NCT04642950已完成2 期
A Phase II/III Study of Sargramostim in Patients With Coronavirus Disease-2019 (COVID-19)
Nobelpharma7 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年12月17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
- 70
- 试验地点
- 7
- 主要终点
- 2-rank Improvement on a 7-point Ordinal Scale
研究概览
简要总结
This is a randomized, placebo-controlled, double-blind, group comparison, multicenter study to evaluate the efficacy and safety of inhalation administration of sargramostim for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment in COVID-19 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese male or female subjects who have been confirmed to meet all the following criteria.
- •Hospitalized patients under treatment who were severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] positive by polymerase chain reaction (PCR) test.
- •Patients with clinically diagnosed pneumonia and a percutaneous oxygen saturation [SpO2] of 93% or less on breathing of room air at bed rest.
- •Patients for whom written informed consent has been obtained from those themselves or the legally acceptable representatives.
- •Patients aged 20 years or older and younger than 85 years at the time of obtaining informed consent.
排除标准
- •Subjects who meet any of the following criteria will be excluded. Unless otherwise stated, the following criteria refer to those at the time of screening.
- •Patients who have been participating in other intervention studies, such as studies on unapproved pharmacotherapy, within 90 days prior to screening.
- •Patients who have experienced off-label use of approved drugs (including those for COVID-19 treatment other than steroids as standard treatment) within 7 days prior to screening.
- •Patients who are not expected to survive longer than 24 hours after commencement of study drug administration.
- •Patients who are using invasive ventilator or extracorporeal membrane oxygenation (ECMO).
- •Patients who have a chronic respiratory disease requiring continuous home oxygen therapy or ventilator use.
- •Patients with an underlying condition that is considered very unlikely to withdraw ventilator (e.g., motor neuron disease, Duchenne muscular dystrophy, rapidly progressive interstitial pulmonary fibrosis).
- •Patients who have a disease including bronchial asthma, lower respiratory tract infections, and interstitial lung diseases that may affect the assessment of the clinical study, since before the symptom onset of COVID-
- •Patients who have a disease including leukemia and leukocytosis that causes leukocytosis.
- •Patients who have a chronic kidney disease requiring dialysis.
- •Patients who have severe liver failure (Child Pugh grade C).
- •Patients aged 80 years or older with any of heart failure, cerebrovascular disease, obesity (BMI 30 or higher), dyslipidemia, hypertension or diabetes.
研究组 & 干预措施
NPC-26
Experimental
Sargramostim (125 μg) will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment.
干预措施: Sargramostim (Drug)
NP-26 Placebo
Placebo Comparator
Physiological saline will be administered by inhalation twice daily for 5 days, in principle (up to 10 days) as Add-on treatment to the standard treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
2-rank Improvement on a 7-point Ordinal Scale
时间窗: Period until Day 28 (including the case after discharge).
Number of days to achieve at least 2-rank improvement on a 7-point ordinal scale from baseline until Day 28.
次要结局
- Changes From Baseline in Alveolar-arterial Oxygen Partial Pressure Gradient (A-aDO)(Period until Day 28 (including the case after discharge).)
- Number of Days Until Discharge From Baseline(Period until Day 28 (including the case after discharge).)
- Proportion of Subjects Whose Category Has Shifted to Category 1 or 2(Period until Day 28 (including the case after discharge).)
研究者
研究点 (7)
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