australia

Funding source category [3]

University

Name [3]

UNSW Research COVID-19: Rapid Response Research Fund Projects grant

Address [3]

University of New South Wales High St Kensington, NSW 2052

Country [3]

Australia

Primary sponsor type

Hospital

Name

St Vincent's Health Network

Address

390 Victoria Street
Darlinghurst NSW 2010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Human Research Ethics Committee

Ethics committee address [1]

390 Victoria Street
Darlinghurst NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/04/2020

Approval date [1]

27/04/2020

Ethics approval number [1]

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

A/Prof Gail Matthews

Address

St Vincent's Hospital Sydney 390 Victoria Street Darlinghurst NSW 2010

Country

Australia

Phone

+61 2 83823707

Fax

[email protected]

Contact person for public queries

Name

Gail Matthews

Address

St Vincent's Hospital Sydney 390 Victoria Street Darlinghurst NSW 2010

Country

Australia

Phone

+61 2 83823707

Fax

[email protected]

Contact person for scientific queries

Name

Gail Matthews

Address

St Vincent's Hospital Sydney 390 Victoria Street Darlinghurst NSW 2010

Country

Australia

Phone

+61 2 83823707

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No 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?

Type	Citation	Link	Email	Other Details	Attachment
Informed consent form			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	High titre neutralizing antibodies in response to SARS-CoV-2 infection require RBD-specific CD4 T cells that include proliferative memory cells.	2022	https://dx.doi.org/10.3389/fimmu.2022.1032911

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically