EUCTR2020-001531-27-ES进行中（未招募）1 期
Clinical trial of Sarilumab in adults hospitalized with COVID-19 presenting cytokine release syndrome
Fundación para la Investigación Biomédica de Córdoba0 个研究点目标入组 120 人开始时间: 2020年4月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- •1. Age = 18 years and <75 years
- •2. Admission for confirmed respiratory symptoms to COVID-19 based on a positive PCR in a sample of the respiratory tract in the local laboratory in the absence of respiratory distress syndrome requiring ONAF or mechanical ventilation
- •3. Interstitial pneumonia confirmed by chest radiography or CT
- •4. IL-6 levels> 40 pg / ml. In its absence, D-Dimer (DD)> 1500 or> 1000 may be included if progressive increases are documented
- •5. Negative pregnancy test in women of childbearing age
- •6. Signature of 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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. SOFA score> 6 points
- •2. Patient who, in the researcher's opinion, is not a subsidiary of invasive mechanical ventilation
- •3. Neutrophil count <2 x 103 / µL
- •4. Platelet count <100 x 103 / µL
- •5. ALT or AST levels> 5 times the upper limit of normal
- •6. Severe renal failure (CrCr <30 ml / min)
- •7. Active bacterial infectious process
- •8. Active tuberculosis, history of not completing treatment against tuberculosis, suspicion of extrapulmonary tuberculosis
- •9. History of intestinal ulcer or diverticulitis
- •10. History of hypersensitivity reactions to Sarilumab or its excipients
- •11. Treatment with TNF antagonists
- •13. Previous treatment with anti-IL6 in the previous 30 days
- •14. Chronic prior treatment with corticosteroids at doses greater than 0.5 mg / kg / day of prednisone or equivalent. Yes, inhaled and topical corticosteroids are acceptable
- •15. Concomitant treatment with immunomodulators, among which are Vitamin D or statins. Macrolides such as azithromycin are acceptable
- •16. Patients on immunosuppressive treatment for any cause
- •17. HIV-infected patients with CD4 <200 / mm3
- •18. Past or current history of autoimmune disease or systemic inflammatory disease
- •19. Patients who have received or are planning therapy with immunomodulatory antibodies, including immunoglobulins
- •20. Participation in any clinical trial that evaluated any investigational product in the last 3 months or less than 5 half-lives of the investigational product
- •21. Pregnancy
- •22. Any other condition that, in clinical judgment, prevents adherence to the patient's protocol
研究者
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