The Efficacy of Levamisole and Isoprinosine in the Treatment of COVID19: A Proposed Therapeutic Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 主要终点
- COVID 19 induced dyspnea in both groups
研究概览
简要总结
The use of both levamisole & Isoprinosine has both synergistic and complementary effect in the treatment of COVID 19 infection
详细描述
Study design: Randomized controlled trial, randomization by closed envelope technique Informed consent will be written for each patient of either group
At the beginning of the study all patients will have the following investigations done: CBC with differential, ESR, PCR for COVID 19, D dimer and CT chest and confirmed cases will included in the study
Pregnant and lactating women together with children with other comorbidities will be excluded from the study
Study groups:
Duration of the study is 4 weeks
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed COVID 19 infection (positive PCR, elevated ESR, leucopenia)
- •Clinical picture of COVID 19 infection including fever, malaise, sore throat, coughing, dyspnea, and runny nose
排除标准
- •Mild cases of COVID 19 that do not require hospitalization
- •Pregnant & lactating women
- •Children with other comorbidities
- •People who received previous treatment for COVID 19 in the last 2 weeks N.B. Diabetes and hypertension not excluded
研究组 & 干预措施
Proposed treatment group
Levamisole and isoprinosine
干预措施: Levamisole and isoprinosine (Drug)
Control group
hydroxychloroquine and azithromycin
干预措施: Azithromycin and hydroxychloroquine (Drug)
结局指标
主要结局
COVID 19 induced dyspnea in both groups
时间窗: 4 weeks
improvement of dyspnea by normalization of respiratory rate
COVID 19 induced fever in both groups
时间窗: 4 weeks
Improvement of fever in degrees celsius
COVID 19 viral load in both groups
时间窗: 4 weeks
PCR of COVID 19 changes from positive to negative
次要结局
- laboratory clearance in both groups: CRP in mg/dL(4 weeks)
研究者
Hagar El Sayed
Dermatology Lecturer Cairo University
Cairo University