Phase II/III Clinical Trial Study to Evaluate Efficacy and Safety of Anti COVID 19 Intravenous Immunoglobulin (C-IVIG) Therapy for Severe COVID-19 Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- 28 day Mortality
研究概览
简要总结
Severe ill Patients will be enrolled in the study (n=310) after duly filled consent forms. Recipients will be divided into 2 group, each group contain 155 patients to compare Safety and efficacy of patients in Clinical Trial phase II/III. One Group will receive 0.15g/kg single dose of anti COVID 19 intravenously immunoglobulin (C-IVIG) develop from convalescent plasma of recovered patients from COVID 19, along with Standard of care. The Comparator group will only receive standard of Care
详细描述
The 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 it to prepare IVIG formulation to treat severe and critically ill COVID-19 patients. Phase I/II trial was completed and showed potential safety and efficacy of the drug Anti COVID-19 intravenous immunoglobulin (C-IVIG) in severe and critical patients with COVID-19.
This trial's aim is to investigate the safety and efficacy of passive immunization in severe COVID-19 patients in phase II/III. The trial will be a randomized, single-blinded, superiority trial, through parallel-group design. The participant will either receive C-IVIG with Standard of care or receive only Standard of care. The study will consist of 310 participants of which 155 will receive a single dose of C-IVIG (0.15g/kg) with the standard of care and 155 will receive only the standard of care. Standard of care is standard hospital care which includes airway support, anti-viral medication, antibiotics, fluid resuscitation, hemodynamic support, steroids, painkillers, and antipyretics.
Randomized test patients will receive a single dose of C-IVIG in the following two dosage groups:
Group 1 (Test): Severe COVID-19 patients: Single dose of 0.15g/Kg with standard hospital care
Group 2 (Comparator): Severe COVID-19 patients: only standard hospital care only
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 COVID PCR on nasopharyngeal and/or oropharyngeal swabs
- •classified as severe* COVID-19 according to WHO guideline (5L-15L of oxygen requirement on FM, NRM)
- •Consent given by the patient or first degree relative
排除标准
- •Critical COVID-19 patients [ non-invasive ventilation (HFNC, BiPAP, CPAP) and invasive ventilation],
- •Pregnant females
- •Previous allergic reaction to immunoglobulin treatment
- •Known case of any autoimmune disorder
- •Chronic kidney disease
- •Known case of thromboembolic disorder
- •Aseptic meningitis
结局指标
主要结局
28 day Mortality
时间窗: 28 days
All cause mortality of participants will be monitored for 28 days to asses the safety and efficacy of C-IVIG
次要结局
- change in interleukin 6 (IL-6)(5 days)
- Immediate and serious adverse event during hospital Stay(28 days)
- change in C-Reactive Protein (CRP) levels(5 Days)
- Clinical Status of follow-up days according to 7-Catergory Ordinal Scale(28 days)
- change in radiological findings(5 days)
- change in anti-SARS-CoV-2 antibody levels(5 days)
- change in Horowitz idex(28 days)