The Study of Quadruple Therapy Zinc, Quercetin, Bromelain and Vitamin C on the Clinical Outcomes of Patients Infected With COVID-19
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- days of stay at hospital after treatment and discharge
研究概览
简要总结
There are currently no antiviral drugs with proven efficacy nor are there vaccines for its prevention. Unfortunately, the scientific community has little knowledge of the molecular details of SARS-CoV-2 infection. The drugs we are chosen are used as clinical trials for antiviral and there is no proven guide for specificity and effectiveness against the virus so the results are different Now the clinical trials and research authorities are work speedily to target the most proven treatment for the virus so anything is infantile until now. the covid-19 with time be more explained by scientists it is steroid response disease and cause thromosis and cytokine storm , the aim of the study to inhibit viral replication and decrease the severity of the disease as antiviral and anticytokine storm , antithrombosis Zinc is a mineral element needed to regulate adaptive immune cells' functions. Higher level of intracellular zinc showed to increase intracellular pH; which affect on RNA-dependent RNA polymerase and decrease replication mechanism of RNA viruses. Therefore, drugs that described as zinc ionophores could be used with zinc supplement to act as antiviral against many RNA viruses including SARS-CoV-2 Quercetin is natural compound act as zinc ionophore to cause zinc influx intracellular.
Quercetin is a safe natural anti-oxidant and anti-inflammatory polyphenolic compound that found in various natural sources include onion, red grapes, honey and citrus fruits. It was shown that quercetin has the ability to chelate zinc ions and act as zinc ionophore. Therefore, quercetin could have antiviral activity against many RNA viruses . Quercetin, a flavonoid found in fruits and vegetables, has unique biological properties that may improve mental/physical performance and reduce infection risk ; These properties form the basis for potential benefits to overall health and disease resistance, including anti-carcinogenic, anti-inflammatory, antiviral, antioxidant, and psychostimulant activities, as well as the ability to inhibit lipid peroxidation, platelet aggregation and capillary permeability, and to stimulate mitochondrial biogenesis .There are various studies that report the immunomodulatory effect of bromelain . Bromelain activates natural killer cells and augments the production of granulocyte-macrophage-colony stimulating factor, IL-2, IL-6 and decreases the activation of Thelper cells. Thus, bromelain decreases the majority of inflammatory mediators and has demonstrated a significant role as an anti-inflammatory agent in various conditions Vitamin C is known as an essential anti-oxidant.,and enzymatic co-factor for physiological reactions such as hormone production, collagen synthesis and immune potentiation . Naturally, an insufficiency of vitamin C leads to severe injuries to multiple organs, especially to the heart and brain, since they are both highly aerobic organs that produce more oxygen radicals. In fact, studies of in vivo effect on vitamin C are difficult since most animals, except human and some primate, are capable of synthesizing vitamin C endogenously
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •positive confirmed PCR covid-19
- •moderate to severe cases
- •obtained consent
- •must be able to swallow tablets
排除标准
- •Patients who live outside Saudia Arabia
- •Pregnant women: Current known pregnancy positive pregnancy test.
- •Lactating women.
- •Documented allergy to pineapple or to quercetin
- •Documented history of mental illnesses
研究组 & 干预措施
Quercetin
Quercetin 500 g of quercetin Quercetin will be administered orally once daily, in the morning before breakfast for 5-10 days or patient improves or discharged
干预措施: Quercetin (Drug)
Quercetin
Quercetin 500 g of quercetin Quercetin will be administered orally once daily, in the morning before breakfast for 5-10 days or patient improves or discharged
干预措施: bromelain (Dietary Supplement)
Quercetin
Quercetin 500 g of quercetin Quercetin will be administered orally once daily, in the morning before breakfast for 5-10 days or patient improves or discharged
干预措施: Zinc (Drug)
Quercetin
Quercetin 500 g of quercetin Quercetin will be administered orally once daily, in the morning before breakfast for 5-10 days or patient improves or discharged
干预措施: Vitamin C (Drug)
结局指标
主要结局
days of stay at hospital after treatment and discharge
时间窗: 28 days
speed the days of recovery and discharge from hospital
serum zinc before and after treatment
时间窗: 5-10 days
the level of serum zinc is very important especially at chronic diseases
次要结局
- questionnaire including parameters like BMI,,smoking , underling diseases, immunological treatment ,(28 days)
- day of negative conversion for nasopharyngeal swab for rt-PCR FOR covid-19(28 days)
研究者
Amr kamel khalil Ahmed
director of mobile team tuberculosis ghubera, tuberculosis control program
Ministry of Health, Saudi Arabia
