Ivermectin Inhalation Forms in the Management of COVID-19 Egyptian Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 主要终点
- PCR of SARS-Cov2 RNA
研究概览
简要总结
The global escalation of COVID19 pandemic has put the health care system under pressure with urgent need for treatment. In the absence of vaccine and approved drug against SARS-COV2 over the past 6 months, the health authorities were obliged to re-purpose existing drugs to fight this pandemic.
详细描述
Ivermectin is a well-known FDA-approved pan antiparasitic drug with high safety profile and potential therapeutic effects against COVID 19. It has been previously investigated as an antiviral agent. It showed 5000 fold reduction of SARS COV 2 viral RNA in-vitro studies.
However, some researchers questioned its efficacy in the oral form as very high doses will be required to achieve a proper tissue concentration and viricidal effect in the respiratory system.
Our hypothesis is that, since COVID-19 has shown to be particularly damaging to the respiratory system, using inhaled forms of Ivermectin will deliver the drug directly to the infection site and make it a treatment option.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild to moderate severity who are confirmed to be positive for SARS COV 2.
排除标准
- •patients with severe form of COVID-19 or those who are on ventilatory support or those with cytokine storm
研究组 & 干预措施
Ivermectin nasal spray
Ivermectin administered as nasal spray (one ml in each nostril two times daily)
干预措施: Ivermectin nasal (Drug)
Ivermectin oral
Ivermectin administered orally (one tablet 6 mg three times daily) for 72 hours plus the standard care of COVID-19 cases.
干预措施: Ivermectin oral (Drug)
standard care
COVID-19 cases will receive standard of care [oxygen via masks or ventilators]
干预措施: standard care (Other)
结局指标
主要结局
PCR of SARS-Cov2 RNA
时间窗: 14 days
Negative PCR result of SARS-Cov2 RNA in COVID19 patients
次要结局
未报告次要终点
研究者
Prof. Dr. Kamal Mohammed Okasha
Vice President
Tanta University