Personalized Targeted Immunomodulation in COVID-19 ARDS

NCT ID: NCT06311448

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 164 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2022-02-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Single target immunomodulation

Intervention Type: 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.

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).

Standard of care

Intervention Type: DRUG

Standard of care during COVID-19 pandemic including steroids.

Interventions

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.

Intervention Type: DRUG

Standard of care

Standard of care during COVID-19 pandemic including steroids.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

St. Antonius Hospital

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Henrik Endeman

Henrik Endeman, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

H. Endeman, Dr.

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Centre

Locations

Erasmus Medical Centre

Rotterdam, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

10094

Identifier Type: -

Identifier Source: org_study_id