Treatment for Post Acute COVID-19 Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Tinnitus Handicap Inventory (THI)
研究概览
简要总结
Post-acute COVID-19 tinnitus has not been treated successfully. As tinnitus may be related to SARS-CoV-2 neurological manifestations. This study aims to investigate if the dopamine receptor antagonists can be used effectively treat COVID-19 induced tinnitus.
详细描述
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative viral pathogen leading to the COVID-19 pandemic. In 2022, after three successive waves of the pandemic, the majority of the human population has been exposed to the SARS-CoV-2 virus. During the two years since the pandemic ensued, multiple reports emerged of patients experiencing COVID-19 emergent symptoms lasting longer than 4 weeks since onset. Up to 15% of patients recovering from COVID-19 experience post-acute COVID-19 induced tinnitus .
To-date, post-acute COVID-19 tinnitus has not been treated successfully. As tinnitus may be related to SARS-CoV-2 neurological manifestations. This study aims to investigate if the dopamine receptor antagonist Pimozide can be used effectively treat COVID-19 induced tinnitus.
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)
盲法说明
Triple blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with subjective tinnitus post COVID-19
- •Tinnitus persists for at least 4 weeks
- •Prior history of mild or no tinnitus
- •18 years or older
- •Females of child bearing age must be on contraception
排除标准
- •Patients who participated in any interventional studies in the past 6 months
- •Patients with severe hepatic impairment on admission (alanine aminotransferase higher than fivefold the upper limit)
- •Patients taking any dopamine receptor antagonists
- •Patient having history of hypersensitivity to Pimozide
- •Patients unable to comply with the study schedule
- •Actively using cortiocosteroids
研究组 & 干预措施
Dopamine Receptor Modulator
Pimozide 1mg Oral
干预措施: Pimozide 1 MG (Drug)
Placebo
Placebo Oral
干预措施: Pimozide 1 MG (Drug)
结局指标
主要结局
Tinnitus Handicap Inventory (THI)
时间窗: 4 weeks
The Tinnitus Handicap Inventory Scale is between 0-100. And is stratified to Grades between 1-5. A higher grades means more severe handicap from tinnitus.
次要结局
未报告次要终点