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Clinical Trials in Australia / NCT04904536
Active, not recruiting Phase 3

Statin TReatment for COVID-19 to Optimise NeuroloGical recovERy

NCT04904536 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2022-03-10
Last updated
2025-04-10

Condition(s) studied

Neurocognitive Impairment, Mild

Investigational drug(s) / intervention(s)

Atorvastatin →Standard Care

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.

Standard Care: Standard care for neurological symptoms as a result of COVID-19 infection.

Study summary

STRONGER is 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. The objective is to determine effectiveness of treatment with 40mg atorvastatin over 12 months on attenuating cognitive decline and neuroinflammatory biomarkers in adults with long COVID neurological symptoms. The study design is a prospective, randomised, open-label, blinded endpoint (PROBE) study of atorvastatin 40mg on top of standard care, in patients with long COVID neurological symptoms.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The George Institute for Global Health Sydney New South Wales

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04904536 on ClinicalTrials.gov ↗ ← All trials in Australia