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Statin TReatment for COVID-19 to Optimise NeuroloGical recovERy

PHASE3RECRUITING

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.

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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.

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Eligibility criteria

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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 <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

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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

Image related to Neurocognitive Impairment, Mild

Condition: Neurocognitive Impairment, Mild
DRUG: Atorvastatin and other drugs
Sydney, New South Wales, Australia
Sponsor: The George Institute

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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 6-monthly supplies of atorvastatin 40mg on top of standard care for a period of 12 months.	DRUG: Atorvastatin 40mg atorvastatin + standard care daily for 12 months.Atorvastatin 40mg has TGA approval for general marketing for the treatment of hypercholesterolaemia and cardiovascular prevention under a number of manufacturer names.The study medication selected will be the atorvastatin 40mg (Apotex) which is scored, and allows down-titration to 20mg should a participant develop symptoms.The study medication will be packaged, labelled and dispensed directly to particpants by the Syntro Health pharmacy in Australia. A comparable atorvastatin 40mg is being sourced in Chile, and will be dispensed from the pharmacy of the Clínica Alemana de Santiago. Similarly, a comparable atorvastatin 40mg is being sourced in Hong Kong, and will be dispensed from the site's pharmacy.
ACTIVE_COMPARATOR: Standard Care Arm Standard care for a period of 12 months.	OTHER: Standard Care Standard care for neurological symptoms as a result of COVID-19 infection.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Study Medication Arm

6-monthly supplies of atorvastatin 40mg on top of standard care for a period of 12 months.

DRUG: Atorvastatin

40mg atorvastatin + standard care daily for 12 months.Atorvastatin 40mg has TGA approval for general marketing for the treatment of hypercholesterolaemia and cardiovascular prevention under a number of manufacturer names.The study medication selected will be the atorvastatin 40mg (Apotex) which is scored, and allows down-titration to 20mg should a participant develop symptoms.The study medication will be packaged, labelled and dispensed directly to particpants by the Syntro Health pharmacy in Australia. A comparable atorvastatin 40mg is being sourced in Chile, and will be dispensed from the pharmacy of the Clínica Alemana de Santiago. Similarly, a comparable atorvastatin 40mg is being sourced in Hong Kong, and will be dispensed from the site's pharmacy.

ACTIVE_COMPARATOR: Standard Care Arm

Standard care for a period of 12 months.

OTHER: Standard Care

Standard care for neurological symptoms as a result of COVID-19 infection.

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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References

Clinical Trials Gov: Statin TReatment for COVID-19 to Optimise NeuroloGical recovERy