NCT04904536Active, not recruitingPhase 3
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 · Last updated 10 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 190 (actual)
- First submitted
- 21 May 2021
- Start date
- 10 Mar 2022
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- The George Institute
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT04904536
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 190
- From 10 Mar 2022 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- 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
Lab values
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The George Institute for Global Health Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.