COVID-19 Acute Respiratory Distress Syndrome
Conditions
Keywords
Immunomodulation, Tociluzimab, Biomarker, Complement inhibitors, IL-6 inhibitors, IL-1 inhibitors, JAK inhibitors
Brief summary
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.
Interventions
DRUGSingle target immunomodulation
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.
DRUGStandard of care
Standard of care during COVID-19 pandemic including steroids.
Sponsors
Amsterdam UMC
Leiden University Medical Center
St. Antonius Hospital
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Admitted to ICU due to COVID induced moderate or severe ARDS * Requiring mechanical ventilation
Exclusion criteria
\- Refusing participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | During the full course of ICU admission. The length of ICU-stays varies per patient. | Number of ventilator free days |
| Change in biomarker values | 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 | 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. |
Countries
Netherlands
Outcome results
None listed