NCT04577534已完成3 期
COVID-19: Salvage TOcilizumab as a Rescue Measure. Use of Tocilizumab in the Inflammatory Phase of COVID-19 / New Coronavirus Disease
Jarmo Oksi1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2020年8月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Clinical status at day 28
研究概览
简要总结
Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consaent obtained
- •hospitalized with COVID-19 disease
- •Age >/= 18 years
- •SARS CoV-2 NhO posit
- •Sp=2 </93% on ambient air or respiratory rate >30 /min
- •Any 2 of the 4: P-IL-6 > 2 x ULN / P-ferritin > 2 x ULN / P-FIDD >1.5 mg/l / P- CRP >40 mg/l without obvious presence of bacterial infection (normal values: P -IL-6 <5.9 ng/l; P-ferritin, men 30-400 mikrog/l, women 13-150 mikrog/l ; P-FIDD (Fibrin degradation products, D-dimer) <0.5 mg/l; P-CRP <10 mg/l)
排除标准
- •Known severe allergic reactions to monoclonal antibodies
- •Active confirmed tuberculosis with ongoing treatment or obvious tuberculosis or obvious other bacterial, fungal or viral infection (besides COVID-19)
- •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
- •Long-term oral anti-rejection or immunomodulatory drugs (including corticosteroids equivalent to methylprednison 15mg/day)
- •Pregnant or lactating women. If needed, exclusion of pregnancy should be performed by laboratory test (U-hCG-O).
- •Participating in other drug clinical trials
- •Absolute neutrophil count < 1 x10E9/l
- •Platelet count <50 x10E9/l
- •ALAT >10x ULN
研究组 & 干预措施
Tocilizumab (TCZ)
Experimental
Participants will receive one infusion of iv TCZ (according to weight of patient)
干预措施: iv Tocillizumab (TCZ) (Drug)
结局指标
主要结局
Clinical status at day 28
时间窗: day 28
(assessed using 7-category ordinal scale) 7 death 6 in ICU with ECMO/ mechanical ventilation 5 in ICU, no ECMO/ mechanical ventilation 4 in hospital, not ICU, needs supplementary oxygen 3 in hospital, not ICU, no supplementary oxygen 2 not in hospital, but not back to normal 1 not in hospital, back to normal
次要结局
- SAPS II(28 days)
- Mortality rate(28 days)
- Time to hospital discharge or "ready for discharge"(28 days)
- Incidence of ICU stay(28 days)
- Time to clinical failure(28 days)
- CCI(28 days)
- Incidence of mechanical and/or non-invasive ventilation(28 days)
- Organ failure free days to day 28(28 days)
- Duration of ICU stay(28 days)
- Time to clinical improvement(28 days)
- Time to decline of at least 2 categories(28 days)
- Number of ventilator-free days to day 28(28 days)
- APACHE II(28 days)
- SOFA 6(28 days)
- Duration of supplemental oxygen(28 days)
研究者
Jarmo Oksi
Head of Infectious Diseases
Turku University Hospital
研究点 (1)
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