Personalized Targeted Immunomodulation in COVID-19 ARDS (COMODULATE)

Erasmus University

Status: Completed

Conditions: COVID-19 Acute Respiratory Distress Syndrome

Treatments: Drug: Standard of care; Drug: Single target immunomodulation

Study type: Observational

Funder types: Other

Identifiers

NCT06311448

10094

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

164 participants in 2 patient groups

Treated with immunomodulation

Description:

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.

Treatment:

Drug: Single target immunomodulation

Not treated with immunomodulation

Description:

Adult patients with COVID-19 ARDS admitted to ICU and requiring mechanical ventilation and receiving standard of care treatment (including steroids).

Treatment:

Drug: Standard of care