Effect of Low-dose Lithium Therapy on Long COVID Symptoms: a Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scale
研究概览
简要总结
This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.
详细描述
In this double-blind, placebo-controlled study, 50 patients with long COVID will be randomly assigned to either low-dose oral lithium or placebo therapy for three weeks. After the double-blind study phase, all patients will be provided with lithium therapy for two additional weeks. Study visits will occur at baseline and after the three-week double-blind study phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lithium
Lithium 10mg po qd
干预措施: Lithium (Drug)
Placebo
Placebo identically matching the lithium pills
干预措施: Placebo (Drug)
结局指标
主要结局
Fatigue Severity Scale
时间窗: Change from baseline to day 21
7-item questionnaire assessing fatigue severity. Score range 1-49 with higher values signifying worse outcome
Brain Fog Severity Scale
时间窗: Change from baseline to day 21
7-item questionnaire assessing brain fog severity. Score range 1-49 with higher values signifying worse outcome
次要结局
- Patient Global Impression of Change (PGIC)(Day 21)
- Well-Being Scale(Change from baseline to day 21)
- Short Form-12 Health Survey (1-week Modification)(Change from baseline to day 21)
- Desire to Continue Therapy(Day 21)
- Generalized Anxiety Disorder-2 Scale(Change from baseline to day 21)
- Headache and Body Pain Bother Scale(Change from baseline to day 21)
- Insomnia Severity Index(Change from baseline to day 21)
- Sense of Smell and Taste Change Scale(Day 21)
- Digit Symbol Substitution Test(Change from baseline to day 21)
- Delayed Recall Test(Change from baseline to day 21)
研究者
Thomas Guttuso
Professor of Neurology
State University of New York at Buffalo