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Completed

NCT Number: NCT06311448

Personalized Targeted Immunomodulation in COVID-19 ARDS

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.

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Key information

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus Medical Centre

Rotterdam, South Holland, 3015 GD, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single target immunomodulation

Drug

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.

Standard of care

Drug

Standard of care during COVID-19 pandemic including steroids.

Primary outcomes

  1. Mortality up to day 90

    Time frame: From date of ICU admission up to date of hospital discharge, assessed up to 90 days.

  2. 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.

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Amsterdam UMC
  • Leiden University Medical Center
  • St. Antonius Hospital

Registry information

Official study title

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

Acronym: COMODULATE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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