Clinical trial · Interventional
Statin TReatment for COVID-19 to Optimise NeuroloGical recovERy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurocognitive Impairment, Mild | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
| Standard Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study Medication Arm
- description
- 6-monthly supplies of atorvastatin 40mg on top of standard care for a period of 12 months.
- interventionNames
- Drug: Atorvastatin
- type
- ACTIVE_COMPARATOR
- label
- Standard Care Arm
- description
- Standard care for a period of 12 months.
- interventionNames
- Other: Standard Care
Primary outcomes (1)
- measure
- Neurological Recovery
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDelfino C, Carcel C, Lin X, Munoz-Venturelli P, Naismith SL, Woodward M, Peters R, Wijesuriya N, Law M, Harding IH, Wang X, Elliott J, Leder K, Hutchings O, Stecher X, Zoungas S, Anderson CS. STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy (STRONGER): study protocol for a randomised, open label clinical trial in patients with persistent neurological symptoms after COVID-19 infection. BMJ Open. 2025 Apr 14;15(4):e089382. doi: 10.1136/bmjopen-2024-089382. PMID 40228860