Randomized Prospective Clinical Study for Efficacy of Anti-Corona VS2 Immunoglobulins Prepared From COVID19 Convalescent Plasma in Prevention of Infection in High Risk Groups as Well as Treatment of Early Cases of COVID19 Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Efficacy of COVID19 hyper immunoglobulins for patients
研究概览
简要总结
Preparation of safe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients to be used to:
- To determine efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19
- To determine efficacy of anti-SARS-CoV-2 hyper immunoglobulins in the prevention of infection in high risk groups exposed to SARS-CoV-2 infection
详细描述
The current COVID19 pandemic poses a huge challenge on health authorities and infrastructure due to rapid progression of infection with an estimated rate of severe disease that needs hospitalization and medical intervention. It is also noteworthy that health care workers are at high risk of contracting COVID19 when dealing with cases.
Previous experience with Corona SARS demonstrated a therapeutic benefit of using convalescent plasma for patients with Corona SARS in Hong Kong. Passive immunization using hyper immunoglobulin preparations against measles as well as early treatment was proven effective when compared to no intervention conservative approach . A recent publication encourages the use of COVID19 convalescent serum for the preparation of hyper immunoglobulins to be used for passive immunization as well as treatment of early disease before the development of lower respiratory tract disease; pneumonia.
Provision of Convalescent COVID19 hyper immunoglobulin:
This can be achieved through one of the following three approaches:
Fist approach: Convalescent COVID19 immunoglobulins can be obtained by transfusion of 1 - 4 units of COVID19 FFP for passive immunization or treatment of early disease. The advantages of this approach is that it is easy to prepare such units of FFP through regular blood banks. Disadvantages include variability of existence and levels of neutralizing COVID19 immunoglobulins in individual plasma units. This may result in variability of effectiveness for such an approach for prevention and treatment. Risk of transfusion transmitted infections as well as immunological adverse events due to infusion of large volume of FFP are among other disadvantages of using individual FFP units.
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
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a. Passive immunization group (Group A)
- •20 high risk exposed persons (HCPs) who are nasopharyngeal swab SARSCoV-2 PCR negative and seronegative for SARS-CoV-2 IgM/IgG antibodies to receive prophylactic anti- SARS-CoV-2 hyper immunoglobulin. Selected population can be both male and female with age range 21 - 50 years b. 20 high risk persons (HCPs) who are nasopharyngeal swab SARS-CoV-2 PCR negative and seronegative for SARS-CoV-2 IgM/IgG antibodies as control group. Selected population can be both male and female with age range 21 - 50 years
- •Patient group (group B):
- •a. 30 patients with COVID19 disease and nasopharyngeal swab or sputum SARSCoV-2 positive PCR to receive anti-SARS-CoV-2 in addition to applied clinical management protocol. Selected test group can be male or female with age >20 years b. 30 patients with COVID-19 disease and nasopharyngeal swab or sputum SARS-CoV-2 PCR positive managed according to applied clinical management protocols of COVID-19 disease as control group. Selected test group can be male or female with age >30 years
排除标准
- •Passive immunization group (Group A):
- •Age less than 21 or above 50 years
- •. Nasopharyngeal swab SARS-CoV-2 positive PCR
- •. Presence of anti-SARS-CoV-2 IgM, IgG
- •Presence of comorbidities such as hypertension, diabetes, chronic renal disease, previous thrombotic events or states of allergy such as urticaria or bronchial asthma as well as previous adverse events due to infusion of IVIG
- •Patient group (group B):
- •Age less than 20 years
- •. SARS-CoV-2 PCR negative
- •. COVID-19 patients who may suffer from co morbidities such as hypertension, diabetes, chronic renal disease, thrombotic tendency or history of adverse events to IVIG as well as old age will be excluded to reduce the possibility of development of serious adverse events related to infusion of IVIG unless it will be for compassionate use in advanced stages of COVID-19 patients and after obtaining informed consent
研究组 & 干预措施
Hyper immunoglobulins have anti-Corona VS2 immunoglobulin
safe purified hyper immunoglobulins containing anti-Corona VS2 immunoglobulins from plasma collected from COVID19 convalescent patients
干预措施: hyper immunoglobulins containing anti-Corona VS2 immunoglobulin (Other)
结局指标
主要结局
Efficacy of COVID19 hyper immunoglobulins for patients
时间窗: 2 weeks
efficacy of COVID19 hyper immunoglobulins prepared from convalescent plasma using VIPS Mini-Pool IVIG medical device in the treatment of COVID19
Efficacy of COVID19 hyper immunoglobulins for high risk groups
时间窗: 1 month
efficacy of anti-SARS-CoV-2 hyper immunoglobulins in the prevention of infection in high risk groups exposed to SARS-CoV-2 infection
Safety of anti-SARS-CoV-2 hyper immunoglobulins assessed by percentage of adverse events
时间窗: 72 hours
overall percentage of adverse events as hemolysis and anaphylaxis ,headache and other complains that occur during 72 hours of following infusion of anti-SARS-CoV-2 hyper immunoglobulins will be assessed by 1-vital sign 2-hemolysis by LDH and bilirubin level
次要结局
未报告次要终点
研究者
Alshaimaa Mokhtar Selim mohamed
principal investigator
Assiut University