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challenges with recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | 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. |
|
| Standard of Care + Amantadine | Experimental | Participants in this arm will review standard of care and amantadine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amantadine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measures of cognitive functioning | Cognitive Subscale of Modified Fatigue Impact Scale (MFIS) | 4 weeks |
| Measures of cognitive functioning | Self-reported percent back to normal | 4 weeks |
| Measures of cognitive functioning | FAS Test | 4 weeks |
| Measures of cognitive functioning | Trails A & B | 4 weeks |
| Measures of cognitive functioning | Digit Vigilance Test | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of endurance and strength | 6 Minute Walk Test (6MWT) | 4 weeks |
| Measures of endurance and strength | 30 second sit-to-stand | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Mathews, M.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D000547 | Amantadine |
| D012149 | Restraint, Physical |
| D013070 | Speech Therapy |
| D004304 | Dosage Forms |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Physical, Occupational, Speech Therapy | Other | 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 | Other | Clinic providers will provide counseling/education on Long-COVID. |
|
| Medications for symptoms management | Other | 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. |
|
| Measures of endurance and strength | grip strength grip strength | 4 weeks |
| Measures of endurance and strength | Physical Function subsection of PROMIS-29 | 4 weeks |
| Measures of fatigue | Physical Subscale of the Modified Fatigue Impact Scale (MFIS), and fatigue subsection of PROMIS-29. | 4 weeks |
| Measures of anxiety and depression | Patient Health Questionnaire-9 (PHQ-9) | 4-6 weeks |
| Measures of anxiety and depression | Generalized Anxiety DIsorder-7 (GAD-7) questionnaires | 4-6 weeks |
| Measures of anxiety and depression | anxiety and depression sections of the PROMIS-29 | 4-6 weeks |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |