Personalized Targeted Immunomodulation in Patients With ARDS Related to COVID19 and Future Pandemic Pathogens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Mortality up to day 90
研究概览
简要总结
Rationale: In COVID19 single-targeted immunomodulation, mostly via an IL-6 receptor blocker, was used by a one-size fits all non-targeted approach. In future pandemics the same might occur. However, for individual patients, this might not yield optimal treatment.
Objectives: This project aims to identify a way to individualize and target immunomodulation, using COVID19 as a testcase for the future.
- Identify immunological pathways which are associated with outcome in C-ARDS.
- Test whether an individualized biomarker-based approach has an effect on outcome and costs when using single-target immunomodulation in C-ARDS(Tocilizumab, Anakinra, etc.).
- Explore whether other immunological pathways were present in patients with C-ARDS which could have been intervened with medication which is already available and has been described in ARDS or similar diseases.
Study type: Retrospective observational multicenter study in the Netherlands.
Study population: Adult patients (≥ 18 years) hospitalized and admitted to the ICU with COVID-19 and acute respiratory distress syndrome (ARDS) (i.e., receiving invasive mechanical ventilation) will be included.
Intervention (if applicable): Not applicable (retrospective study design).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Given the retrospective nature of the study, no burden, risks or benefits for the patient are associated with participation. The target population of this study is specific to hospitalized patients with COVID-19.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •At least 18 years of age
- •Admitted to ICU due to COVID induced moderate or severe ARDS
- •Requiring mechanical ventilation
排除标准
- •Refusing participation
研究组 & 干预措施
Treated with immunomodulation
Adult patients with COVID-19 ARDS admitted to ICU and requiring mechanical ventilation and receiving standard of care treatment (including steroids) and single-target immunomodulation, for example Toculizimab, Anakinra, etc.
干预措施: Single target immunomodulation (Drug)
Not treated with immunomodulation
Adult patients with COVID-19 ARDS admitted to ICU and requiring mechanical ventilation and receiving standard of care treatment (including steroids).
干预措施: Standard of care (Drug)
结局指标
主要结局
Mortality up to day 90
时间窗: From date of ICU admission up to date of hospital discharge, assessed up to 90 days.
Change in SOFA score
时间窗: During the full course of ICU-admission. The length of ICU-stays varies per patient.
Repeated measurements of SOFA scores during ICU admission will be performed on days 0, 1, 2, 7, 14, 21 and 28. SOFA scores will be compared between days and from the start to the end of ICU admission.
Ventilator free days
时间窗: During the full course of ICU admission. The length of ICU-stays varies per patient.
Number of ventilator free days
Change in biomarker values
时间窗: During the full course of ICU admission. The length of ICU-stays varies per patient.
Repeated measurements of biomarkers during ICU admission will be performed on days 0, 1, 2, 7, 14, 21 and 28. Biomarker values will be compared between days and from the start to the end of ICU-admission.
Costs of immmunomodulation
时间窗: During the full course of ICU admission. The length of ICU-stays varies per patient.
Costs of immunomodulation will be compared to the costs of dexamethason. Furthermore, we will explore whether patients who were treated with single target immunomodulation have shorter ICU length of stay and more ventilator free days, which also reduce the total costs.
次要结局
未报告次要终点
研究者
Henrik Endeman
Henrik Endeman, MD, PhD
Erasmus Medical Center