Official Title
Feasibility Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid: A Pilot Randomized Control Trial
Brief Summary

Purpose: To decrease symptom burden, improve cognitive function, improve endurance, anddecrease 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 thispopulation, the findings of this study will be used towards a subsequent randomizedcontrol trial.

Detailed Description

This study is a prospective, open-label, single-blind, randomized control study. Study
duration is approximately 6 weeks starting at the baseline visit. We will recruit 30
participants (15 per arm) for this pilot study.

Recruiting
Long Covid
Post-acute COVID-19 Syndrome

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.

Eligibility Criteria

Inclusion Criteria:

- Age 20-65

- 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:

- Known hypersensitivity to amantadine

- 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

Eligibility Gender
All
Eligibility Age
Minimum: 20 Years ~ Maximum: 65 Years
Countries
United States
Locations

UT Southwestern Medical Center
Dallas, Texas, United States

Investigator: Brittany Wright

Contacts

Brittany Wright, PhD
469-892-8637
brittany.wright@utsouthwestern.edu

Amy Mathews, M.D., Principal Investigator
UT Southwestern Medical Center

University of Texas Southwestern Medical Center
NCT Number
MeSH Terms
Post-Acute COVID-19 Syndrome
Cognitive Dysfunction
Amantadine