COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04904536

Craig Anderson, MD

canderson@georgeinstitute.org.au

2021-05-27

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Long covid

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

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

2

The George Institute

18

100

Australia

Patients recovered from covid

N/A

400

Neurological Recovery

None

Phase 3

[{"arm_notes": "", "treatment_id": 137, "treatment_name": "Atorvastatin", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]