Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000718741
Ethics application status
Approved
Date submitted
12/05/2022
Date registered
19/05/2022
Date last updated
14/02/2023
Date data sharing statement initially provided
19/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The SA Long COVID Study
Scientific title
The SA Long COVID study: A clinical registry defining the care needs for patients with Post-COVID-19 conditions in South Australia
Secondary ID [1] 307094 0
None
Universal Trial Number (UTN)
U1111-1278-1221
Trial acronym
SA-LCS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-acute sequelae SARS-CoV-2 infection (PASC) (Long COVID) 326253 0
COVID-19 326324 0
Condition category
Condition code
Public Health 323558 323558 0 0
Epidemiology
Public Health 323559 323559 0 0
Health service research
Infection 323628 323628 0 0
Other infectious diseases
Respiratory 323629 323629 0 0
Other respiratory disorders / diseases
Neurological 323630 323630 0 0
Other neurological disorders
Cardiovascular 323631 323631 0 0
Other cardiovascular diseases
Musculoskeletal 323632 323632 0 0
Other muscular and skeletal disorders
Mental Health 323633 323633 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 323634 323634 0 0
Other physical medicine / rehabilitation
Renal and Urogenital 323635 323635 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Years
Description of intervention(s) / exposure
Observational study of patients with Long COVID determining their health needs within a public hospital outpatient service. The information collected includes basic demographics, date of COVID infection, vaccination status, symptoms persisting after 12 weeks from the initial infection, medical history, social history, family history of relevant medical conditions, vitals, height and weight.
Screening questionnaires, namely the C19-YRS=COVID-19 Yorkshire Rehabilitation Scale; PCFS= Post-COVID Functional Scale; PSQI=Pittsburgh Sleep Quality Index, will be provided to participants to complete at the first clinic visit and then at weeks 13, 26, 52, 78, 104 and 156. The questionnaires will take approximately 15 minutes to complete. These can be mailed out or electronic copies provided where requested. All participants will be followed for 3 years from entry into the study. Their electronic hospital medical records will be accessed to obtain information such as specialist services utilised, investigations performed and their results, community services required and outcomes such as recovery - complete or otherwise.
Intervention code [1] 323571 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331349 0
The number of patients with persisting long COVID symptoms.
This will be determined from accessing medical records and questionnaires using the C19-YRS (COVID-19 Yorkshire Rehabilitation Scale), PCFS (Post-COVID Functional Scale), Sleep Quality using the PSQI (Pittsburgh Sleep Quality Index)
Timepoint [1] 331349 0
From entry into the study at week1 then weeks 13, 26, 52, 78, 104 and 156.
Secondary outcome [1] 409597 0
The number and type of inpatient and outpatient visits, medication dispensed, associated costs (medical records)
Timepoint [1] 409597 0
From entry into the study at week1 then weeks 13, 26, 52, 78, 104 and 156.
Secondary outcome [2] 409687 0
Quality of life measured using the C19-YRS (COVID-19 Yorkshire Rehabilitation Scale)
Timepoint [2] 409687 0
The timepoints are from entry into the study at week1 then weeks 13, 26, 52, 78, 104 and 156.
Secondary outcome [3] 409688 0
Functional performance using the PCFS (Post-COVID Functional Scale)
Timepoint [3] 409688 0
The timepoints are from entry into the study at week1 then weeks 13, 26, 52, 78, 104 and 156.
Secondary outcome [4] 409689 0
Sleep Quality using the PSQI (Pittsburgh Sleep Quality Index)
Timepoint [4] 409689 0
The timepoints are from entry into the study at week1 then weeks 13, 26, 52, 78, 104 and 156.

