EUCTR2020-001870-32-DE进行中（未招募）1 期
Phase 2, randomized, controlled, open label multi-center study to assess efficacy and safety of DFV890 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients aged 18-80 years inclusive at screening
- •Clinically diagnosed with the SARS-CoV-2 virus
- •Hospitalized with COVID-19-induced pneumonia evidenced by chest Xray, computed tomography scan (CT scan) or magnetic resonance scan (MR scan), taken within 5 days prior to randomization (within 24 hours
- •for patients in the Netherlands)
- •Impaired respiratory function, defined as peripheral oxygen saturation (SpO2) =93% on room air or partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) <300 millimeter of mercury (mmHg) at screening. For cities located at altitudes greater than 2500 m above sea level, these will be substituted with SpO2 <90% and PaO2/FiO2 <250 mmHg
- •APACHE II score of =10 at time of randomization
- •C-reactive protein (CRP) =20 mg/L and/or ferritin level =600 µg/L
- •Body weight mass index of =18 to <40kg/m2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Suspected active or chronic bacterial (including Mycobacterium tuberculosis), fungal, viral, or other infection (besides SARS-CoV-2)
- •In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
- •Intubated prior to randomization
- •Previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs, with the exception of hydroxychloroquine, chloroquine or corticosteroids
- •For COVID-19 infection, ongoing corticosteroid treatment is permitted at doses as per local SoC
- •For non-COVID-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and
- •including prednisolone 10 mg daily or equivalent.
- •In patients in the Netherlands only, the use of hydroxychloroquine and/or chloroquine in the
- •past 2 weeks are exclusionary.
- •Serum alanine transaminase (ALT) or aspartate transaminase (AST) >5 times upper limit of normal detected within 24 hours at screening or at baseline or other evidence of severe hepatic impairment (Child-Pugh Class C)
- •Absolute peripheral blood neutrophil count of =1000/mm3
- •Estimated glomerular filtration rate (eGFR) =30 mL/min/1.73m2
- •Patients currently being treated with drugs known to be strong or moderate inducers of isoenzyme CYP2C9 and/or strong inhibitors of CYP2C9 and/or strong inducers of cytochrome P450, family 3, subfamily A (CYP3A) and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment
- •Patients with innate or acquired immunodeficiencies
- •Patients who have undergone solid organ or stem cell transplantation
研究者
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