| Title: |
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 |
| Authors: |
Delfino, C; Carcel, C; Lin, X; Muñoz-Venturelli, P; Naismith, SL; Woodward, M; Peters, R; Wijesuriya, N; Law, M; Harding, IH; Wang, X; Elliott, J; Leder, K; Hutchings, O; Stecher, X; Zoungas, S; Anderson, CS |
| Source: |
urn:ISSN:2044-6055 ; BMJ Open, 15, 4, e089382 |
| Publisher Information: |
BMJ |
| Publication Year: |
2025 |
| Collection: |
UNSW Sydney (The University of New South Wales): UNSWorks |
| Subject Terms: |
4203 Health Services and Systems; 32 Biomedical and Clinical Sciences; 3202 Clinical Sciences; 42 Health Sciences; Clinical Research; Coronaviruses; Behavioral and Social Science; Clinical Trials and Supportive Activities; Emerging Infectious Diseases; Infectious Diseases; 3 Good Health and Well Being; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; COVID-19; Atorvastatin; COVID-19 Drug Treatment; SARS-CoV-2; Quality of Life; Prospective Studies; Randomized Controlled Trials as Topic; Male; Female; Nervous System Diseases; Adult; Middle Aged; Multicenter Studies as Topic; Cognition; Clinical Protocols; Post-Acute COVID-19 Syndrome; Protocols & guidelines |
| Description: |
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). |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
unknown |
| Relation: |
https://hdl.handle.net/1959.4/104778 |
| DOI: |
10.1136/bmjopen-2024-089382 |
| Availability: |
https://hdl.handle.net/1959.4/104778; https://unsworks.unsw.edu.au/bitstreams/146ab541-c2b9-4eae-94be-8326933d386c/download; https://doi.org/10.1136/bmjopen-2024-089382 |
| Rights: |
open access ; https://purl.org/coar/access_right/c_abf2 ; CC BY ; https://creativecommons.org/licenses/by/4.0/ ; free_to_read |
| Accession Number: |
edsbas.4984DF84 |
| Database: |
BASE |