Personalized Targeted Immunomodulation in Patients With ARDS Related to COVID19 and Future Pandemic Pathogens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Erasmus Medical Center
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- Mortality up to day 90
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: 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).
Intervention: Standard of care (Drug)
Outcomes
Primary Outcomes
Mortality up to day 90
Time Frame: From date of ICU admission up to date of hospital discharge, assessed up to 90 days.
Change in SOFA score
Time Frame: 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
Time Frame: During the full course of ICU admission. The length of ICU-stays varies per patient.
Number of ventilator free days
Change in biomarker values
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Henrik Endeman
Henrik Endeman, MD, PhD
Erasmus Medical Center