The Effect of Amantadine on Post-COVD-19 Fatigue: a Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scale (FSS)
研究概览
简要总结
This study aimed to investigate amantadine's safety and its effect on reducing post-COVID-19 fatigue.
详细描述
Background The 2019 coronavirus disease has severely affected the health of the general public. Even after recovery, this disease can cause problems, including chronic fatigue, which the patient can suffer from for years and cause permanent disability for a number of patients.
Despite the fact that fatigue due to COVID-19 has affected many patients, not many studies have been done in the field of effective treatment for this problem.
In this study, the investigators studied the effect of amantadine on the fatigue of COVID-19 patients.
Method In this clinical trial study, 83 patients were randomly included in the study from the patients referred to the internal clinic of Shohada Tajrish Hospital in Tehran, and they were initially evaluated by VAFS and FSS questionnaires. 17 patients were initially excluded due to having at least one exclusion criterion. And 66 patients were randomly divided between two groups using amantadine and the control group. The amantadine group was treated with amantadine capsules 100 mg BD for 2 weeks and after 2 weeks again for both The group questionnaire was completed, and the data was analyzed by SPSS software version 26.
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of COVID-19
- •clinical evidence of fatigue despite the passage of 30 to 60 days from the onset --of the symptoms of COVID-19
- •willingness and informed consent to participate in the study
排除标准
- •the recurrence of COVID-19 in the form of re-infection
- •history of psychiatric diseases
- •psychotic disorders (in the form of hallucinations and delusions)
- •anxiety disorders and major depression
- •substance abuse in the last four months
- •taking antidepressants during the last six weeks
- •corticosteroids consumption during the last six weeks
- •taking psychostimulant drugs
- •an unstable medical condition
- •cognitive disorders and confusion
- •withdrawal from participating in the study
- •history of rheumatological disease
- •getting cancer and malignancy
- •advanced chronic diseases (heart, liver, kidney, etc.)
- •edema of organs
- •hypertension (untreated)
- •hypogonadism (untreated)
- •hypothyroidism (untreated)
- •anemia (untreated)
- •pregnancy and breastfeeding
- •nausea and vomiting when starting to take Amantadine
- •convulsions
- •post-COVID-19 encephalopathy
研究组 & 干预措施
amantadine
The group that was treated with amantadine
干预措施: Amantadine (Drug)
结局指标
主要结局
Fatigue Severity Scale (FSS)
时间窗: 2 weaks
Comparison of fatigue scale score change before and after treatment with amantadine using FSS Minimum 1 Maximum 7 Higher score means greater fatique severity
Visual Analog Fatigue Scale (VAFS)
时间窗: 2 weaks
Comparison of fatigue scale score change before and after treatment with amantadine using VAFS Minimum 0 Maximum 100 Higher score means greater fatique severity
次要结局
未报告次要终点
研究者
Ali Amini Harandi
Assistant Professor
Shahid Beheshti University of Medical Sciences