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A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid
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:
🦠 Long COVID 🦠 Post-Acute COVID-19 Syndrome
🗓️ Study Start (Actual) 13 July 2024
🗓️ Primary Completion (Estimated) 1 May 2025
✅ Study Completion (Estimated) 1 June 2025
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Dallas, Texas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 20 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 January 2024
  • First Submitted that Met QC Criteria 29 January 2024
  • First Posted 31 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 May 2024
  • Last Update Posted 3 June 2024
  • Last Verified May 2024
I'm interested ...!!