Investigating Effect of Convalescent Plasma on COVID-19 Patients Outcome: A Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mortality changes in day 30
研究概览
简要总结
Coronavirus disease 2019 (COVID-19) was recognized as a pandemic on March 11, 2020 by the World Health Organization. The virus that causes COVID-19 (SARS-CoV-2) is easily transmitted through person to person and there is still no specific approach against the disease and mortality rate in severe cases is also significant. Therefore, finding effective treatment for the mortality of these patients is very important. In this study the investigators aim to determine the effect of Convalescent Plasma on COVID-19 patients Outcome through a Clinical Trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID-19 Patients
- •Consent to attend the study
- •Age 30 to 70 years
- •Don't be intubated
- •PaO2 / FiO2 is above 200 or Spo2 is greater than 85%.
- •Complete recovery from severe COVID-19 disease and hospital discharge
- •Consent to donate blood to the infected person
- •Age 30 to 60 years
- •Has normal CBC test results
- •Negative COVID-19 RT-PCR test
排除标准
- •A history of hypersensitivity to blood transfusions or its products
- •History of IgA deficiency
- •Heart failure or any other factor that prevents the transmission of of 500 ml plasma
- •Entering the intubation stage
- •Patients infected with blood-borne viral / infectious diseases
- •Underlying heart disease, low or high blood pressure, diabetes, epilepsy, and anything that may prohibit blood donation.
- •Use of banned drugs for blood donation (eg, ethertinate, acitretin, aliotretinoin, isotretinoin, antiandrogens, NSAIDs, etc.)
- •Use of different drugs
- •Other prohibited donations based on blood transfusion standards
研究组 & 干预措施
COVID-19 Patients
干预措施: Convalescent Plasma (Biological)
结局指标
主要结局
Mortality changes in day 30
时间窗: 30 days after plasma transmission
Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
Changes of Interleukin 6
时间窗: Day 7
Measurement of IL-6
Changes of C-reactive protein
时间窗: Day 7
Measurement of CRP
Mortality changes in day 10
时间窗: 10 days after plasma transmission
Measure of the number of deaths in a particular population, scaled to the size of that population, per unit of time.
Changes of tumor necrosis factor-α
时间窗: Day 7
Measurement of TNF-α
Changes of PaO2/FiO2 Ratio
时间窗: Day 7
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Changes of C-reactive protein
时间窗: Day 1
Measurement of CRP
Changes of C-reactive protein
时间窗: Day 3
Measurement of CRP
Changes of Interleukin 6
时间窗: Day 1
Measurement of IL-6
Changes of Interleukin 6
时间窗: Day 3
Measurement of IL-6
Changes of tumor necrosis factor-α
时间窗: Day 1
Measurement of TNF-α
Changes of tumor necrosis factor-α
时间窗: Day 3
Measurement of TNF-α
Changes of PaO2/FiO2 Ratio
时间窗: Day 1
Partial pressure of arterial oxygen/Percentage of inspired oxygen
Changes of PaO2/FiO2 Ratio
时间窗: Day 3
Partial pressure of arterial oxygen/Percentage of inspired oxygen
次要结局
- Radiological findings(Day 14)
- Changes of alanine transaminase (ALT)(Day 7)
- Changes of creatine phosphokinase (CPK)(Day 7)
- Number of days ventilated(Through study completion, an average of 2 weeks)
- Length of hospitalization(Through study completion, an average of 2 weeks)
- Changes of CD4(Day 7)
- Changes of CD8(Day 7)
- Changes of CD4/CD8 ratio(Day 7)
- Changes of Specific IgG(Day 7)
- Changes of leukocyte count(Day 7)
- Changes of aspartate transaminase (AST)(Day 7)
- Changes of Creatine kinase-MB (CK-MB)(Day 7)
- Changes of CD3(Day 7)
- Changes of lymphocyte count(Day 7)
- Changes of alkaline phosphatase (ALP)(Day 7)
- Changes of lactate dehydrogenase (LDH)(Day 7)
- Changes of CD3(Day 1)
- Changes of CD3(Day 3)
- Changes of CD4(Day 1)
- Changes of alanine transaminase (ALT)(Day 3)
- Changes of aspartate transaminase (AST)(Day 1)
- Changes of CD4(Day 3)
- Changes of aspartate transaminase (AST)(Day 3)
- Changes of alkaline phosphatase (ALP)(Day 1)
- Changes of alkaline phosphatase (ALP)(Day 3)
- Changes of CD8(Day 1)
- Changes of CD8(Day 3)
- Changes of CD4/CD8 ratio(Day 1)
- Changes of CD4/CD8 ratio(Day 3)
- Changes of lymphocyte count(Day 1)
- Changes of lymphocyte count(Day 3)
- Changes of leukocyte count(Day 1)
- Changes of leukocyte count(Day 3)
- Changes of alanine transaminase (ALT)(Day 1)
- Changes of lactate dehydrogenase (LDH)(Day 1)
- Changes of lactate dehydrogenase (LDH)(Day 3)
- Changes of creatine phosphokinase (CPK)(Day 1)
- Changes of creatine phosphokinase (CPK)(Day 3)
- Changes of Creatine kinase-MB (CK-MB)(Day 1)
- Changes of Creatine kinase-MB (CK-MB)(Day 3)
- Changes of Specific IgG(Day 1)
- Changes of Specific IgG(Day 3)
- Radiological findings(Within 2 hours after admission)
研究者
Amir Shamshirian
Principal Investigator
Mazandaran University of Medical Sciences