EUCTR2020-001275-32-DK进行中（未招募）1 期
Effectiveness of Interleukin-6 Receptor Inhibitors in the Management of Patients with Severe SARS-CoV-2 Pneumonia: An Open-Label Multicenter Sequential Randomized Controlled Trial
The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark0 个研究点目标入组 200 人开始时间: 2020年3月24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
- 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
- •- SARS-CoV-2 infection confirmed by real time-PCR
- •- Positive imaging: consolidation, ground glass opacities, or bilateral pulmonary infiltration either by CT-scan or chest x-ray;
- •- Need of oxygen therapy to maintain SO2>94% OR FiO2/PaO2 < 22
- •- and at least two of the following laboratory parameters:
- •* CRP level >70 mg/L or CRP level >= 40 mg/L and doubled within 48 hours (without other confirmed infectious or non-infectious course),
- •* Lactatdehydrogenase > 250 U/L,
- •* thrombocytopenia < 120 x 10E9/L,
- •* lymphocyte count < 0.6 x 10E9/L,
- •* D-dimer > 1 ug/mL,
- •* serum ferritin > 300 ug/mL
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Age <18 years, pregnancy suspected or confirmed, severe heart failure, suspected or confirmed bacterial infection, current solid or haematological malignancy, neutropenia, ALAT elevation more than three times the laboratory upper limit, ASA class 5 (after COVID19 admission) or higher at inclusion (prior admission), severe chronic obstructive pulmonary disease or heart failure (NYHA class II or higher), current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents including IL-6 inhibitors, or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period, current use of chronic oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, previous or active tuberculosis (TB), HIV infection regardless of immunological status, hepatitis, evidence of recent (30 days) invasive bacterial or fungal infections, patients who have received immunosuppressive antibody therapy within the past 5 months, including intravenous immunoglobulin or plans to receive during the study period, IV drug abuse, history of inflammatory bowel disease, diverticulitis, ulcer, perforated gastrointestinal tract, participation in any clinical research study evaluating an investigational product (IP) or therapy within 3 months and less than five half-lives of IP prior inclusion to the study, any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study, inability to give informed consent.
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