Clinical trial NCT06234462: A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid
Official title: Feasibility Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid: A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Long COVID
Post-Acute COVID-19 Syndrome
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Measures of cognitive functioning
timeFrame: 4 weeks
measure: Measures of cognitive functioning
timeFrame: 4 weeks
measure: Measures of cognitive functioning
timeFrame: 4 weeks
measure: Measures of cognitive functioning
timeFrame: 4 weeks
measure: Measures of cognitive functioning
timeFrame: 4 weeks
measure: Measures of cognitive functioning
timeFrame: 4 weeks
Secondary outcomes:
measure: Measures of endurance and strength
timeFrame: 4 weeks
measure: Measures of endurance and strength
timeFrame: 4 weeks
measure: Measures of endurance and strength
timeFrame: 4 weeks
measure: Measures of endurance and strength
timeFrame: 4 weeks
measure: Measures of fatigue
timeFrame: 4 weeks
measure: Measures of anxiety and depression
timeFrame: 4-6 weeks
measure: Measures of anxiety and depression
timeFrame: 4-6 weeks
measure: Measures of anxiety and depression
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Amy Mathews, M.D.
role: PRINCIPAL_INVESTIGATOR
References: