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Personalized Immunotherapy in Sepsis

NCT04990232 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2025-03-19

No results posted yet for this study

Summary

Αim of ImmunoSep is to assess whether personalized adjunctive immunotherapy directed against a state of either fulminant hyper-inflammation or immunoparalysis is able to change sepsis outcomes. Patients will be selected by a panel of biomarkers and laboratory findings and will be allocated to placebo or immunotherapy treatment according to their needs.

Conditions

Interventions

DRUG

Anakinra or rhIFNγ

In hyper-inflammation anakinra three times daily (every eight hours) for 15 days and sc 0.5 ml N/S 0.9% every other day for 15 days. In immunoparalysis IV 20 ml N/S 0.9% (10ml for patients with creatinine clearance lower than 30ml/min) three times daily (every eight hours) for 15 days and sc rhIFNγ every other day for 15 days.

DRUG

Placebo

20ml (10ml for patients with creatinine clearance lower than 30ml/min) intravenous (IV) 0.9% saline (N/S) three times daily (every eight hours) for 15 days and 0.5 ml subcutaneous (sc) 1ml 0.9% N/S every other day for a total of 15 days

Sponsors & Collaborators

  • Hellenic Institute for the Study of Sepsis

    lead OTHER

Principal Investigators

  • Evagelos Giamarellos-Bourboulis, MD, PhD · Hellenic Institute for the Study of Sepsis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-29
Primary Completion
2024-02-06
Completion
2024-04-27

Countries

  • Germany
  • Greece
  • Italy
  • Netherlands
  • Romania
  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04990232 on ClinicalTrials.gov