Personalized Targeted Immunomodulation in COVID-19 ARDS

NCT06311448 | Completed

• 1 other identifier: 10094
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Keywords

Immunomodulation; Tociluzimab; Biomarker; Complement inhibitors; IL-6 inhibitors; IL-1 inhibitors; JAK inhibitors

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  During the full course of ICU-admission. The length of ICU-stays varies per patient.

• Ventilator free days

  Number of ventilator free days

  During the full course of ICU admission. The length of ICU-stays varies per patient.

• Change in biomarker values

  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.

  During the full course of ICU admission. The length of ICU-stays varies per patient.

• Costs of immmunomodulation

  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.

  During the full course of ICU admission. The length of ICU-stays varies per patient.

Study Arms (2)

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.

Drug: Single target immunomodulation

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).

Drug: Standard of care

Interventions

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.

Treated with immunomodulation

Standard of care DRUG

Standard of care during COVID-19 pandemic including steroids.

Not treated with immunomodulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• At least 18 years of age
• Admitted to ICU due to COVID induced moderate or severe ARDS
• Requiring mechanical ventilation

You may not qualify if:

• \- Refusing participation

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Amsterdam UMC: collaborator
• Leiden University Medical Center: collaborator
• St. Antonius Hospital: collaborator

Study Sites (1)

Erasmus Medical Centre

Rotterdam, South Holland, 3015 GD, Netherlands

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• H. Endeman, Dr.

  Erasmus Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Henrik Endeman, MD, PhD

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: March 2, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

NL (1)