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NCT06234462 | RECRUITING | Long COVID

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

University of Texas Southwestern Medical Center

Information provided by (Responsible Party):

Amy Mathews

Brief Summary:

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.

Condition or disease

Long COVID

Post-Acute COVID-19 Syndrome

Intervention/treatment

Amantadine

Physical, Occupational, Speech Therapy

Provider Counseling

Medications for symptoms management

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Feasibility Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid: A Pilot Randomized Control Trial
Actual Study Start Date : 2024-12-13
Estimated Primary Completion Date : 2025-05-01
Estimated Study Completion Date : 2025-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 20 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid

Location Details

NCT06234462

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How to Participate

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Locations

RECRUITING

United States, Texas

UT Southwestern Medical Center

dallas, Texas, United States, 75390