Clinical trial NCT06311448: Personalized Targeted Immunomodulation in COVID-19 ARDS
Official title: Personalized Targeted Immunomodulation in Patients With ARDS Related to COVID19 and Future Pandemic Pathogens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Keywords: Immunomodulation
Tociluzimab
Biomarker
Complement inhibitors
IL-6 inhibitors
IL-1 inhibitors
JAK inhibitors
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC
name: Leiden University Medical Center
name: St. Antonius Hospital
First posted: 2024-03-15
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: Mortality up to day 90
timeFrame: From date of ICU admission up to date of hospital discharge, assessed up to 90 days.
measure: Change in SOFA score
timeFrame: During the full course of ICU-admission. The length of ICU-stays varies per patient.
measure: Ventilator free days
timeFrame: During the full course of ICU admission. The length of ICU-stays varies per patient.
measure: Change in biomarker values
timeFrame: During the full course of ICU admission. The length of ICU-stays varies per patient.
measure: Costs of immmunomodulation
timeFrame: During the full course of ICU admission. The length of ICU-stays varies per patient.
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Centre
name: H. Endeman, Dr.
role: PRINCIPAL_INVESTIGATOR
References: