NCT04400058已完成3 期
Efficacy and Safety of Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 207
- 试验地点
- 23
- 主要终点
- Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in patients with severe Coronavirus disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult aged ≥18years old
- •Provide voluntary, fully informed written and signed consent before any study-related procedures are conducted
- •Able to understand and comply with the relevant aspects of the study protocol
- •Laboratory (RT-PCR) confirmed COVID-19 infection on throat swab and/or sputum and/or lower respiratory tract samples
- •Hospitalized with a resting room-air SpO2 of ≤93% or PaO2/FiO2 ratio <300mmHg. Measurement can be taken from documented source records in the 24 hours prior to screening
- •Chest imaging confirming lung involvement
排除标准
- •Existence of other evidence that can explain pneumonia including but not limited to: Influenza A virus, influenza B virus, bacterial pneumonia (as suggested by the combined clinical picture, radiological findings and known laboratory results [eg, elevated procalcitonin >0.5ng/mL and concomitant neutrophilia]), known fungal pneumonia, suspected fungal pneumonia based on compromised immune system with a history of past fungal infections, noninfectious causes, etc.
- •Known history of serious allergic reactions, including anaphylaxis, to IVIG or its preparation components
- •Subjects with a history of thromboembolic event (TEE) within the last 12 months, such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease (Fontaine IV)
- •Subjects with an underlying medical condition that can lead to hypercoagulable states and hyperviscosity such as antithrombin III deficiency, Factor V Leiden, Protein C deficiency, antiphospholipid syndrome and malignancy
- •Known history of selective IgA deficiency with antibodies against IgA
- •Subjects with conditions such as human immunodeficiency virus (HIV) infection, known acute or chronic hepatitis B or C (HBsAg positive or HCV ribonucleic acid (RNA) PCR positive or currently treated with antivirals), pulmonary fibrosis, elevated procalcitonin (> 0.5) with concomitant neutrophilia (elevated polys), heparin induced thrombocytopenia (HIT), and moderate to severe renal dysfunction (per investigator discretion based on estimated glomerular filtration rate [eGFR] <59 mL/min/1.73 m2, as defined by KDIGO Clinical Practice Guideline):
- •Moderately reduced GFR (G3a): GFR = 45 to 59 ml/min/1.73 m2
- •Moderately reduced GFR (G3b): GFR = 30 to 44 ml/min/1.73 m2
- •Severely reduced GFR (G4): GFR = 15 to 29 ml/min/1.73 m2
- •Kidney failure (G5): GFR <15 ml/min/1.73 m2
- •Currently requiring IMV (invasive mechanical ventilation or having received IMV during the last 30 days
- •Known clinically significant preexisting lung, heart, or neuromuscular disease that, in the investigator's opinion, would impact subject's ability to complete study or may confound the study results
- •Body weight >125 kg
- •Women who are pregnant or breast-feeding
- •Subjects who received COVID-19 convalescent plasma, IVIG products, anti-interleukin agents (eg, Tocilizumab), or interferons for their COVID-19 disease before enrollment or plan to receive this treatment during the course of the study
- •Enrolled in other experimental interventional studies or taking experimental medications (ie, convalescent plasma). Diagnostic studies can be allowed if the anticipated total blood volume to be drawn across both studies and for therapeutic purposes does not exceed 450 mL over any 8-week period.
结局指标
主要结局
Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7
时间窗: 7 days
Proportion of subjects reaching stabilization or improvement in clinical status in at least one category on a 6-point clinical status scale. Clinical status categories will be defined as: 1. Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. no fever, respiratory rate, oxygen saturation return to normal, and cough relief). 2. Hospitalization, not requiring supplemental oxygen. 3. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). 4. ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient ≥150mmHg. 5. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. 6. Death.
次要结局
- Length of Hospital Stay (Time to Discharge)(33 days)
- ICU Stay Length(33 days)
- Number of Subjects With Severe Disease Progression(33 days)
- Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14(14 days)
- Cumulative Duration of Invasive Mechanical Venitlation (IMV)(33 days)
- Cumulative Mortality Rate Through Day 33(33 days)
研究者
研究点 (23)
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