Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) Antibodies Based Intravenous Immunoglobulin (IVIG) Therapy for Severe and Critically Ill COVID-19 Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Adverse events during hospital stay
研究概览
简要总结
Severe and critically ill patients will be enrolled in the study (50 patients) after duly filled consent forms. Recipients shall be divided in to 5 groups with 10 patients per group to compare clinical efficacy and safety of patients in clinical phase I/phase II study. Each group shall receive particular single dose of Intravenously administered Immunoglobulins (IVIG) developed from convalescent plasma of recovered COVID-19 individual , an experimental drug along with standard treatment except for control group which will receive standard treatment only.
详细描述
Passive immunization using intravenous immunoglobulins (IVIG) has been tested for treating previous viral outbreaks and holds the potential to save lives in the current crisis. Recently researchers from China reported satisfactory recovery of critically ill Corona Virus Disease 2019 (COVID 19) patients when high dose intravenous immunoglobulin (IVIG) were administered.
Research team at Dow University of Health Sciences has purified immunoglobulin (both SARS-CoV 2 antibodies and existing antibodies) from convalescent plasma of COVID19 individuals and pooled to prepared IVIG formulation to treat severe and critically ill COVID-19 patients. To evaluate safety of the formulation animal (rats) safety trials and survival of all the animals were observed.
It is intended to assess safety and efficacy of experimental the IVIG treatment in severe and critically ill COVID 19 patients through phase I/phase II randomized single blinded clinical trial with fifty study participants. FDA outlined criteria for passive immunization using convalescent plasma, which will be used for recruiting participants in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above 18 years of age
- •Have positive SARS-CoV-2 PCR on nasopharyngeal and/or oropharyngeal swabs
- •Admitted in isolation ward and ICU of institutes affiliated with DUHS
- •have severe or critical COVID 19 as judged by the treating physician
- •Consent given by the patient or first degree relative
排除标准
- •Pregnancy
- •Previous allergic reaction to immunoglobulin treatment
- •Ig A deficiency
- •Patient requiring 2 inotropic agents to maintain blood pressures
- •Known case of any autoimmune disorder
- •Acute kidney injury or chronic renal failure
- •Known case of thromboembolic disorder
- •Aseptic meningitis
结局指标
主要结局
Adverse events during hospital stay
时间窗: 28 days
Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)
Requirement of supplemental oxygen support
时间窗: 28 days
Number of days required for invasive or non-invasive oxygen supply during hospital stay as per oxygen saturation status of patient
Change in neutrophil lymphocyte ratio
时间窗: 28 days
change in neutrophil lymphocyte ratio from baseline will be used to monitor inflammation
Number of days on assisted ventilation
时间窗: 28 days
Number of days a participant will be requiring assisted ventilation both invasive and noninvasive
Days to Hospital Discharge
时间窗: 28 days
Duration from day of enrollment in study to Day of hospital discharge
28 Days mortality
时间窗: 28 days
All cause mortality of participants will be monitored for 28 days to assess the safety and efficacy of IVIG treatment.
Days to step down
时间窗: 28 days
Shifting from ICU to ward
Change in C-Reactive Protein (CRP) levels
时间窗: 28 days
Change in C-Reactive Protein (CRP) levels from baseline will be used to monitor inflammation
次要结局
- Change in radiological (X-ray) findings(28 days)
- Change in Sodium levels(28 days)
- Change in Chloride levels(28 days)
- Change in fever(28 days)
- Change in Ferritin levels(28 days)
- Days to negative SARS-CoV-2 Polymerase Chain Reaction (PCR) test(28 days)
- Anti-SARS-CoV-2 Antibody(28 days)
- Change in Potassium levels(28 days)
- Change in Bicarbonate levels(28 days)
- Change in lactate dehydrogenase (LDH) levels(28 days)