NCT06108297已完成1 期
Effect of Low-dose Lithium Therapy on Long COVID Symptoms: an Open-label, Dose-finding Study.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Fatigue Severity Scale (FSS)
研究概览
简要总结
This open-label study will assess if lithium dosages of 30-45mg/day are associated with greater symptomatic benefit than dosages of 10-15mg/day previously assessed among 50 patients with long COVID.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Enrolled from November 2022-July 2023 in lithium long COVID clinical trial at UB.
- •Reports bothersome fatigue and/or brain fog while not taking lithium or, reports satisfactory benefit to these symptoms while taking lithium.
- •Fatigue Severity Scale (FSS) score ≥28 or Brain Fog Severity Scale (BFSS) score ≥28 at baseline or; FSS <28, BFSS <28 and PGIC at Visit 1 of "much improved" or "very much improved" while taking lithium.
- •Did not "respond" to placebo therapy, based on the responder analyses outlined in the Preliminary data section above, defined as a ≥18-point reduction FSS or ≥15-point reduction in BFSS from baseline to the end-of-double-blind study phase while receiving placebo therapy.
排除标准
- •Fever or signs of acute infection in last 4 weeks.
- •COVID vaccine administered within 4 weeks. No change in any psychoactive or steroid medications for ≥30 days.
- •Plan to change a psychoactive, steroid or diuretic medication in next 5 weeks.
- •History of heart attack or stroke within the previous year.
- •Active medical, psychiatric or social problem that would interfere with completing the study procedures in the opinion of the investigator.
- •Daily NSAID use.
- •Pregnant or nursing or planning to get pregnant over the next 11 weeks.
结局指标
主要结局
Fatigue Severity Scale (FSS)
时间窗: Baseline to end-of-titration (up to 11 weeks)
7-item scale. Score range 1-49 with higher values signifying worse outcome
Brain Fog Severity Scale (BFSS)
时间窗: Baseline to end-of-titration (up to 11 weeks)
7-item scale. Score range 1-49 with higher values signifying worse outcome
次要结局
- Perceived Deficits Questionnaire, 5-Item Version(Baseline to end-of-titration (up to 11 weeks))
- Insomnia Severity Index(Baseline to end-of-titration (up to 11 weeks))
- Short Form-12 Health Survey(Baseline to end-of-titration (up to 11 weeks))
- Modified Fatigue Impact Scale(Baseline to end-of-titration (up to 11 weeks))
- Well Being Scale(Baseline to end-of-titration (up to 11 weeks))
- FSS scores in those with FSS score ≥28 at baseline(Baseline to end-of-titration (up to 11 weeks))
- BFSS scores in those with FSS score ≥28 at baseline(Baseline to end-of-titration (up to 11 weeks))
- Headache and Body Pain Bother Scale(Baseline to end-of-titration (up to 11 weeks))
- Patient Global Impression of Change(End-of-titration (up to 11 weeks))
- Beck Depression Inventory-II(Baseline to end-of-titration (up to 11 weeks))
- Generalized Anxiety Disorder Scale-2(Baseline to end-of-titration (up to 11 weeks))
- Desire to Continue Therapy Scale(End-of-titration (up to 11 weeks))
研究者
Thomas Guttuso
Professor of Neurology
State University of New York at Buffalo
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Effect of Lithium Therapy on Long COVID SymptomsLong COVIDNCT05618587State University of New York at Buffalo52
已完成
1 期
Effects of Lithium Therapy on Blood-based Therapeutic Targets in Parkinson's Disease.Parkinson DiseaseNCT04273932State University of New York at Buffalo19
Enrolling By Invitation
1 期
Lithium for Parkinson's: an Extension TrialParkinson DiseaseNCT06592014State University of New York at Buffalo35
已完成
不适用
A clinical study to evaluate the effects of the Linablue tablet on skin functioJPRN-UMIN000035205Soiken Inc.96
已完成
4 期
Adult Bipolar ManiaAcute ManiaNCT00931723AstraZeneca356