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| Name | Class |
|---|---|
| Amsterdam UMC | OTHER |
| Leiden University Medical Center | OTHER |
| St. Antonius Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single target immunomodulation | Drug | Single target immunomodulation compromise of drugs which very specifically target cytokines, chemokines or specific receptors, which are involved in the pathofysiology of COVID-19. For instance, tociluzimab (IL-6 receptor blocker), Anakinra (IL-1 receptor blocker), Eculizimab (Complement inhibitor C5), etc. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality up to day 90 | From date of ICU admission up to date of hospital discharge, assessed up to 90 days. | |
| Change in SOFA score | 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. | During the full course of ICU-admission. The length of ICU-stays varies per patient. |
| Ventilator free days | Number of ventilator free days | During the full course of ICU admission. The length of ICU-stays varies per patient. |
| Change in biomarker values | 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. | During the full course of ICU admission. The length of ICU-stays varies per patient. |
| Costs of immmunomodulation | 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. | During the full course of ICU admission. The length of ICU-stays varies per patient. |
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Inclusion Criteria:
Exclusion Criteria:
- Refusing participation
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Adults aged 18 years or older, admitted to the ICU due to COVID-induced moderate or severe ARDS as defined by the Berlin criteria, and requiring mechanical ventilation, were eligible for study participation.
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| Name | Affiliation | Role |
|---|---|---|
| H. Endeman, Dr. | Erasmus Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Centre | Rotterdam | South Holland | 3015 GD | Netherlands |
Data will be made available through a secure data transfer system and appropriate data transfer agreement. (The data set contains personal data.
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Drug | Standard of care during COVID-19 pandemic including steroids. |
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