Efficacy and Safety of Trimodulin in Subjects With Severe COVID-19

Summary

The objectives of the trial are to evaluate the efficacy and safety of trimodulin as add-on therapy to standard of care (SoC) compared to placebo treatment in adult hospitalized subjects with severe COVID-19. Additionally, pharmacodynamic (PD) and pharmacokinetic (PK) properties of trimodulin will be evaluated in all subjects.

Timeline

Start

2020-10-06

Primary completion

2021-06-29

Completion

2021-06-29

Outcome

Missed primary endpoint

paper The primary efficacy endpoint was reported in 33.3% of patients on trimodulin and 34.1% of patients on placebo (P = 0.912). PMID 39138518 ↗

Publications

• Agafina A, Aguiar VC, Rossovskaya M, Fartoukh MS, Hajjar LA, Thiery G, Timsit JF, Gordeev I, Protsenko D, Carbone J, Pellegrini R, Stadnik CMB, Avdeev S, Ferrer M, Heinz CC, Hader T, Langohr P, Bobenhausen I, Schuttrumpf J, Staus A, Ruehle M, Weissmuller S, Wartenburg-Demand A, Torres A. Efficacy and safety of trimodulin in patients with severe COVID-19: results from a randomised, placebo-controlled, double-blind, multicentre, phase II trial (ESsCOVID). Eur J Med Res. 2024 Aug 13;29(1):418. doi: 10.1186/s40001-024-02008-x.

Drugs

Indications