Pilot Study Into the Use of Metformin and Low Dose Naltrexone (LDN) for Patients With Coronavirus Disease 2019 (COVID-19) - Assessment of Short and Long Term Effects
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN
研究概览
简要总结
Study into the effects of daily use of metformin and low-dose naltrexone (LDN) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19.
详细描述
The researchers will treat 40 patients with metformin (1500 mg/day) and LDN (4.5 mg/day) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19. These 40 patients will be compared with 40 control patients who will receive regular care. All patients will be asked to complete surveys at baseline and after 1, 2, and 4 weeks after initiation of treatment. The difference with baseline at each time point will be assessed. The surveys will assess COVID-19 symptoms severity.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-70
- •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 (polymerase chain reaction) test result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) within the last 10 days
- •At least two COVID-19 symptoms as assessed by laboratory or patient self-reporting started within the last 3 days
- •Willing to fill out regular questionnaires
- •Willing to take metformin and LDN
排除标准
- •Clinically significant hepatic, renal, or cardiac impairment (as determined by previous clinical judgement)
- •Hypoglycemia
- •Currently on drugs for COVID-19
- •Hospitalization for COVID-19
- •(Suspected) pregnancy or breastfeeding
- •Active cancer
- •Uncontrolled mental health issues
- •On any medication with major interactions with metformin or LDN
- •Taking opioid analgesics, or being treated for opioid addiction/recovery
- •Opioid dependence or withdrawal syndrome
- •Known sensitivity to metformin or naltrexone
- •Current users of metformin or naltrexone
研究组 & 干预措施
Treatment with Metformin and LDN
Patients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks.
干预措施: Metformin (Drug)
Treatment with Metformin and LDN
Patients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks.
干预措施: Naltrexone (Drug)
结局指标
主要结局
Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN
时间窗: 1 week
Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale. The scale has a minimum score of 0 and a maximum of 24, with values ranging from 4-11 are considered 'mild symptoms', scores ranging 12-19 are considered 'moderate', and scores 20-24 are considered 'severe'.
Reduction of COVID-19 symptoms after 2 weeks of treatment with metformin and LDN
时间窗: 2 weeks
Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale. The scale has a minimum score of 0 and a maximum of 24, with values ranging from 4-11 are considered 'mild symptoms', scores ranging 12-19 are considered 'moderate', and scores 20-24 are considered 'severe'.
次要结局
- Reduction in mortality(4 weeks)
- Reduction in recovery time from COVID-19(4 weeks)
- Reduction in hospitalizations(4 weeks)
- Reduction in requirement of additional treatment due to COVID-19(4 weeks)