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Statin TReatment for COVID-19 to Optimise NeuroloGical recovERy
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.
Study details:
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 report ongoing alteration of their memory, thinking, concentration or mood after COVID-19 diagnosis, this pragmatic clinical trial aims to determine the effects of standard-dose atorvastatin on improving neurological outcomes with sensitive measures of cognitive function and brain MRI. Outcome measures include; Primary - processing speed, assessed on the oral Symbol Digit Modalities Test (SDMT). Key Secondary - white matter free water measured on diffusion MRI brain imaging.
Other - other components of cognitive function; other health assessments; other MRI markers of cerebral white matter integrity, iron load, cerebral perfusion, and glutathione for oxidative stress; cost-effectiveness compared to standard care. The study sites are established at centralised research clinics located at: The Brain and Mind Centre of the University of Sydney; Alfred Medical Centre linked to Monash University, a research clinic associated with Clínica Alemana Universidad del Desarrollo, Santiago, Chile, and a research clinic associated with The Chinese University of Hong Kong. Additional sites may be set up as required.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-03-10
Primary completion: 2024-12-01
Study completion finish: 2024-12-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT04904536
Intervention or treatment
DRUG: Atorvastatin
OTHER: Standard Care
Conditions
- • Neurocognitive Impairment, Mild
Find a site
Closest Location:
The George Institute for Global Health
Research sites nearby
Select from list below to view details:
The George Institute for Global Health
Sydney, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Study Medication Arm
| DRUG: Atorvastatin
|
ACTIVE_COMPARATOR: Standard Care Arm
| OTHER: Standard Care
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Neurological Recovery | Processing speed, assessed on the oral Symbol Digit Modalities Test (SDMT) | 12 months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Brain Imaging | White matter free water measured on diffusion MRI brain imaging | 12 months |
Frequently Asked Questions
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