NCT04606784已完成1 期
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Nebulized Ampion In Adults With Respiratory Distress Secondary to COVID-19 Infection
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 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 nebulized Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who have respiratory distress.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, ≥ 18 years old.
- •Diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-CoV-2, or suspected COVID-19 diagnosis based on radiological clinical findings.
- •Respiratory distress as evidenced by at least two of the following:
- •Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.)
- •Recording of SpO2 ≤ 90% or the patient is requiring supplemental oxygen to maintain an SpO2 ≥ 90%
- •Requiring supplemental oxygen
- •Diagnosis of mild, moderate, or severe ARDS by Berlin definition
- •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 within the next 24 hours, irrespective of the provision of treatments.
- •Patient has a do-not-resuscitate (DNR) or do-not-intubate (DNI) order in place
- •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 (not including treatments for COVID-19 as approved by the FDA through expanded access or compassionate use).
- •Baseline QT prolongation.
研究组 & 干预措施
Ampion
Experimental
Ampion
干预措施: Standard of Care (Other)
Standard of Care
Other
Standard of Care
干预措施: Standard of Care (Other)
Ampion
Experimental
Ampion
干预措施: Ampion (Biological)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: Day 28
Incidence and severity of adverse events
Incidence and severity of adverse events
时间窗: Day 5
Incidence and severity of adverse events
次要结局
- Clinical status using 8-point ordinal scale(Day 28)
- Clinical status using 8-point ordinal scale(Day 5)
研究者
研究点 (1)
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