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Personalized Targeted Immunomodulation in COVID-19 ARDS

NCT06311448 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 164

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

  • COVID-19 Acute Respiratory Distress Syndrome

Interventions

DRUG

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.

DRUG

Standard of care

Standard of care during COVID-19 pandemic including steroids.

Sponsors & Collaborators

  • Amsterdam UMC

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • St. Antonius Hospital

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • H. Endeman, Dr. · Erasmus Medical Centre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-02
Primary Completion
2022-02-01
Completion
2022-02-01

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06311448 on ClinicalTrials.gov