Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
With potential antiviral effects on severe acute respiratory syndrome (SARS) and as a methyl-xanthine derived inhibitor of phosphodiesterase-4, pentoxifylline basically functions as a hemorrheologic agent for a better circulation and oxygenation and exerts unique effects on immune modulation, inflammation and oxidative stress. As the main regulator of cAMP metabolism, posphodiesterase-4 plays a key role in proinflammatory and immune cells. Pentoxifylline plays its anti-inflammatory role by reducing the production of proinflammatory cytokines such as TNF-a, IL-1 and IL-6. Given its unique impacts on immune modulation, homeostasis and fibrinolysis and its supportive effects on oxidative stress and organ failure, pentoxifylline can constitute a multipurpose and generally-safe adjuvant therapy for COVID-19 patients.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive COVID-19 test
- •Age >/= 18 y.o.
排除标准
- •Allergic reaction to Pentoxifylline
- •Ongoing anticoagulation
- •History of GI bleeding
- •History of Seizures
- •Cardiac or other vascular stents
- •History of severe renal disease
- •History of intracranial hemorrhage.
研究组 & 干预措施
Pentoxifylline group
100 patients will receive standard treatment plus pentoxifylline 1200 mg/day
干预措施: Pentoxifylline (Drug)
Control group
100 patients will receive standard treatment plus placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Outcome
时间窗: 7 days
Number of Participants need hospitalization
次要结局
- Respiratory infection(7 days)
- Serious Adverse Events(7 days)
研究者
Mahmoud Samy Abdallah
Lecturer of Clinical Pharmacy, PhD.
Sadat City University