Feasibility Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid: A Pilot Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Measures of cognitive functioning
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
- •Cognitive dysfunction predating COVID infection
- •History of delirium
- •Neurologic conditions with agitation or confusion
研究组 & 干预措施
Standard of Care
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.
干预措施: Physical, Occupational, Speech Therapy (Other)
Standard of Care
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.
干预措施: Provider Counseling (Other)
Standard of Care
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.
干预措施: Medications for symptoms management (Other)
Standard of Care + Amantadine
Participants in this arm will review standard of care and amantadine.
干预措施: Amantadine (Drug)
Standard of Care + Amantadine
Participants in this arm will review standard of care and amantadine.
干预措施: Physical, Occupational, Speech Therapy (Other)
Standard of Care + Amantadine
Participants in this arm will review standard of care and amantadine.
干预措施: Provider Counseling (Other)
Standard of Care + Amantadine
Participants in this arm will review standard of care and amantadine.
干预措施: Medications for symptoms management (Other)
结局指标
主要结局
Measures of cognitive functioning
时间窗: 4 weeks
Digit Vigilance Test
次要结局
- Measures of fatigue(4 weeks)
- Measures of anxiety and depression(4-6 weeks)
- Measures of endurance and strength(4 weeks)
研究者
Amy Mathews
Assistant Professor
University of Texas Southwestern Medical Center