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Statin TReatment for COVID-19 to Optimise NeuroloGical recovERy

NCT04904536 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-04-10

No results posted yet for this study

Summary

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.

Conditions

  • Neurocognitive Impairment, Mild

Interventions

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.

OTHER

Standard Care

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

Sponsors & Collaborators

  • University of Sydney

    collaborator OTHER

  • Monash University

    collaborator OTHER

  • The Alfred

    collaborator OTHER

  • Universidad del Desarrollo

    collaborator OTHER

  • Chinese University of Hong Kong

    collaborator OTHER

  • Clinica Alemana de Santiago

    collaborator OTHER

  • The George Institute

    lead OTHER

Principal Investigators

  • Craig Anderson, MD · The George Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2025-06-30
Completion
2025-07-30

Countries

  • Australia

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04904536 on ClinicalTrials.gov