NCT04456452已完成1 期
A Randomized Controlled Trial to Evaluate the Safety of Intravenous Ampion™ in Adult COVID-19 Patients Requiring Oxygen Supplementation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of IV Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who require supplemental oxygen.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years to 89 years old (inclusive).
- •Hospitalized and diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-COV-
- •Patient is receiving supplemental oxygen (e.g. oxygen saturation (SpO2) <88%, labored breathing, increased respiratory rate, dyspnea on rest or exertion).
- •A signed informed consent form from the patient or the patient's legal representative must be available.
排除标准
- •In the opinion of the clinical team, progression to death is imminent and inevitable, irrespective of the provision of treatments.
- •Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
- •Patient is on chronic immunosuppressive medication.
- •As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
- •A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
- •Patient has known pregnancy or is currently breastfeeding.
- •Participation in another clinical trial.
- •Baseline QT prolongation.
结局指标
主要结局
Incidence and severity of adverse events
时间窗: Primary endpoint at day 5
Incidence and severity of adverse events
次要结局
未报告次要终点
研究者
研究点 (2)
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