tetano
Editor, Senior Moderator
BMJ Open
. 2025 Apr 14;15(4):e089382.
doi: 10.1136/bmjopen-2024-089382. 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
Carlos Delfino[SUP] 1 [/SUP], Cheryl Carcel[SUP] 2 [/SUP], Xiaolei Lin[SUP] 3 [/SUP], Paula Muñoz-Venturelli[SUP] 1 2 [/SUP], Sharon L Naismith[SUP] 4 [/SUP], Mark Woodward[SUP] 2 5 [/SUP], Ruth Peters[SUP] 2 [/SUP], Nirupama Wijesuriya[SUP] 2 [/SUP], Meng Law[SUP] 6 [/SUP], Ian H Harding[SUP] 6 [/SUP], Xia Wang[SUP] 2 [/SUP], Julian Elliott[SUP] 7 [/SUP], Karin Leder[SUP] 7 [/SUP], Owen Hutchings[SUP] 8 [/SUP], Ximena Stecher[SUP] 9 [/SUP], Sophia Zoungas[SUP] 7 [/SUP], Craig S Anderson[SUP] 10 8 11 [/SUP]
Affiliations
Introduction: Increasing awareness of the high frequency, wide spectrum and disabling nature of symptoms that can persist following COVID-19 infection has prompted the investigation of management strategies. Our study aims to determine the effectiveness of atorvastatin on cognitive function, physical activity, mood, health-related quality of life and features of neurovascular impairment and neuroinflammation in adults with ongoing neurological symptoms after COVID-19 infection.
Methods and analysis: The STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy study is an ongoing international, investigator-initiated and conducted, multicentre, prospective, randomised, open label, blinded endpoint trial with fixed time points for outcome assessments. A total of 410 participants with long covid neurological symptoms were planned to be randomly assigned to either the intervention group to receive 40 mg atorvastatin for 12 months or to a control group of no treatment, on top of usual care.
Ethics and dissemination: This study protocol was designed, implemented and reported, in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice, the National Health and Medical Research Council of Australia, the National Statement on Ethical Conduct in Human Research and with the ethical principles laid down in the World Medical Association Declaration of Helsinki. Central ethics committee approval was obtained from Sydney Local Health District Royal Prince Alfred Hospital Ethics (No: X21-0113 and 2021/ETH00777 10) in Australia. Site-specific ethics committee approvals were obtained elsewhere before any local study activities. All participants provided written informed consent.
Trial registration number: The study protocol is registered at Clinicaltrials.gov (NCT04904536).
Keywords: COVID-19; Clinical Protocols; Post-Acute COVID-19 Syndrome; Protocols & guidelines.
. 2025 Apr 14;15(4):e089382.
doi: 10.1136/bmjopen-2024-089382. 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
Carlos Delfino[SUP] 1 [/SUP], Cheryl Carcel[SUP] 2 [/SUP], Xiaolei Lin[SUP] 3 [/SUP], Paula Muñoz-Venturelli[SUP] 1 2 [/SUP], Sharon L Naismith[SUP] 4 [/SUP], Mark Woodward[SUP] 2 5 [/SUP], Ruth Peters[SUP] 2 [/SUP], Nirupama Wijesuriya[SUP] 2 [/SUP], Meng Law[SUP] 6 [/SUP], Ian H Harding[SUP] 6 [/SUP], Xia Wang[SUP] 2 [/SUP], Julian Elliott[SUP] 7 [/SUP], Karin Leder[SUP] 7 [/SUP], Owen Hutchings[SUP] 8 [/SUP], Ximena Stecher[SUP] 9 [/SUP], Sophia Zoungas[SUP] 7 [/SUP], Craig S Anderson[SUP] 10 8 11 [/SUP]
Affiliations
- PMID: 40228860
- DOI: 10.1136/bmjopen-2024-089382
Introduction: Increasing awareness of the high frequency, wide spectrum and disabling nature of symptoms that can persist following COVID-19 infection has prompted the investigation of management strategies. Our study aims to determine the effectiveness of atorvastatin on cognitive function, physical activity, mood, health-related quality of life and features of neurovascular impairment and neuroinflammation in adults with ongoing neurological symptoms after COVID-19 infection.
Methods and analysis: The STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy study is an ongoing international, investigator-initiated and conducted, multicentre, prospective, randomised, open label, blinded endpoint trial with fixed time points for outcome assessments. A total of 410 participants with long covid neurological symptoms were planned to be randomly assigned to either the intervention group to receive 40 mg atorvastatin for 12 months or to a control group of no treatment, on top of usual care.
Ethics and dissemination: This study protocol was designed, implemented and reported, in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice, the National Health and Medical Research Council of Australia, the National Statement on Ethical Conduct in Human Research and with the ethical principles laid down in the World Medical Association Declaration of Helsinki. Central ethics committee approval was obtained from Sydney Local Health District Royal Prince Alfred Hospital Ethics (No: X21-0113 and 2021/ETH00777 10) in Australia. Site-specific ethics committee approvals were obtained elsewhere before any local study activities. All participants provided written informed consent.
Trial registration number: The study protocol is registered at Clinicaltrials.gov (NCT04904536).
Keywords: COVID-19; Clinical Protocols; Post-Acute COVID-19 Syndrome; Protocols & guidelines.