EUCTR2020-002037-15-ES进行中（未招募）1 期
Multicenter, randomized, open-label study to evaluate the efficacy and safety of SOC + Sarilumab versus Standard of Care for the Early Treatment of COVID-19-pneumonia in Hospitalized Patients
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •Inclusion Criteria
- •1.Patients willing to provide written informed consent to participate in this study. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
- •2.The patient is at least 18 years of age.
- •3.The patient is positive for novel coronavirus by real-time RT-PCR
- •4.The patient is hospitalized for COVID-19 without either mechanical ventilation (invasive or non-invasive) or oxygen mask with reservoir bag and at least one of the following:
- •-Radiographic evidence of pulmonary infiltrates by imaging (chest x-ray, CT scan, etc.), OR clinical assessment (evidence of rales/crackles on exam)
- •- AND SpO2 = 94% on room air that requires supplemental oxygen.
- •5.More than 7 days between the onset of symptoms (fever, dysnea, and/or cough) and treatment administration day. In the absence of fever, cough, or dyspnea, other symptoms like asthenia, headache, or gastrointestinal symptoms may be considered
- •6.The patients presents progressive elevation of inflammatory parameters suggestive of a hyperinflammatory syndrome:
- •Presence of elevated IL-6 (>40pg/ml)
- •Elevated d-dimer (>1.0 mcg/ml), or alternatively, progressive worsening in at least two of these inflammatory parameters in the prior 48h: CRP, LDH, serum ferritin, lymphopenia, or d-dimer.
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Exclusion Criteria
- •1.Requiring mechanical ventilation (invasive or non-invasive) or oxygen mask with reservoir bag at screening.
- •2.Participation in any other clinical trial of an experimental treatment for COVID-19.
- •3.In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- •4.Any incompatibility or allergy to the administration of sarilumab or corticosteroids.
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