EUCTR2020-001745-40-IT进行中（未招募）1 期
PILOT STUDY ON THE USE OF SARILUMAB IN PATIENTS WITH COVID-19 INFECTION - COVID-SARI-001
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •Age = 18 years and < 85 years.
- •Documented (chest X-Ray or TC scan), severe (BCRSS =3 and <4) interstitial pneumonia with respiratory failure (requiring supplemental oxygen) with positive Covid-19 swab testing.
- •Worsening of respiratory exchanges such as to require ventilation with Venturi mask >31% (6L/minute).
- •Increased levels of D-dimer (> 1500 ng/mL) or D-dimer progressively increasing (over 3 consecutive measurements) and reaching = 1000 ng/mL.
- •Signed informed consent
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Age < 18 years or = 85 years.
- •AST / ALT > 5x ULN.
- •Neutrophil count lower than 500 cells / mL.
- •PTL count lower than 50,000 cells / mL.
- •Documented sepsis due to infections other than Covid-19.
- •Presence of serious co-morbidities (such as COPD, diabetes, or cardiomyopathies) likely to cause, according to the clinical judgment, an unfavorable outcome.
- •Complicated diverticulitis or intestinal perforation.
- •Immunosuppressive therapy due to organ transplant.
研究者
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