Clinical Trial for Oral Formula of Vanillin and Wheat Germ Oil for Treatment of Mild and Moderate COVID-19 Viral Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. Mean change in the disease severity (clinical assessment).
研究概览
简要总结
- The study is a randomized clinical trial to assess a natural formula of vanillin & wheat germ oil to treat and stop the clinical progression of COVID-19.
- The study aims to treat people with mild-to-moderate COVID-19 before their cases become severe.
- The study duration is a 5-day experimental intervention and an extended 4 weeks follow up.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PCR confirmed diagnosis for COVID-
- •Age ≥18 years.
- •Both genders
- •The disease started within 7 days (ideally 72 hours) of diagnosis or clinical deterioration.
- •Patients diagnosed as mild or moderate
排除标准
- •Patients diagnosed with severe Illness: Individuals who have SpO2 <92% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg, respiratory frequency >30 breaths/min, or lung infiltrates >50%.
- •General: advanced kidney disease; advanced liver disease; pregnancy (known or potential) or lactation, and advanced cardiovascular diseases.
- •Allergy to Vanilla flavor, vanillin, or wheat germ oil
- •Active cancer
研究组 & 干预措施
Intervention (low dose)
Two capsules twice daily for 3 days then one capsule twice daily for 2 days
干预措施: Oral Capsule (Drug)
Intervention (high dose)
two capsules three times daily for 3 days, followed by one capsule three times daily for 4 days
干预措施: Oral Capsule (Drug)
结局指标
主要结局
1. Mean change in the disease severity (clinical assessment).
时间窗: 3-5 days
Time taken for the changes from moderate or mild or complete recovery/FDA assessment of key COVID-19-related symptoms score
2. Rate of disease remission.
时间窗: 3-5 days
For mild/moderate symptoms patients: fever, cough and other symptoms relieved
3. Hospitaization & Survival rate
时间窗: up to 4 weeks
Comparing the influence of the intervention on the hospitalization \& Survival rate followed for up to 4 weeks.
次要结局
- 5. Mean change in C reactive protein (CRP)(3-5 days)
- 9. The mean change in serum interleukin-6 (IL-6)(3-5 days)
- 4. Mean change in complete blood picture(3-5 days)
研究者
Ahmed Ibrahim ElMallah
Professor of Pharmacology & Therapeutics, Faculty of Pharmacy, Alexandria University
Alexandria University