EUCTR2020-001255-40-ES进行中（未招募）1 期
Sarilumab Treatment In cytoKinE storm caused by infection with COVID-19.
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
- 65
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.Written informed consent prior to performing study procedures. Oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
- •In the case of a vital emergency without the possibility of prior consent, a patient may be included in the study if the recommendations of the legislation are followed (RD 1090/2015, article 7), as stated in section 10.3 of the protocol.
- •2.Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
- •3.Negative pregnancy test in case of fertile women*
- •4.Greater than or equal to 18 years old
- •5.Infection by COVID-19 confirmed by rtPCR or other validated tests
- •6.Hospitalized (or documentation of a plan to admit to the hospital if the patient is in the emergency department) with illness of any duration, with evidence of pneumonia, and severe disease as defined by at least one of the following:
- •a.High oxygen requirements (face mask with reservoir, non-invasive mechanical ventilation or high flow nasal cannula)
- •b.Lymphocytes < 0.8 x 109/L
- •c.Serum ferritin > 300ng/mL
- •d.Increased levels of D-dimer (> 1500 ng/mL) or D-dimer progressively increasing (over 3 consecutive measurements) and reaching = 1000 ng/mL.
- •e.CPR > 10 mg/dL, or increasing over 24 hours
- •* A woman is considered fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Hypersensitivity to the active substance or any of the excipients listed in section 6 of the protocol
- •2.Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days
- •3.Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline
- •4.Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.
- •5.Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline
- •6.Tumor necrosis factor (TNF) inhibitors within 2-8 weeks (etanercept within 2 weeks, infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or after at least 5 half-lives have elapsed, whichever is longer.
- •7.Intravenous immunoglobulin (IVIG) within the past 5 months or plans to receive during the study period
- •8.Current use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day
- •9.Current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents
- •10.Patients who have received immunosuppressive antibody therapy within the past 5 months, including intravenous immunoglobulin
- •11.AST/ALT values > 5 x normal.
- •12.Neutropenia (< 0.5 x 109/L).
- •13.Sever thrombocytopenia (< 50 x 109/L).
- •14.Sepsis caused by an alternative pathogen.
- •15.Diverticulitis with risk of perforation.
- •16.Ongoing infectious dermatitis.
- •17.Patients with another active infection, including localized infections.
- •18.Pregnant or breast-feeding females will be excluded
- •19.Positive serology for following infection: HIV, Hepatitis B, or C.
研究者
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