Imatinib for the Treatment of SARS-COV-2 Induced Pneumonia: A Pilot Study
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 主要终点
- Primary endpoint: Disease Progression
研究概览
简要总结
A randomized controlled pilot study on the safety & efficacy of imatinib for the treatment of patient with moderate to severe SARS-COV-2 induced pneumonia.
详细描述
As the coronavirus disease (COVID-19) spreads worldwide, awaiting the development of a vaccine, researchers are looking among the arsenal of available drugs, for a potential cure or medication to improve patients' outcome. A highly elevated levels of cytokines in COVID-19 patients requiring ICU admission, has suggested that a "cytokine storm" was associated with disease severity. Data from cellular, animal models and clinical trials, showed a beneficial role of tyrosine kinase inhibitors in the regulation of inflammation, the maintenance of endothelial barrier integrity, as well as the expression of antiviral properties. This data is especially derived from imatinib, the most studied Abl family kinase inhibitor, that is currently in clinical use for multiple medical conditions. Based on this encouraging data, we hypothesize that imatinib might be beneficial for the treatment of patients with SARS-CoV-2 pneumonia, in the aim of preventing disease progression into the severe phenotype of hypoxic respiratory failure and acute respiratory distress syndrome.
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
- •Patients with PCR positive for SARS-COV-2
- •Hospitalized with moderate to severe respiratory symptoms as assessed by the Egyptian Ministry of Health National Guidelines
- •Informed consent explained & signed by patient or his 1st degree relatives or legally authorized representative.
排除标准
- •Pregnant women (or) breast feeding women
- •Patients younger than 18 years of age
- •Patients with known allergy to imatinib
- •Total bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) > 5x upper limit of normal (ULN).
- •Creatinine clearance (CrCl) < 30 mL/minute.
- •Patient already on mechanical ventilation at time of screening.
研究组 & 干预措施
Imatinib Standard Dose
Imatinib 400 mg oral tablet once daily for 21 days
In addition for the treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).
干预措施: Imatinib Mesylate (Drug)
Imatinib Low Dose
Imatinib 200 mg oral tablet once daily for 21 days.
In addition to the treatment for COVID-19 Pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).
干预措施: Imatinib Mesylate (Drug)
Control
Treatment for COVID-19 pneumonia according to the Egyptian National Protocol by the Ministry of Health (MOH).
干预措施: Standard of Care (Drug)
结局指标
主要结局
Primary endpoint: Disease Progression
时间窗: 30 Days
Proportion of patients with COVID-19 pneumonia progressed to critical illness in need for invasive mechanical ventilation.
次要结局
- Hospital Length of Stay(From inclusion to 30 days follow up)
- Improvement in Hypoxic Index(From inclusion to 30 days follow up)
- Radiological assessment(From inclusion to 30 days)
- Days on invasive mechanical ventilation(From inclusion to 30 days follow up)
- Inflammatory Markers(From inclusion to 30 days)
- Viral clearance(From inclusion to 30 days)
- Safety of Imatinib(From inclusion to 60 days)