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

NCT05531149 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2025-06-08

No results posted yet for this study

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.

Conditions

  • Respiratory Infection
  • Pneumonia
  • Community-acquired Pneumonia
  • Acute Respiratory Distress Syndrome
  • COVID-19
  • Viral Pneumonia
  • Bacterial Pneumonia
  • Fungal Pneumonia

Interventions

DRUG

Trimodulin

IMP will be administered via IV infusion on 5 consecutive days

DRUG

Placebo (human albumin 1%)

IMP will be administered via IV infusion on 5 consecutive days

Sponsors & Collaborators

  • Biotest

    lead INDUSTRY

Principal Investigators

  • Antoni Torres, Prof · Hospital Clinic de Barcelona, Barcelona, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Argentina
  • Austria
  • Belgium
  • Brazil
  • France
  • Germany
  • Hungary
  • Latvia
  • Lithuania
  • Portugal
  • Slovakia
  • South Africa
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05531149 on ClinicalTrials.gov