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

Recruiting
20 - 65 years of age
Both
Phase 2

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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.

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.

Eligibility

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 details

Long COVID, Post-Acute COVID-19 Syndrome

NCT06234462

University of Texas Southwestern Medical Center

2 April 2025

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Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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