The Role of Glutathione Deficiency and MSIDS Variables in Long COVID-19
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Quality of Life Using SF-36 Survey
研究概览
简要总结
The purpose of this research study is to assess if glutathione, along with NAC (N-acetyl cysteine) and Alpha lipoic acid (ALA), can help reverse some of the COVID long-haul symptoms.Subjects will be randomized in to one of two groups. Depending on the group they are randomized in to, subjects will be taking either a combination of NAC, Alamax CR, and liposomal GSH or the same three nutritional supplements with a multivitamin and magnesium. Regardless of the group, subjects will be asked questions to assess their COVID symptoms, physical and mental health status. They will also be asked to take blood samples.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with positive COVID testing (AB, RT PCR) and mild-severe symptoms based on COVID symptom list
排除标准
- •History of a severe sulfa sensitivity (i.e., anaphylaxis, Stevens Johnson Syndrome), allergy to meat products and/or gelatin (alpha gal allergy) and/or a history of an allergic or adverse reaction to NAC, alpha lipoic acid and/or GSH.
研究组 & 干预措施
No Multivitamin and Magnesium
Subjects randomized into Group A will take the following amount for 28 days
- 4 capsules of NAC (600mg each) once in the morning and once in the evening
- 1 tablet (600mg) of Alamax CR once in the morning and once in the evening
- 8 capsules (250 mg each) of liposomal GSH in the morning and in the evening
干预措施: NAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH) (Drug)
Multivitamin and Magnesium
Subjects randomized into Group B will be taking a multivitamin and magnesium for 14 days. Afterwards, they will take the following for 14 days.
- 4 capsules of NAC (600mg each) once in the morning and once in the evening
- 1 tablet (600mg) of Alamax CR once in the morning and once in the evening
- 8 capsules (250 mg each) of liposomal GSH in the morning and in the evening
干预措施: NAC (N-acetyl cysteine), Alpha lipoic acid (ALA), liposomal glutathione (GSH) (Drug)
结局指标
主要结局
Change in Quality of Life Using SF-36 Survey
时间窗: Will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy
The SF-36 survey is a multipurpose, short-form health survey with 36 questions to evaluate health-related Quality of Life . It yields an eight-scale profile of scores as well as physical and mental health summary measures. It is a generic measure, as opposed to one that targets a specific age, disease, or treatment group.
COVID Severity of Symptoms Questionnaire
时间窗: Day 15, 28, end of months 2, 3, 4
This will evaluate the changes in the severity of symptoms over time with treatment.
Change in Time to Clinical Recovery (TTCR)
时间窗: Day 15 and 28 (month 1), and at the end of months 2, 3 and 4
Starting on day one of subjects' treatment, subjects will be asked if symptoms have improved or worsened, and the time it took for symptoms to change since their last treatment: (0 \[no change\], +1 \[improved within 7 days\], + 2 \[improved within 14 days\], +3 \[improved within 28 days\] + 4 \[symptom resolved\]; - 1 \[worsened within 7 days\], -2 \[worsened within 14 days\], - 3 \[worsened within 28 days\], - 4 \[debilitating last 28 days\]
Assess Changes in Symptoms of Post-Acute Sequelae of COVID (PASC)
时间窗: Symptoms will be evaluated at 2 weeks, 1-, 2-, 3- and 4 months post therapy
With the goal of reversing symptoms of Post-Acute Sequelae of COVID, this outcome measure aims to evaluate changes in symptoms before and after therapy, and determining which, if any symptoms are improved in each arm of the trial.
次要结局
未报告次要终点
研究者
Alpesh N Amin
Principal Investigator
University of California, Irvine