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

Long COVID Clinical Trial

Official title:

Feasibility Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid: A Pilot Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06234462
• Other study ID #: STU-2023-0234
• Status: Recruiting
• Phase: Phase 2
• Start date: July 13, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Brittany Wright, PhD
• Phone: 469-892-8637
• Email: brittany.wright[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Long COVID

Intervention

Drug:
• Amantadine
Participants that have been randomized to the study group will be instructed to begin taking amantadine on the day after this study visit. They will self-administer amantadine 100 mg twice daily (morning and noon) for four weeks

Other:
• Physical, Occupational, Speech Therapy
Physical Therapy (PT) and Occupational Therapy (OT) train patients on breathing exercises and gradual reconditioning. Patients are referred to speech therapy (SLP) for cognitive remediation and metacognitive strategies.
• Provider Counseling
Clinic providers will provide counseling/education on Long-COVID.
• Medications for symptoms management
Clinic providers may recommend targeted pharmacologic management for symptoms the patient is experience. As an example, if a patient reports a headache the provider may recommend over-the-counter or prescription medications to target this particular symptom.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures of cognitive functioning	Repeatable Battery for the Assessment of Neuropsychological Status (R BANS) Self-reported percent back to normal, FAS, Trails A&B, and Digit; Vigilance Test (DVT)	4 weeks
Primary	Measures of cognitive functioning	Cognitive Subscale of Modified Fatigue Impact Scale (MFIS)	4 weeks
Primary	Measures of cognitive functioning	Self-reported percent back to normal	4 weeks
Primary	Measures of cognitive functioning	FAS Test	4 weeks
Primary	Measures of cognitive functioning	Trails A & B	4 weeks
Primary	Measures of cognitive functioning	Digit Vigilance Test	4 weeks
Secondary	Measures of endurance and strength	6 Minute Walk Test (6MWT)	4 weeks
Secondary	Measures of endurance and strength	30 second sit-to-stand	4 weeks
Secondary	Measures of endurance and strength	grip strength; grip strength	4 weeks
Secondary	Measures of endurance and strength	Physical Function subsection of PROMIS-29	4 weeks
Secondary	Measures of fatigue	Physical Subscale of the Modified Fatigue Impact Scale; (MFIS), and fatigue subsection of PROMIS-29.	4 weeks
Secondary	Measures of anxiety and depression	Patient Health Questionnaire-9 (PHQ-9)	4-6 weeks
Secondary	Measures of anxiety and depression	Generalized Anxiety DIsorder-7 (GAD-7) questionnaires	4-6 weeks
Secondary	Measures of anxiety and depression	anxiety and depression sections of the PROMIS-29	4-6 weeks