Impact of Levamisole and Isoprinosine in Immune-prophylaxis of Egyptian Healthcare Workers Facing COVID-19
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Decrease the incidence of COVID-19 infection or its severity
研究概览
简要总结
This randomized open labeled clinical trial will include one hundred healthy healthcare workers who will be randomly assigned into four groups of twenty-five each to receive either levamisole, Isoprinosine, combined levamisole and isoprinosine or no-intervention for two months to detect the impact of Levamisole and Isoprinosine as immune-prophylaxis on the incidence of COVID-19 infection. Participants will be followed-up for three months clinically and laboratory. Blood samples will be collected prior to randomization and during follow up.
详细描述
One hundred healthy health workers will be randomly assigned to receive either Levamisole, Isoprinosine, Levamisole and Isoprinosine or no-intervention for two months. Written informed consent will be obtained from all participants.
During the study:
- Participants will be assessed by detailed questionnaire, clinically and laboratory investigations for COVID 19 Detailed questionnaire for: job description, site of isolation hospital, duration of contact, time of exposure, methods of protection Clinically for any symptoms suggestive of COVID19: fever, plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose, plus Laboratory: Sampling of the following will be withdrawn from all participants at beginning and end of the study: COVID 19 IgM (for recent infection) or IgG or (old infection)
- Assessment of the modulatory effect of the drugs will be done by one or more of the following parameters: (at beginning of the study, 2 weeks, 1 month, 2-month, 3 month)
- Neutrophil function test
- Natural killer cell count and activity.
- T cell count and B cell subsets by flowcytometry and activity markers
- Quantitative immunoglobulines Levels (IgG, IgM, IgA, IgE)
- Assessment of the drug safety at beginning of the study and every two weeks except for complete blood count every week:
- Urine analysis
- Complete blood count with differential to determine total white blood cell count, absolute neutrophilic count (to exclude agranulocytosis) and absolute lymphocytic count (for COVID19).
- Serum uric acid
- Renal functions tests
- Liver function tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adult > 18 years old
- •Both Gender (male and female)
- •Healthy health care workers employed by one of the hospitals involved in the study
- •Negative serology at day 0 for COVID19 infection.
- •Evidence of a personally signed and dated informed consent document
排除标准
- •Participations in other investigational clinical trials for the treatment or prevention of SARS-COV-2 infection
- •Previous or recent COVID 19 infection (previously had a SARS-CoV-2 positive test result or confirmed case of SARS-CoV-2 infection or positive serology at day 0)
- •Any medical illness
- •Has a congenital immunodeficiency, including specific deficiencies of the interferon-gamma pathway
- •Participants receiving steroids, cytotoxic immunosuppressive agents, radiotherapy.
- •Participants who have received any other immunotherapy.
- •Participants with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction and severe gastric ulcer.
- •Participants receiving allopurinol, indomethacin, colchicine or diuretics.
- •Participants with hematological problems.
- •Known hypersensitivity reactions or Wheat Allergy
- •Pregnant and lactating females.
- •Refusal to sign the informed consent form
- •Refusal of participation
研究组 & 干预措施
Levamisole
Oral Levamisole 150 mg/day for two days per week for two months
干预措施: Levamisole (Drug)
Isoprinosine
Oral Isoprinosine 1 g 3 times per day daily for two months
干预措施: Isoprinosine (Drug)
Levamisole and Isoprinosine
Oral Levamisole 150 mg/day for two days per week and Oral Isoprinosine 1 g 3 times per day daily for two months
干预措施: Levamisole and Isoprinosine (Drug)
结局指标
主要结局
Decrease the incidence of COVID-19 infection or its severity
时间窗: 6 months
Detect if Levamisole and Isoprinosine can decrease the incidence of COVID-19 infection
次要结局
未报告次要终点
研究者
Maged Mohammed Refaat
Professor of Allergy and Clinical Immunology.Faculty of Medicine Ain Shams University
Ain Shams University