NCT04550325已完成1 期
A Phase 1/2 Open Label, Multicenter, Single Arm Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose Kamada Anti-SARS-CoV-2 in COVID-19 Hospitalized Patients With Pneumonia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Kamada, Ltd.
- 入组人数
- 12
- 试验地点
- 8
- 主要终点
- Adverse events, serious adverse events, and deaths
研究概览
简要总结
Evaluate the safety pharmacokinetics and pharmacodynamics (PK/PD)of a single dose of Kamada anti-severe acute respiratory syndrome (SARS)- CoV-2 in patients hospitalized with COVID-19 caused pneumonia
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
- •Age ≥ 18 years
- •Laboratory confirmed SARS-CoV-2 infection by nasopharyngeal swab Real time polymerase chain reaction (RT-PCR)
- •Hospitalized for COVID-19 pneumonia
- •Dosing should be within 10 days of symptom start
- •Able and willing to sign informed consent form
排除标准
- •History of hypersensitivity to plasma products and/or severe Immunoglobulin A deficiency (< 7 mg/dL)
- •Requirement of high flow oxygen devices, or non-invasive ventilation or mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at screening
- •Cardiovascular instability
- •History of thrombo-embolic events
- •Acute renal failure or creatinine >2 mg/dL or estimated estimated glomerular filtration rate (eGFR) <30 mL/min
- •History of lung transplantation
- •Major surgery (abdominal and chest) within the last 4 weeks
- •Severe chronic background disease, per investigator's judgement for example, Cirrhosis grade C, Dialysis, cardiac insufficiency (NYHA III), pulmonary disease (FEV1<50 percent of predicted) etc.
- •Pregnancy or lactation
- •Treatment with plasma units or immunoglobulin preparations within the last 4 weeks
- •Participation in another pharmaceutical interventional clinical study within 4 weeks from screening
结局指标
主要结局
Adverse events, serious adverse events, and deaths
时间窗: 28 days
Record adverse events, serious adverse events, and deaths
次要结局
- Neutralization activity(7 days)
- AUC0-7 of Anti SARS CoV-2 antibodies(7 days)
研究者
研究点 (8)
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