A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid

University of Texas Southwestern Medical Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Long COVID Post-Acute COVID-19 Syndrome

Interventions

AmantadineDRUG

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 TherapyOTHER

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 CounselingOTHER

Clinic providers will provide counseling/education on Long-COVID.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States