Course of Inflammation and Infection Markers in Critically Ill ICU Patients Under Casirivimab- and/or Tocilizumab Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Mortality rates in the 4 groups
研究概览
简要总结
In a retrospective observational study, critically ill COVID-19 patients admitted to the ICU with the CoV-2 delta-variant between august 2021 and february 2022 were evaluated (ethics application nr. 129/22 of the ethics commssion of the university Ulm.
详细描述
According to the recommendations, IgG seronegative SARSCoV2-Spike antibody (< 0,80 U/ml) COVID-19 patients were treated with 1 dose of subcutaneous casirivimab and imdevimab, 1200 mg (600 mg of each). Patients with CRP > 75 mg/l or IL-6 > 75 ng/l were treated with one dose of intravenous tocilizumab 8 mg/kg body weight. 28-day mortality and 30-day time course of leukocyte counts and serum concentrations of C-reactive protein (CRP), procalcitonin (PCT), interleukin 6 (IL-6) and ferritin in 4 patient groups, i. e., treated without (N) or with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T), were evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COVID-19
- •CoV-2 delta-variant
- •critically ill patients
排除标准
- •tuberculosis
- •active hepatitis
研究组 & 干预措施
C, treated with casirivimab / imdevimab
Active comparator
干预措施: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T) (Drug)
T, Treated with Tocilizumab
Active comparator
干预措施: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T) (Drug)
C + T, treated with casirivimab / imdevimab and tocilizumab
Active comparator
干预措施: treated without (N), with casirivimab / imdevimab (C) or tocilizumab (T), solely, or in combination of both (C + T) (Drug)
结局指标
主要结局
Mortality rates in the 4 groups
时间窗: 28-day mortality
Number of survivors and nonsurvivors
次要结局
- C-reactive protein in 4 groups(30-days)
- Ferritin serum concentrations in 4 groups(30-days)
- Leukocyte count in 4 groups(30-days)
- Interleukin 6 serum concentrations in 4 groups(30-days)
- Procalcitonin serum concentrations in 4 groups(30-days)
研究者
Manfred Weiss
Principal Investigator
University of Ulm