Exchange Transfusion Versus Plasma From Convalescent Patients With Methylene Blue in Patients With COVID-19
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- improvement of condition
研究概览
简要总结
The aim of this project is to introduce way for treatment of patients with severe COVID-19 disease with respiratory complications.
详细描述
Study Tools AND/ OR procedure
The patients were subjected to the following:
Clinical parameters:
Complete history taking and thorough clinical examination
- Laboratory parameters:
- CBC with differential counts.
- Reticulocytic count.
- Blood film for shistocytes.
- Serum ferritin and transferrin saturation.
- D dimer.
- Liver function tests, kidney function tests, electrolytes.
- ESR.
- CRP.
- LDH.
- Viral markers (HCV Ab, HBsV AG, HIV Ab).
- ADAM'S 13 assays.
- Serum soluble CD 25.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients are 18 years old or above.
- •Inpatients diagnosed as severe COVID - 19 disease according to WHO criteria.
- •CT chest with extensive lung disease (ground-glass and consolidative pulmonary opacities).
- •O2 saturation less than 93% resting.
- •Respiratory rate equal or more than 30 per minute.
排除标准
- •Patients with pregnancy and lactation.
- •Renal failure and heart failure.
- •Contraindication for plasma or blood transfusion.
研究组 & 干预措施
Exchange transfusion
Will receive exchange transfusion by venesection of 500cc blood with good replacement of one unit packed washed RBCs daily for 3 days according to daily clinical and investigational follow up
干预措施: exchange blood transfusion from normal donor (Biological)
Methylene blue with plasma
Will receive IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow up.
干预措施: plasma from convalescent patients with COVID-19 (Biological)
Methylene blue with plasma
Will receive IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow up.
干预措施: Methylene Blue 5 MG/ML (Drug)
Exchange transfusion and methylene blue with plasma
Will receive exchange transfusion by venesection of 500cc blood with good replacement of one unit packed washed RBCs and IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow up.
干预措施: exchange blood transfusion from normal donor (Biological)
Exchange transfusion and methylene blue with plasma
Will receive exchange transfusion by venesection of 500cc blood with good replacement of one unit packed washed RBCs and IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow up.
干预措施: plasma from convalescent patients with COVID-19 (Biological)
Exchange transfusion and methylene blue with plasma
Will receive exchange transfusion by venesection of 500cc blood with good replacement of one unit packed washed RBCs and IV methylene blue 1 mg/kg IV over 30 minutes with 200 CC plasma from convalescent matching single patient by plasma extractor machine for 3 days according to daily clinical and investigational follow up.
干预措施: Methylene Blue 5 MG/ML (Drug)
结局指标
主要结局
improvement of condition
时间窗: three to five days days
improvement of general condition of the patients as the ventilator parameters and serum level of ferritin , D dimer, CBC, oxygen level in blood and patient o2 saturation
次要结局
- change in organs function with PFS and OS(0ne month)
研究者
Mohamed Mahmoud Moussa
Professor Of Internal Medicine and Hematology -BMT
Ain Shams University