Pilot Study of the Use of IVIG in Patients With Severe COVID-19 Infections Requiring Mechanical Ventilation and to Assess Their Biological Responses to IVIG Therapy
试验速览
- 阶段
- 4 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Hospital length of stay
研究概览
简要总结
The purpose of this Pilot Study is to establish a hypothesis of whether or not intravenous immunoglobulin (IVIG) may impact the hospital length of stay, if started within 48 of mechanical ventilation in patients infected with SARS-CoV-2 virus.
详细描述
This is an investigator initiated, open label, 1 arm study to observe the impact of length of hospitalization by starting IVIG administration within 48 hours of mechanical ventilation. The exploratory objective is to analyze the blood before, during and after IVIG administration. The blood will be analyzed for the production of inflammatory and non-inflammatory cytokines, biomarkers for endothelial injury and biomarkers for coagulation via Mass Spectrometry.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed COVID-19 positive test result
- •Initiation of the first dose of IVIG within 72 hours of mechanical ventilation.
- •Age >18 years old.
- •Consenting next of kin having access to an electronic device that is able to access DocuSign® online and email for consenting.
- •Subjects or their proxy must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
排除标准
- •Superimposed bacterial pneumonia or bacteremia
- •Severe allergy to any IVIG product formulation
- •Hypersensitivity to corn
- •Uncontrolled hypertension (SBP>180 mm Hg or DBP>120mmHg)
- •Active participant in another research treatment study
- •Advanced dementia
- •Severe renal disease (CrCl< 20 mL/min)
- •Active cancer malignancy
- •Active treatment with cancer chemotherapy or immunotherapy
- •Congestive heart failure clinically or by history (EF< 25%)
- •Prior receipt during admission of any other investigational agent (eg. convalescent plasma, tocilizumab)
- •Venous or arterial thrombosis < 90 days prior
- •Are receiving cytotoxic or biologic treatments such as TNF inhibitors, anti-interleukin-1 (IL-1), anti-IL-6 (tocilizumab or sarilumab), T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening, with the following exceptions:
- •B-cell targeted therapies: a washout period of 24 weeks or 5 half-lives (whichever is longer)
- •TNF inhibitors: a washout period of 2 weeks or 5 half-lives (whichever is longer), and
- •JAK inhibitor: a washout period of 1 week or 5 half-lives (whichever is longer).
研究组 & 干预措施
IVIG
IVIG 0.5gram/kg IVPB using actual body weight daily x 4 days
干预措施: IVIG (Drug)
结局指标
主要结局
Hospital length of stay
时间窗: Up to 60 days
Assess hospital length of stay after mechanical ventilation
次要结局
- Human metabolome and proteome(Up to 60 days)
研究者
George Sakoulas, MD
Infectious Disease Specialist
Sharp HealthCare