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

The University of Texas System (UT)

Status and phase: Enrolling; Phase 2

Conditions: Post-Acute COVID-19 Syndrome; Long COVID

Treatments: Other: Physical, Occupational, Speech Therapy; Other: Provider Counseling; Other: Medications for symptoms management; Drug: Amantadine

Study type: Interventional

Funder types: Other

Identifiers

NCT06234462

STU-2023-0234

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Other: Medications for symptoms management

Other: Provider Counseling

Other: Physical, Occupational, Speech Therapy

Standard of Care + Amantadine

Experimental group

Description:

Participants in this arm will review standard of care and amantadine.

Treatment:

Drug: Amantadine

Other: Medications for symptoms management

Other: Provider Counseling

Other: Physical, Occupational, Speech Therapy