Pilot Study Into Low Dose Naltrexone (LDN) and Nicotinamide Adenine Dinucleotide (NAD+) for Treatment of Patients With Post-COVID-19 Syndrome (Long-COVID19)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction of fatigue in post-COVID-19 syndrome by treatment with LDN and NAD+
研究概览
简要总结
Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with post-COVID-19 syndrome.
详细描述
This interventional pilot study will assess the use of low dose naltrexone (LDN) and NAD+ for the treatment of patients with post-COVID-19 syndrome (long-COVID-19).
Patients with a positive test for SARS-CoV-2 1-4 months before enrollment will be included. Subjects should have self diagnosed post-COVID19 syndrome and experiencing persistent fatigue since positive test. Patients will be screened using the fatigue survey and cases with a moderate to severe score will be included.
Patients will receive LDN and NAD+ treatment for 12 weeks. In this study, fatigue and quality of life will be assessed using validated surveys. Surveys will be conducted at baseline (at the time of enrollments, before treatment), and at 2, 4, 8, and 12 weeks. The improvement of scores from baseline levels will be assessed.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any ethnicity
- •Adequate cognitive function to be able to give informed consent
- •Technologically competent to complete web forms and perform video calls with the PI
- •Positive PCR test (polymerase chain reaction) result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) 1-4 months before enrollment
- •A fatigue score above 9 in the Chalder Fatigue scale upon enrollment
- •Willing to fill out regular questionnaires
- •Willing to use LDN and NAD patches
排除标准
- •Clinically significant kidney, heart, Hepatic impairment as determined by clinical judgement
- •Taking opioid analgesics, or undergoing treatment for opioid addiction
- •Opioid dependence or withdrawal syndrome
- •Known sensitivity to naltrexone
- •Suspected or confirmed pregnancy or breastfeeding
- •Known issues with using iontophoresis patches
- •Active cancers
- •Enrolled in another trial
- •Current users of LDN or NAD+
研究组 & 干预措施
Treatment with LDN and NAD+
LDN will be used at a dosage of 4.5 mg/day, which will be taken orally in the form of tablets. NAD+ will be administered using the IontoPatch iontophoresis patch containing 400 mg of NAD+ solution which is worn on the skin for 4-6 hours once per week.
干预措施: Naltrexone (Drug)
Treatment with LDN and NAD+
LDN will be used at a dosage of 4.5 mg/day, which will be taken orally in the form of tablets. NAD+ will be administered using the IontoPatch iontophoresis patch containing 400 mg of NAD+ solution which is worn on the skin for 4-6 hours once per week.
干预措施: NAD+ (Dietary Supplement)
结局指标
主要结局
Reduction of fatigue in post-COVID-19 syndrome by treatment with LDN and NAD+
时间窗: 12 weeks
Reduction of fatigue score from baseline as measured by the Chalder fatigue scale in post-COVID-19 syndrome by treatment with LDN and NAD+. The Chalder scale has a minimum value of 0 and a maximum value of 33, and the higher the score the more severe the fatigue symptoms are.
次要结局
- Improvement of quality of life in post-COVID-19 syndrome by treatment with LDN and NAD+.(12 weeks)