NCT04335136已完成2 期
Recombinant Human Angiotensin-converting Enzyme 2 (rhACE2) as a Treatment for Patients With COVID-19
Apeiron Biologics22 个研究点 分布在 5 个国家目标入组 185 人开始时间: 2020年4月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 22
- 主要终点
- All Cause-death or Invasive Mechanical Ventilation
研究概览
简要总结
Recombinant human angotensin-converting enzyme 2 (rhACE2) as a treatment for patients with COVID-19 to block viral entry and decrease viral replication.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized male or female
- •Diagnosed to be COVID-19 POSITIV
- •Signed Inform Consent Form
排除标准
- •Any patient whose clinical condition is deteriorating rapidly
- •Known history of positive Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody
- •History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
- •Pregnant females as determined by positive serum or urine hCG test prior to dosing
- •Lung transplantation
- •Pre-existing renal failure, i.e. requiring renal replacement therapy with hemodialysis or peritoneal dialysis
- •There are other uncontrolled co-morbidities that increase the risks associated with the study drug administration, that are assessed by the medical expert team as unsuitable
- •Patient in clinical trials for COVID-19 within 30 days before ICF
- •Immunocompromised patients (chemotherapy, HIV, organ transplants, stem cell transplants)
研究组 & 干预措施
Group A (active) APN01
Active Comparator
Recombinant human angiotensin-converting enzyme 2 (rhACE2) - APN01
干预措施: RhACE2 APN01 (Drug)
Group B (placebo control)
Placebo Comparator
干预措施: Physiological saline solution (Drug)
结局指标
主要结局
All Cause-death or Invasive Mechanical Ventilation
时间窗: 28 days
The primary endpoint was a composite endpoint of all cause-death or invasive mechanical ventilation up to 28 days or hospital discharge.
次要结局
- Time to Death(28 days)
- Mortality(28 days)
- Number of Patients With Any Use of Invasive Mechanical Ventilation up to 28 Days or Hospital Discharge(Up to 28 days)
- C-reactive Protein Levels(Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study)
- D-Dimer(Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study)
- Log-transformed Levels of LDH(Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study)
- Lactate Dehydrogenase (LDH) Level(Day 5)
- Viral Ribonucleic Acid (RNA).(Day 1, Day 3, Day 5, Day 7, Day 14, and Day 28/End of study (EOS))
- Ventilator-free Days (VFD)(28 days)
- Time to Hospital Discharge(Up to 28 days)
- Time to a 2-point Decrease in WHO's 11-Point Score System(Up to 28 days.)
- Lymphocyte Count(Day -1, Day 3, Day 7, Day 10, Day 14, Day 28/End of study)
- Number of Responders, Defined as ≥2 Improvement in World Health Organization (WHO)'s 11-Point Score System at Days 7, 10, 14 and 28(Day 7, Day 10, Day 14, Day 28)
- Modified Sequential Organ Failure Assessment Score (mSOFA Score, Total Score)(Day -1 (Screening), Day 7, Day 10, Day 14, Day 28/End of study)
- Time to First Use of Invasive Mechanical Ventilation up to 28 Days or Hospital Discharge(Up to 28 days)
- PaO2/FiO2 Value(Day 1, Day 7, Day 10, Day 14, and Day 28)
研究者
研究点 (22)
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