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Clinical Trials/NCT06311448
NCT06311448CompletedNot Applicable

Personalized Targeted Immunomodulation in Patients With ARDS Related to COVID19 and Future Pandemic Pathogens

Erasmus Medical Center1 site in 1 country164 target enrollmentStarted: March 2, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Henrik Endeman

Henrik Endeman, MD, PhD

Erasmus Medical Center

Study Sites (1)

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