Statin TReatment for COVID-19 to Optimise NeuroloGical recovERy (NCT04904536) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Statin TReatment for COVID-19 to Optimise NeuroloGical recovERy
Australia190 participantsStarted 2022-03-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 \<30…