Efficacy and Safety of Inhaled Ivermectin in the Treatment of SARS-COV-2 (COVID-19)
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Rate of virological cure by Rt -PCR for COVID -19 using ivermectin when compared to standard treatment
研究概览
简要总结
Coronavirus disease-19 is global healthcare crisis. Till May 20, 2020, there were approximately 4,789,205 cases and 318,789 related mortalities were identified globally. This dramatic situation led to healthcare service collapse in many countries. Each country developed its own action plan depending on healthcare expertise and the available resources. There is no definitive therapy for Coronavirus disease-19 up till now. Many current and investigational drugs are used nowadays. Recent reports suggest a beneficial role of Ivermectin in the management of Coronavirus disease-19. A notice that necessitates further clinical studies.
The aim of this study is to assess the efficacy and safety of the usage of inhaled ivermectin in the management of Coronavirus disease-19.
详细描述
Coronavirus disease-19 (COVID-19) is a pandemic disease which is caused by the SARS-CoV2 virus. It is one of the biggest single-stranded RNA viruses. SARS-CoV2 Viral polyproteins are responsible for viral replication and transcription while its protease enzymes are responsible for polypeptides cleaving and immune system blockage. They are considered to be an important therapeutic target.
Host immunological response against SARS-CoV2 could affect the disease outcome. Patients requiring ICU admission have higher levels of interleukins 6 - 10, tumor necrosis factor α (TNF-α), and fewer CD4+ and CD8+ T cells. The level of cytokines and lymphopenia is associated with pulmonary damage and respiratory distress.
Till now, there is no definitive therapy for COVID-19. Multiple current and investigational drugs are used such as Hydroxychloroquine, lopinavir/ritonavir, and Remdesivir.
Ivermectin: A potent anti-parasitic drug has shown to have an in-vitro antiviral activity against a broad range of viruses. It inhibits the interaction between the human immunodeficiency virus-1 (HIV-1) integrase protein (IN) and the importin (IMP) α/β1. But on the other hand, Ivermectin showed limited efficacy against DENV in phase III clinical trial that was done in Thailand in 2014-2017. Recent Studies proved the In-vitro effect and "subsequently" the possible therapeutic role of Ivermectin in the management of SARS-CoV2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both sexes
- •Age above 18
- •Test positive for COVID-19 using Reverse transcription polymerase chain reaction (RT-PCR) prior to the start of study.
- •Willing to participate in the study
- •Mild to moderate severity index according to the WHO criteria
排除标准
- •Hypersensitivity to the study drug.
- •History of co-morbid conditions such as: uncontrolled hypertension and diabetes, retinal problems and chronic liver and renal disease.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
Group (A) received both oral and inhaled ivermectin in addition to the standard of care.
use oral and inhaled ivermectin
干预措施: Ivermectin Powder (Drug)
B) received oral ivermectin in addition to the standard of care
receive oral ivermectin
干预措施: Ivermectin Powder (Drug)
c) received inhaled ivermectin in addition to the standard of care
received inhaled ivermectin
干预措施: Ivermectin Powder (Drug)
结局指标
主要结局
Rate of virological cure by Rt -PCR for COVID -19 using ivermectin when compared to standard treatment
时间窗: througout the study completion up to one year(for every case must be done after 2 weeks from the start of treatment).
All PCR for COVID-19 must be negative
次要结局
- resolution of pneumonia(througout the study completion up to one year (for every case must be done after 2 weeks from the start of treatment).)
研究者
Mahmoud Elbendary
Professor of Tropical Medicine and Hepatogastroenterology
Mansoura University