A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid
NCT ID: NCT06234462
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2025-06-30
2025-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Standard of Care
Participants in this arm will receive current standard of care for PASC symptoms which may include: PT, OT, SLP, provider counseling, and/or pharmacologic interventions for targeted symptom management.
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.
Provider Counseling
Clinic providers will provide counseling/education on Long-COVID.
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.
Standard of Care + Amantadine
Participants in this arm will review standard of care and amantadine.
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
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.
Provider Counseling
Clinic providers will provide counseling/education on Long-COVID.
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.
Interventions
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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
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.
Provider Counseling
Clinic providers will provide counseling/education on Long-COVID.
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.
Eligibility Criteria
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Inclusion Criteria
* Can provide informed consent
* Confirmed COVID+ test (either rapid antigen or PCR) between 8 weeks and one year prior to initial visit.
* Able to consent in English
* Endorse symptoms during their initial evaluation and history with the provider that began around the time of the acute COVID19 infection (subjective) including cognitive changes such as cognitive fatigue, brain fog, memory issues,attention issues AND have symptoms in at least 1 out of the 2 following symptom categories:
* Category 1: Decreased endurance, physical fatigue, weakness
* Category 2: Depression, anxiety
Exclusion Criteria
* Clinically significant psychiatric, neurologic, renal, hepatic, opthalmologic, cardiac impairment in the opinion of the investigators, including but not limited to:
* Psychiatric:
* Acute or chronic unstable Axis I psychiatric illness
* History of psychosis
* Severe depression Patient Health Questionnaire-9 (PHQ-9) score \>= 20
* Suicidality
* Neurologic:
* Epilepsy
* Cognitive dysfunction predating COVID infection
* History of delirium
* Neurologic conditions with agitation or confusion
20 Years
65 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Amy Mathews
Assistant Professor
Principal Investigators
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Amy Mathews, M.D.
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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STU-2023-0234
Identifier Type: -
Identifier Source: org_study_id
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