Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04904536




Registration number
NCT04904536
Ethics application status
Date submitted
21/05/2021
Date registered
27/05/2021
Date last updated
28/11/2023

Titles & IDs
Public title
Statin TReatment for COVID-19 to Optimise NeuroloGical recovERy
Scientific title
An International, Investigator Initiated and Conducted, Pragmatic Clinical Trial to Determine Whether 40mg Atorvastatin Daily Can Improve Neurocognitive Function in Adults With Long COVID Neurological Symptoms
Secondary ID [1] 0 0
X21-0113
Universal Trial Number (UTN)
Trial acronym
STRONGER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurocognitive Impairment, Mild 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atorvastatin
Other interventions - Standard Care

Experimental: Study Medication Arm - 6-monthly supplies of atorvastatin 40mg on top of standard care for a period of 12 months.

Active comparator: Standard Care Arm - Standard care for a period of 12 months.


Treatment: Drugs: Atorvastatin
40mg atorvastatin + standard care daily for 12 months.Atorvastatin 40mg has TGA approval for general marketing for the treatment of hypercholesterolaemia and cardiovascular prevention under a number of manufacturer names.The study medication selected will be the atorvastatin 40mg (Apotex) which is scored, and allows down-titration to 20mg should a participant develop symptoms.The study medication will be packaged, labelled and dispensed directly to particpants by the Syntro Health pharmacy in Australia. A comparable atorvastatin 40mg is being sourced in Chile, and will be dispensed from the pharmacy of the Clínica Alemana de Santiago. Similarly, a comparable atorvastatin 40mg is being sourced in Hong Kong, and will be dispensed from the site's pharmacy.

Other interventions: Standard Care
Standard care for neurological symptoms as a result of COVID-19 infection.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Neurological Recovery
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Brain Imaging
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
* Age =18 years
* History of COVID-19 that is confirmed by a positive polymerase-chain-reaction (PCR) test,rapid antigen test (RAT) or as per the state guidelines for COVID-19 diagnosis at the time of screening
* Any ongoing neurological symptoms as a result of COVID-19 (e.g. problems with memory, concentration, sleep disturbance and fatigue) that are identified through administration of the checklist of symptoms on the Somatic and Psychological Health Report (SPHERE) questionnaire, or reported loss of smell (anosmia)
* Able to fully participate in all procedures, including cognitive assessments
* Able and willing to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Evidence of dementia and/or significant cognitive impairment on screening (i.e: Blind Montreal Cognitive Assessment [MoCA] score <19/22 in conjunction with clinical assessment)
* Severe co-morbid medical or psychiatric condition that prevents participation
* History of traumatic brain injury with loss of consciousness (>30 mins) within the last 2 years
* Ongoing long-term use for a clear indication (e.g. secondary cardiovascular prevention in high-risk individuals) or any contraindication (e.g. previous adverse reaction) of statin use
* Evidence of severe or significant liver disease, defined as any of the following: acute viral hepatitis; chronic active hepatitis; chronic active hepatitis; cirrhosis; or elevated biochemical function markers i.e. ALT or AST >3x the ULN or eGFR <30mL/min/1.73m2
* Creatine kinase (CK) levels > 2x upper limit of normal (ULN)
* Female of child-bearing potential that is unable or unwilling to use reliable method of contraception, breastfeeding, or planning a pregnancy
* For a sub-group of participants undergoing MRI - any contraindication to MRI due to metallic body parts or claustrophobia
* Medical history of a disorder that might, in the opinion of the attending clinician, put the participant at significant risk if they were to participate in the trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The George Institute for Global Health - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The Alfred
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Universidad del Desarrollo
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Chinese University of Hong Kong
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Clinica Alemana de Santiago
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Craig Anderson, MD
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Craig Anderson, MD
Address 0 0
Country 0 0
Phone 0 0
+61 2 8052 4521
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04904536