drugset / Trial / NCT05531149

Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia

NCT05531149 ↗

Phase 3 Terminated 107 enrolled Biotest
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main objectives of the trial are 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 non-severe community-acquired pneumonia (CAP) or moderate / severe Coronavirus Disease 2019 (COVID-19) pneumonia. Other objectives are to determine pharmacokinetic (PK) and pharmacodynamic (PD) properties of trimodulin.

Timeline

Start
2022-12-22
Primary completion
2025-05-05
Completion
2025-05-05

Outcome

Outcome not reported

Stopped (Enrollment): “Unacceptable delay of trial completion Low recruitment rate”

Drugs

EvaluationDrugModalityDoseRoute
Subject Trimodulin Protein / enzyme biologic — Intravenous