NCT04348877Unknown不适用
Plasma Rich Antibodies From Recovered Patients From COVID19
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- viral COVID-19 clearance
研究概览
简要总结
Prospective interventional study, single arm of purified convalescent plasma transfusion as an add on therapy for the standard of care treatment (national guideline) (Oseltamivir (75mg/12 hours for 5-10 days) and hydroxychroquine (400mg twice in first day, 200 twice for 4-9 days) ± Azithromycin 500mg daily for 5 days
详细描述
- Selection of donor according to the eligibility criteria
- Full medical history, concurrent medications, demographic data will be obtained.
- Complete clinical assessment with special emphasis on assessment of resolution of symptoms
- Body weight, height.
- A confirmatory diagnostic test result (e.g., nasopharyngeal swab) at the time of illness or serological test for SARS-CoV-2 antibodies after recovery will be collected
- COVID -19 PCR test by nasopharyngeal swab.
- Complete blood count with differential counts
- Viral screening (HBV, HCV, HIV & Syphilis): Conventional testing by chemiluminescence followed by nucleic acid testing (NAT)
- Donor's written consent
- Plasma collection:
- Donor to be connected to microprocessor controlled plasmapheresis machine containing single use disposable kit for every donor.
- A certain amount of blood is withdrawn by pump from the patient and immediately anticoagulated then centrifuged in the machine.
- Blood components are separated into different layers according to the density of each component.
- The plasma layer is collected and diverted into the collection bag while all other components are infused back to the patient, thus ending the first cycle.
- Cycles are repeated until collecting a total of 400 ml of filtered plasma in the collection bag; that is one complete therapeutic dose for one patient in need.
- Pathogen reduction/Viral inactivation by the Solvent/Detergent (S/D) method:
- SD method is the gold standard for inactivation of enveloped viruses HBV, HCV and HIV. All these viruses have a lipid outer coat enveloping the nucleic acid.
- Tri-N Butyl Phosphate (TNBP) acts as an organic solvent to remove lipids from the membranes of pathogens.Tween-20 is a non-ionic detergent that stabilizes TNBP and disrupts lipid bilayers, thus easing the extraction of lipids. Since the solvent is toxic, it is removed using a sterile vegetable oil (Castor oil).
- Measuring remnants of TNBP:
- By chromatography in Ain Shams Toxicology Center.
- Concentration should be less than 10 ppm.
- Screening phase for patients selection:
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18 -80 years old
- •Must have laboratory confirmed COVID-19
- •Must have severe or immediately life-threatening COVID-19, Severe disease is defined as: Dyspnea,Respiratory frequency ≥ 30/min,Blood oxygen saturation ≤ 93%,Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours Life-threatening disease is defined as: respiratory failure, septic shock, and/or multiple organ dysfunction or failure
- •Must provide informed consent by patient or his/her legal guardian or Professional Legal Representative
排除标准
- •Patient with mild or moderate COVID-19
- •Participation in any investigational clinical study, other than observational, within the past 30 days; or plans to participate in such a study at any time from the day of enrollment until 30 days post-treatment in the current study.
研究组 & 干预措施
Antibody-Rich Plasma
Other
400 millimeter of Antibody-Rich Plasma from COVID-19 recovered patients will be transfused to patients with severe or immediately life-threatening COVID-19
干预措施: Antibody-Rich Plasma from COVID-19 recovered patients (Other)
结局指标
主要结局
viral COVID-19 clearance
时间窗: 14 days
Two successive negative COVID-19 PCR analysis tests 72 hours apart
次要结局
- Decrease of radiological abnormalities(14 days)
- Clinical improvement(14 days)
研究者
Hossam Fahmy
Professor of Faculty of Medicine
Ain Shams University
研究点 (1)
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