Clinical trial
Personalized Targeted Immunomodulation in Patients With ARDS Related to COVID19 and Future Pandemic Pathogens
Name
10094
Description
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.
Trial arms
Trial start
2020-03-02
Estimated PCD
2022-02-01
Trial end
2022-02-01
Status
Completed
Treatment
Single 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.
Arms:
Treated with immunomodulation
Standard of care
Standard of care during COVID-19 pandemic including steroids.
Arms:
Not treated with immunomodulation
Size
164
Primary endpoint
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.
Ventilator free days
During the full course of ICU admission. The length of ICU-stays varies per patient.
Change in biomarker values
During the full course of ICU admission. The length of ICU-stays varies per patient.
Costs of immmunomodulation
During the full course of ICU admission. The length of ICU-stays varies per patient.
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 164, 'type': 'ACTUAL'}}
Updated at
2024-03-15
1 organization
2 products
1 indication
Organization
Erasmus Medical CenterIndication
COVID-19 ARDSProduct
Standard of care