NCT04357860已完成2 期
Clinical Trial of Sarilumab in Adults Hospitalized With COVID-19 Presenting Cytokine Release Syndrome
Maimónides Biomedical Research Institute of Córdoba1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年4月28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
- 120
- 试验地点
- 1
- 主要终点
- Ventilation requirements
研究概览
简要总结
Early administration of sarilumab in hospitalized patients infected with COVID-19 who have pulmonary infiltrates and are at high risk of unfavorable evolution could decrease/prevent progression to acute respiratory distress syndrome (ARDS) requiring high flow nasal oxygenation (HFNO) or either invasive or non-invasive mechanical ventilation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and <75 years
- •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
- •Interstitial pneumonia confirmed by chest radiography or CT
- •IL-6 levels> 40 pg / ml. In its absence, D-Dimer (DD)> 1500 or> 1000 may be included if progressive increases are documented
- •Negative pregnancy test in women of childbearing age
- •Signature of informed consent
排除标准
- •SOFA score> 6 points
- •Patient who, in the researcher's opinion, is not a subsidiary of invasive mechanical ventilation
- •Neutrophil count <2 x 103 / μL
- •Platelet count <100 x 103 / μL
- •ALT or AST levels> 5 times the upper limit of normal
- •Severe renal failure (CrCr <30 ml / min)
- •Active bacterial infectious process
- •Active tuberculosis, history of not completing treatment against tuberculosis, suspicion of extrapulmonary tuberculosis
- •History of intestinal ulcer or diverticulitis
- •History of hypersensitivity reactions to Sarilumab or its excipients
- •Treatment with TNF antagonists
- •Previous treatment with anti-IL6 in the previous 30 days
- •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
- •Concomitant treatment with immunomodulators, among which are Vitamin D or statins. Macrolides such as azithromycin are acceptable
- •Patients on immunosuppressive treatment for any cause
- •HIV-infected patients with CD4 <200 / mm3
- •Past or current history of autoimmune disease or systemic inflammatory disease
- •Patients who have received or are planning therapy with immunomodulatory antibodies, including immunoglobulins
- •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
- •Pregnancy
- •Any other condition that, in clinical judgment, prevents adherence to the patient's protocol
研究组 & 干预措施
Sarilumab 200 mg
Experimental
Subjects treated with the best available treatment up to 14 days plus Sarilumab 200 mg single dose.
干预措施: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA] (Drug)
Sarilumab 400 mg
Experimental
Subjects treated with the best available treatment up to 14 days plus Sarilumab 400 mg single dose.
干预措施: Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] (Drug)
Control
Active Comparator
Subjects treated with the best available treatment up to 14 days.
干预措施: Best available treatment (Drug)
结局指标
主要结局
Ventilation requirements
时间窗: At day 28 or when the subject is discharged (whichever occurs first)
Proportion of patients requiring or time (in days) until required: * High flow nasal oxygenation (HFNO) * Non-invasive mechanical ventilation type BiPAP * Non-invasive mechanical ventilation type CPAP * Invasive mechanical ventilation
次要结局
- Time to clinical improvement(At day 28 or when the subject is discharged (whichever occurs first))
- Proportion of patients requiring invasive mechanical ventilation(At day 28 or when the subject is discharged (whichever occurs first))
- Crude mortality(At day 28 or when the subject is discharged (whichever occurs first))
- Time until improvement in oxygenation(At day 28 or when the subject is discharged (whichever occurs first))
- Proportion of patients having negative COVID-19 CRP at each visit(At day 28 or when the subject is discharged (whichever occurs first))
- Mean of serum cytokine levels(At day 28 or when the subject is discharged (whichever occurs first))
- Adverse events related to medication and its administration(At day 28 or when the subject is discharged (whichever occurs first))
- Incidence in the appearance of serious bacterial, fungal or opportunistic infections(At day 28 or when the subject is discharged (whichever occurs first))
- Incidence of perforation of the gastrointestinal tract(At day 28 or when the subject is discharged (whichever occurs first))
- Leukocyte and neutrophil count(At day 28 or when the subject is discharged (whichever occurs first))
- Hemoglobin levels(At day 28 or when the subject is discharged (whichever occurs first))
- Platelet count(At day 28 or when the subject is discharged (whichever occurs first))
- Levels of creatinemia(At day 28 or when the subject is discharged (whichever occurs first))
- Bilirubin levels(At day 28 or when the subject is discharged (whichever occurs first))
- ALT and AST levels(At day 28 or when the subject is discharged (whichever occurs first))
研究者
研究点 (1)
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