drugset / Trial / NCT05531149
Efficacy and Safety of Trimodulin (BT588) in Subjects With CAP Including COVID-19 Pneumonia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trimodulin | Protein / enzyme biologic | — | Intravenous |