Print

Purpose

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

Eligibility

Eligible Ages
Between 20 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
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.
  • 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.
Experimental
Standard of Care + Amantadine 		Participants in this arm will review standard of care and amantadine.
  • 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.

Recruiting Locations

UT Southwestern Medical Center
Dallas, Texas 75390
Contact:
Brittany Wright

More Details

NCT ID
NCT06234462
Status
Recruiting
Sponsor
University of Texas Southwestern Medical Center

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.