A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid
NCT06234462 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2025-08-26
Summary
Purpose: To decrease symptom burden, improve cognitive function, improve endurance, and decrease fatigue in subjects with post-acute sequelae of COVID-19 (PASC) or "long-hauler" COVID using amantadine. If amantadine use is determined to be efficacious in this population, the findings of this study will be used towards a subsequent randomized control trial.
Conditions
- Long COVID
- Post-Acute COVID-19 Syndrome
Interventions
- DRUG
-
Amantadine
Participants that have been randomized to the study group will be instructed to begin taking amantadine on the day after this study visit. They will self-administer amantadine 100 mg twice daily (morning and noon) for four weeks
- OTHER
-
Physical, Occupational, Speech Therapy
Physical Therapy (PT) and Occupational Therapy (OT) train patients on breathing exercises and gradual reconditioning. Patients are referred to speech therapy (SLP) for cognitive remediation and metacognitive strategies.
- OTHER
-
Provider Counseling
Clinic providers will provide counseling/education on Long-COVID.
- OTHER
-
Medications for symptoms management
Clinic providers may recommend targeted pharmacologic management for symptoms the patient is experience. As an example, if a patient reports a headache the provider may recommend over-the-counter or prescription medications to target this particular symptom.
Sponsors & Collaborators
-
University of Texas Southwestern Medical Center
lead OTHER
Principal Investigators
-
Amy Mathews, M.D. · UT Southwestern Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-30
- Primary Completion
- 2025-09-01
- Completion
- 2025-10-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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