Impact of Different Treatment Modalities on Immunity Against COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Recovery rate from positive to negative swaps
研究概览
简要总结
The first version of this preprint article is registered on the 4th of May 2020 under the digital object identifier of:10.31219/osf.io/u56fc.
COVID-19 infections virus spread worldwide and impact many countries with sever economical sequences. The effective antiviral medication or vaccination for the virus is unavailable until the present date and it takes months or years to discover the effective treatment or test the efficacy of the discovered treatment.
Based on these facts, the human immune system against the virus may have an effective role to regulate the infection and reduce the mortality rate among the infected patients. This proposed research article aims to explore the available medication/ natural supplementation to boost the immunity system of the patients against COVID-19 infections and reduce the mortality rate among infected patients. Methods: a proposed clinical trial will be carried out to investigate the effect of the different treatment modalities on the human immune system against COVID-19 infection.
详细描述
Natural supplementations have many reported effects on the human health ranged from immunity boosting to effective antiviral effect. Omeg-3 as an example affect the human health by many mechanisms e.g. Anti-oxidant, immunity boosting agent. Moreover, Omega-3 exerts an antiviral effect on Flu virus by inhibiting influenza virus replication 1. On the other hand, black seed supplementation exerts a chelation effect on sickle cell anemia patients and inhibits Human Heme Metabolism 2. Moreover, black seed exerts an antiviral effect on the replication of old coronavirus and the expression of (TRP-genes) family 3. In addition, Omega-3 regulates the human immunity against bacterial and viral infections 4. During the past years, many natural sources exerts an antimalarial effect with perfect reported results 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic with respiratory or systemic symptoms
- •Positive nasopharyngeal swab for COVID-19
- •CT imaging showing viral pneumonia
- •Temperature 38°C
- •Respiratory rate < 25 /min
- •Oxygen saturation (pulse oximetry) >95%
排除标准
- •Pregnant or breast feeding
- •Hepatic failure Child-Pugh C
- •Negative swab test of (SARS)-(CoV-2)
- •Expected life is less than 24 hours
- •End-stage lung disease
研究组 & 干预措施
Omega-3/thymoquinone supplementation
10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA & 200-300mg DHA) (3% thymoquinone) per day for one month.
In addition to the standard care
干预措施: Omega 3/Nigella Sativa Oil (Drug)
Omega-3/thymoquinone / Indian Costus supplementation
10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA & 200-300mg DHA), (3% thymoquinone),(Indian Costus) per day for one month.
In addition to the standard care
干预措施: Omega 3/Nigella Sativa Oil/Indian Costus (Drug)
Omega-3/thymoquinone / Quinine pills
10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA & 200-300mg DHA), (3% thymoquinone),(1g Quinine) per day for one month.
In addition to the standard care
干预措施: Omega 3/Nigella Sativa Oil/Quinine pills (Drug)
Omega-3/thymoquinone / Anise seed capsule
10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA & 200-300mg DHA), (3% thymoquinone),(450mg anise seed) per day for one month.
In addition to the standard care
干预措施: Omega 3/Nigella Sativa Oil/Anise seed capsule (Drug)
Omega-3/thymoquinone / Deglycyrrhizinated Licorice
10 patients that will receive every 14-days Omega-3/thymoquinone supplementation (300-400mg EPA & 200-300mg DHA), (3% thymoquinone),(Deglycyrrhizinated Licorice 800 mg ) per day for one month.
In addition to the standard care
干预措施: Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice (Drug)
Active Comparator: standard care
The standard protocol care for COVID-19 approved from ministry of health at Saudi arabia
干预措施: Active Comparator (Drug)
结局指标
主要结局
Recovery rate from positive to negative swaps
时间窗: 14 Days
Percentage of patients returned to negative swaps of COVID-19
Respiratory indexes
时间窗: 10 Days
P O2/Fi O2 which reflects patients' oxygen saturation
Length of hospitalization
时间窗: 10 Days
Number of days for hospitalization
C-reactive protein mg/L
时间窗: 25 Days
C-reactive protein milligrams per deciliter correlated with inflammation
Clinical improvement
时间窗: 30 Days
Time to Clinical recovery
Remission of lung inflammation in CT or X-ray
时间窗: 30 Days
Number of days to report lungs recovery in chest X ray or CT
leukocytes count μl
时间窗: 30 Days
leukocytes in microliter correlated with mortality
Lipid profile [LDL, HDL, Total cholesterol ]
时间窗: 14 Days
Mg/dl correlated with lipid peroxidation that linked to oxidative stress
Fever to normal temperature in days
时间窗: 15 Days
Number of days for fever remission T=37.5°C
(PCR levels) polymerase chain reaction assay levels
时间窗: 10 Days
Change of (PCR levels) \> 50% in comparison with PCR levels at the admission
Serum Ferritin ng/ml
时间窗: 25 Days
Serum Ferritin Nanograms per milliliter correlated with iron overload and illness severity
Lactic acid dehydrogenase U/L
时间窗: 25 Days
Lactic acid dehydrogenase unit per litter correlated with illness severity
total plasma antioxidant capacity
时间窗: 14 Days
Evaluate the antioxidant response against the free radicals produced in COVID-19 infection measured by ELISA
次要结局
未报告次要终点
研究者
Mohamed Medhat Abdelwahab Gamaleldin
Clinical researcher
Beni-Suef University