NCT04576728

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

A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase II Trial Investigating the Efficacy and Safety of Trimodulin (BT588) as add-on Therapy to Standard of Care in Adult Subjects With Severe COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Biotest · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, placebo-controlled, double-blind, multi-center, phase II trial investigating the efficacy and safety of trimodulin compared to placebo treatment, as add-on therapy to SoC in adult subjects with severe COVID-19. Severe COVID-19 patients with need for non-invasive ventilation or high flow oxygen and with dysregulated inflammatory responses demonstrated by an elevated CRP level, will be enrolled. Subjects will be randomized to receive either trimodulin or placebo on a 1:1 basis, stratified by center. Investigational Medicinal Product (IMP) treatments will be blinded. Subjects will be administered IMP once daily on five consecutive days (day 1 through day 5) as add-on therapy to SoC. The subsequent follow-up phase comprises 23 \[+3\] days (day 6 through day 28) followed by an end-of-trial visit/ telephone call on day 29 \[+3\]. For evaluation of this trial, a 9-category ordinal scale will be used. The primary aim of trimodulin treatment in the enrolled severely ill patients with a score of 5, is to prevent their clinical deterioration to a critical disease stage (score 6-7, e.g. requiring invasive mechanical ventilation or ECMO) and death (score 8). Accordingly, a composite primary efficacy endpoint reflecting the deterioration / mortality rate is used.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Trimodulin	IMP will be administered via IV infusion on 5 consecutive days.
OTHER	Placebo (human albumin 1%)	IMP will be administered via IV infusion on 5 consecutive days.

Timeline

• Start date: 2020-10-06
• Primary completion: 2021-06-29
• Completion: 2021-06-29
• First posted: 2020-10-06
• Last updated: 2023-01-10

Locations

17 sites across 4 countries: Brazil, France, Russia, Spain