Personalized Targeted Immunomodulation in COVID-19 ARDS

Completed

• Conditions: COVID-19 Acute Respiratory Distress Syndrome
• Interventions: Drug: Single target immunomodulation; Drug: Standard of care

• Registration Number: NCT06311448
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-02
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-13
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

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

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Exclusion Criteria

• Refusing participation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated with immunomodulation	Single target 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.
Not treated with immunomodulation	Standard of care	Adult patients with COVID-19 ARDS admitted to ICU and requiring mechanical ventilation and receiving standard of care treatment (including steroids).

Primary Outcome Measures

Name	Time	Method
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	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	During the full course of ICU admission. The length of ICU-stays varies per patient.	Number of ventilator free days
Change in biomarker values	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	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.

Trial Locations

Locations (1)

Erasmus Medical Centre; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands