drugset / Trial / NCT05722938

Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)

NCT05722938 ↗

Phase 3 Recruiting 590 enrolled Biotest
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.

Timeline

Start
2023-09-09
Primary completion
2028-07-31
Completion
2028-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Trimodulin Protein / enzyme biologic — Intravenous

Indications