NCT05352347招募中2 期
A Randomized, Double-blinded, Placebo-controlled, Parallel-treatment Group, Adaptive Design, Multi-center, Phase 2b/3 Trial to Evaluate Efficacy and Safety of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients
Shaperon1 个研究点 分布在 1 个国家目标入组 1,134 人开始时间: 2022年4月12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
- 招募中
- 发起方
- 入组人数
- 1,134
- 试验地点
- 1
- 主要终点
- Time to discharge relative to the first dosing date of the IMP (randomization date) [Phase 3]
研究概览
简要总结
A Randomized, Double-blinded, Placebo-controlled, Parallel-treatment Group, Adaptive Design, Multi-center, Phase 2b/3 Trial to Evaluate Efficacy and Safety of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An individual who or whose legally authorized representative has fully informed of all pertinent aspect of the trial and IMP, voluntarily decided to participate in the trial and adherence to the trial-related requirements, and provided a written informed consent
- •An adult man or woman aged between 19 years (or age of majority in his/her country) and 80 years.
- •A hospitalized patient with laboratory-confirmed SARS-CoV-2 infection by PCR test within 10 days (240 hours) prior to randomization.
- •At the time of randomization; whose clinical status is stage 4 (oxygenation by facial mask or nasal cannula) or 5 (non-invasive ventilation or high flow oxygen) on WHO 8-point ordinal scale
- •Pneumonia that satisfies all the following criteria at the time of randomization
- •Planned first dosing of the IMP not later than 2 days after the initiation of standard of care (SOC), when given in combination with SOC for severe Illness (according to NIH Clinical Spectrum of SARS-CoV-2 Infection)
- •A score of 5 points or more ("think sepsis") on the NEWS 2 scale at the time of randomization
排除标准
- •A patient whose clinical status is stage 3 or lower on the WHO 8-point ordinal scale (WHO 8-OS) at the time of randomization
- •An individual who requires endotracheal intubation, mechanical ventilation (WHO 8-OS stage 6), or extracorporeal membrane oxygen therapy (stage 7) at the time of randomization
- •A patient with multiorgan failure, shock, acute respiratory syndrome (ARDS)
- •A patient with renal dysfunction defined by eGFR less than 30mL/min/1.73m², or the use of hemodialysis or hemofiltration
- •Cholestatic liver disease (example: biliary obstruction, cholangitis, etc.) or hepatic dysfunction
- •Any of the following laboratory test results at the time of screening:
- •An individual with HIV-positive results or who requires antiviral treatments against active hepatitis (HBV, HCV) and etc.
研究组 & 干预措施
NuSepin® 0.2 mg/kg
Active Comparator
NuSepin® 0.2 mg/kg in 100mL NS bid
干预措施: NuSepin® 0.2 mg/kg (Drug)
NuSepin® 0.4 mg/kg
Active Comparator
NuSepin® 0.4 mg/kg in 100mL NS bid
干预措施: NuSepin® 0.4 mg/kg (Drug)
Placebo
Placebo Comparator
Normal saline (NS) 100mL bid
干预措施: Placebo (Drug)
结局指标
主要结局
Time to discharge relative to the first dosing date of the IMP (randomization date) [Phase 3]
时间窗: Day 29
Time to improvement of at least 2 categories relative to the first dosing date of the Investigational Medicinal Product (randomization date) on an 8-point ordinal scale (WHO 8-point ordinal scale) of clinical status up to day 29 [Phase 2b]
时间窗: Day 29
次要结局
- WHO 8-point ordinal scale(Day 29)
- Compliance(Day 29)
- biomarkers(Day 29)
- Cytokine release syndrome(Day 29)
- Viral burden(Day 29)
- Safety Endpoints(Day 29)
- the use of ventilatory assistance(Day 29)
- NEWS 2(Day 29)
- Hospitalization and ICU Admission(Day 29)
- Survival(Day 29)
研究者
研究点 (1)
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