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NCT06311448 | COMPLETED | COVID-19 Acute Respiratory Distress Syndrome


Personalized Targeted Immunomodulation in COVID-19 ARDS
Sponsor:

Erasmus Medical Center

Information provided by (Responsible Party):

Henrik Endeman

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.

Condition or disease

COVID-19 Acute Respiratory Distress Syndrome

Intervention/treatment

Single target immunomodulation

Standard of care

Study Type : OBSERVATIONAL
Estimated Enrollment : 164 participants
Official Title : Personalized Targeted Immunomodulation in Patients With ARDS Related to COVID19 and Future Pandemic Pathogens
Actual Study Start Date : 2020-03-02
Estimated Primary Completion Date : 2022-02-01
Estimated Study Completion Date : 2022-02-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

Personalized Targeted Immunomodulation in COVID-19 ARDS

Location Details

NCT06311448


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Netherlands, South Holland

Erasmus Medical Centre

Rotterdam, South Holland, Netherlands, 3015 GD

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