Status:
ACTIVE_NOT_RECRUITING
Statin TReatment for COVID-19 to Optimise NeuroloGical recovERy
Lead Sponsor:
The George Institute
Collaborating Sponsors:
University of Sydney
Monash University
Conditions:
Neurocognitive Impairment, Mild
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Question: Does treatment with 40mg atorvastatin over 12 months attenuate cognitive decline and neuroinflammatory biomarkers in adults with long COVID neurological symptoms? Aims: In 410 adults who rep...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT04904536
Start Date
March 10 2022
End Date
July 30 2025
Last Update
April 10 2025
Active Locations (1)
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1
The George Institute for Global Health
Sydney, New South Wales, Australia, 2050