Remdesivir Versus Remdesivir- Ivermectin Combination Therapy in Severe and Critically Ill Covid-19
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- 1- Improvement in level of oxygenation
研究概览
简要总结
Recent study reported in vitro synergistic interaction between two FDA approved drugs, remdesivir (RDV) and ivermectin (IVM) resulting in enhanced antiviral activity against SARS-CoV-2, the causative pathogen of COVID-19. The aim of the current study is comparing the efficacy and safety of combining remdesivir and ivermectin versus using remdesivir alone in patients with severe COVID-19.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, hospitalized severe COVID-19 patients; both genders; given informed consent (COVID-19 infection confirmed by PCR, severe illness is defined as patients with SpO2 ≤94% on room air, including patients on supplemental oxygen).
排除标准
- •patients under 18 years old, pregnant ladies, advanced renal diseases (cr. Clearance < 30 ml/hr), raised liver enzymes> 3 folds of normal, arrhythmia.
研究组 & 干预措施
Combination remdesivir plus ivermectin group
(The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days)
干预措施: Ivermectin (Drug)
结局指标
主要结局
1- Improvement in level of oxygenation
时间窗: By arterial blood gas and non-invasive pulse oximeter at date of randomisation, after 1 hour then on daily bases in stable cases till time of patient discharge or death
Change in partial pressure of Oxygen and oxygen saturation
2- Need for ventilator support
时间窗: From date of randomisation to patient discharge from hospital or death.
either noninvasive or invasive mechanical ventilation.
3- Length of hospital stay
时间窗: From date of randomisation to date of patient discharge from hospital or death.
duration of admission in days
5- Mortality
时间窗: Through study completion, an average of 3 months
mortality rates in both groups
4- Development of complication
时间窗: From starting to the end of ivermectin therapy (0 to the end of 4th day)
allergic reactions, arrhythmia, hepatic toxicity.....
次要结局
未报告次要终点
研究者
Maiada K. Hashem
Lecturer
Assiut University