Open Label, parallel arm, phase I/II clinical trial to evaluate Safety and efficacy of Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Safety, efficacy.
研究概览
简要总结
Background:
COVID-19 is a condition caused by infection with Corona Virus (SARS-CoV-2). This virus has a high transmission rate and is spreading at very high rates, causing a worldwide pandemic. The number of infections of COVID-19 worldwide has killed thousands and is continually rising. The novel corona virus attacks the human body by attaching to the angiotensin-converting enzyme-2 (ACE2), a protective enzyme against lung damage. In addition, the cellular serine protease TMPRSS2 for HCoV-19 Spike protein priming is also essential for the host cell entry and spread. Corona viruses can be deadly, in large part because they cause "cytokine storms." These storms result from imbalances between pro-inflammatory and anti-inflammatory proteins called cytokines, which can cause extreme inflammation and respiratory complications. Respiratory distress kills hundreds of thousands of people each year worldwide, and hundreds of clinical trials are testing drugs to treat it.
Purpose:
The objective of this study is to investigate the potential use of convalesecent plasma in patients with Corona Virus SARS-CoV-2 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •18 years and older (male or female) -Laboratory confirmation of COVID – 19 -CT image is characteristic of 2019 novel corona virus pneumonia (optional) -Sign a consent form and follow the test plan and follow-up process.
- •Inclusion criteria for donors of plasma -18 years and older (male or female) -Patients who have recovered from COVID-19 and who have been discharged from COVID -19 treatment centres or units could be potential donors for CP, from 28 days after their day of discharge.
- •COVID patients who have been discharged according to the WHO criteria as: 1) clinically asymptomatic and 2) twice tested negative for SARS-CoV-2 by molecular techniques, should be considered as potential donors.
- •The two samples for SARS-CoV-2 testing should be taken at least 48 hours apart, and the test results should be negative on each sample.
- •The donors selected for donation should be RNA negative for COVID and for the transfusion transmissible infections (HIV 1/2, HBV, HCV, malaria and syphilis).
- •Sign a consent form and follow the test plan and follow-up process.
排除标准
- •Patients with autoimmune disease in the past or screening -Those who have serious disease that affect their overall survival as decided by the treating clinican -Self reports HIV or syphilis infected persons -Pregnant or lactating women -Continuous use of immunosuppressive agents or organ transplants in the past 6 months.
- •Exclusion criteria for donors -Patients who become sick again after getting discharged -RNA positive for COVID or TTI positive.
结局指标
主要结局
Safety, efficacy.
时间窗: Viral load (RT-PCR)- Day -2, Day 1, Day 3, Day 7, Day 14 | Eg. CT chest- Day -2, Day 3, Day 7 and Day 14 | Pao2/Fio2 and Sequential Organ Failure assessment (SOFA)- Day 0, Day 1, Day 3, Day 7 and Day 14 | Remaining parameters will be checked on Day 0, Day 1, Day 3, Day 7, Day 14 and Day 28
Improvement of clinical symptoms including duration of fever, respiratory distress, pneumonia, cough, sneezing, and diarrhea within 3 days of the convalescent plasma transfusion.
时间窗: Viral load (RT-PCR)- Day -2, Day 1, Day 3, Day 7, Day 14 | Eg. CT chest- Day -2, Day 3, Day 7 and Day 14 | Pao2/Fio2 and Sequential Organ Failure assessment (SOFA)- Day 0, Day 1, Day 3, Day 7 and Day 14 | Remaining parameters will be checked on Day 0, Day 1, Day 3, Day 7, Day 14 and Day 28
Side effects measured by Chest Radiograph.
时间窗: Viral load (RT-PCR)- Day -2, Day 1, Day 3, Day 7, Day 14 | Eg. CT chest- Day -2, Day 3, Day 7 and Day 14 | Pao2/Fio2 and Sequential Organ Failure assessment (SOFA)- Day 0, Day 1, Day 3, Day 7 and Day 14 | Remaining parameters will be checked on Day 0, Day 1, Day 3, Day 7, Day 14 and Day 28
Routine blood biochemical parameters including renal and liver function tests.
时间窗: Viral load (RT-PCR)- Day -2, Day 1, Day 3, Day 7, Day 14 | Eg. CT chest- Day -2, Day 3, Day 7 and Day 14 | Pao2/Fio2 and Sequential Organ Failure assessment (SOFA)- Day 0, Day 1, Day 3, Day 7 and Day 14 | Remaining parameters will be checked on Day 0, Day 1, Day 3, Day 7, Day 14 and Day 28
Oxygen Saturation, Pao2/Fio2.
时间窗: Viral load (RT-PCR)- Day -2, Day 1, Day 3, Day 7, Day 14 | Eg. CT chest- Day -2, Day 3, Day 7 and Day 14 | Pao2/Fio2 and Sequential Organ Failure assessment (SOFA)- Day 0, Day 1, Day 3, Day 7 and Day 14 | Remaining parameters will be checked on Day 0, Day 1, Day 3, Day 7, Day 14 and Day 28
Decrease in viral load as detected by PCR, serum antibody titer.
时间窗: Viral load (RT-PCR)- Day -2, Day 1, Day 3, Day 7, Day 14 | Eg. CT chest- Day -2, Day 3, Day 7 and Day 14 | Pao2/Fio2 and Sequential Organ Failure assessment (SOFA)- Day 0, Day 1, Day 3, Day 7 and Day 14 | Remaining parameters will be checked on Day 0, Day 1, Day 3, Day 7, Day 14 and Day 28
Sequential Organ Failure Assessment (SOFA)
时间窗: Viral load (RT-PCR)- Day -2, Day 1, Day 3, Day 7, Day 14 | Eg. CT chest- Day -2, Day 3, Day 7 and Day 14 | Pao2/Fio2 and Sequential Organ Failure assessment (SOFA)- Day 0, Day 1, Day 3, Day 7 and Day 14 | Remaining parameters will be checked on Day 0, Day 1, Day 3, Day 7, Day 14 and Day 28
次要结局
- - Rate of mortality(- Marker of immunological function, ferritin, CRP, d-dimer)