Long COVID, Post-Acute COVID-19 Syndrome
Conditions
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.
Interventions
DRUGAmantadine
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
OTHERPhysical, 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.
OTHERProvider Counseling
Clinic providers will provide counseling/education on Long-COVID.
OTHERMedications 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.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measures of cognitive functioning | 4 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measures of endurance and strength | 4 weeks | 6 Minute Walk Test (6MWT) |
| Measures of fatigue | 4 weeks | Physical Subscale of the Modified Fatigue Impact Scale (MFIS), and fatigue subsection of PROMIS-29. |
| Measures of anxiety and depression | 4-6 weeks | Patient Health Questionnaire-9 (PHQ-9) |
Countries
United States
Outcome results
None listed