Eligibility
Key inclusion criteria
1. Age 18 years or older
2. SARS-CoV-2 by nucleic acid testing or rapid antigen testing
3. At least 3 months from the onset of proven COVID-19 with symptoms that have persisted for 2 months with no other alternative diagnosis. Symptoms known or suspected to be associated with Long COVID/PASC
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. Unable or unwilling to attend study visits

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Interim analysis and reporting will be done on all data from all participants at timepoints 26 weeks, 52 weeks and 104 weeks. A final analysis will be conducted at the end of the study.
General Considerations
The general analytical approach for all endpoints will be descriptive in nature.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/05/2022
Actual
1/06/2022
Date of last participant enrolment
Anticipated
20/05/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 22356 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 22357 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 24039 0
Repatriation General Hospital - Daw Park
Recruitment postcode(s) [1] 37518 0
5000 - Adelaide
Recruitment postcode(s) [2] 37519 0
5011 - Woodville
Recruitment postcode(s) [3] 39535 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 311401 0
Hospital
Name [1] 311401 0
Central Local Adelaide Health Network
Country [1] 311401 0
Australia
Primary sponsor type
Hospital
Name
Central Local Adelaide Health Network
Address
Royal Adelaide Hospital, Port Road, Adelaide SA 5000
The Queen Elizabeth Hospital, 28 Woodville Rd, Woodville South SA 5011
Country
Australia
Secondary sponsor category [1] 312790 0
None
Name [1] 312790 0
Address [1] 312790 0
Country [1] 312790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310882 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 310882 0
Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
HREC Support Officer
The Queen Elizabeth Hospital
Ground Floor, Basil Hetzel Institute
28 Woodville Road
WOODVILLE SOUTH SA 5011
Ethics committee country [1] 310882 0
Australia
Date submitted for ethics approval [1] 310882 0
06/05/2022
Approval date [1] 310882 0
25/05/2022
Ethics approval number [1] 310882 0

Summary
Brief summary
This study is looking at how COVID-19 has affected people including their fitness, health and quality of life after their initial infection. Where effects persist for 12 weeks after infection, this is known as Long COVID. Even people who had relatively mild COVID-19 at the time can experience long COVID symptoms.
Doctors are in the early stages of understanding this condition and there are a variety of different symptoms affecting many parts of the body. Symptoms can include fatigue, breathlessness, a cough that won’t go away, joint pain, muscle aches, hearing and eyesight problems, headaches, loss of smell and taste as well as problems affecting the heart, lungs, kidneys and gut. Mental health problems have also been reported including depression, anxiety and struggling to think clearly or ‘brain fog’. Clinicians will use questionnaires developed across the world for this purpose, to help gather this information and observe the treatments used. Information obtained from this study will help clinicians understand how best to identify and manage Long COVID.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119214 0
Dr Angela Molga
Address 119214 0
Department of Clinical Pharmacology
Level 8F 401 Mail Delivery Point 63
Royal Adelaide Hospital
1 Port Road, ADELAIDE, South Australia, 5000
Country 119214 0
Australia
Phone 119214 0
+61 08 70742701
Fax 119214 0
+61 08 8429 6070
Email 119214 0
angela.molga@sa.gov.au
Contact person for public queries
Name 119215 0
Dr Angela Molga
Address 119215 0
Department of Clinical Pharmacology
Level 8F 401 Mail Delivery Point 63
Royal Adelaide Hospital
1 Port Road, ADELAIDE, South Australia, 5000
Country 119215 0
Australia
Phone 119215 0
+61 08 70742701
Fax 119215 0
+61 08 8429 6070
Email 119215 0
angela.molga@sa.gov.au
Contact person for scientific queries
Name 119216 0
Dr Angela Molga
Address 119216 0
Department of Clinical Pharmacology
Level 8F 401 Mail Delivery Point 63
Royal Adelaide Hospital
1 Port Road, ADELAIDE, South Australia, 5000
Country 119216 0
Australia
Phone 119216 0
+61 08 70742701
Fax 119216 0
+61 08 8429 6070
Email 119216 0
angela.molga@sa.gov.au

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
16028Informed consent form  angela.molga@sa.gov.au
18340Ethical approval    384039-(Uploaded-13-02-2023-14-09-49)-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.