MedTrace Logo

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

NCT04576728 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2023-01-10

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

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.

Sponsors & Collaborators

  • Biotest

    lead INDUSTRY

Principal Investigators

  • Antoni Torres, MD · University of Barcelona Hospital Clinic of 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
2020-10-06
Primary Completion
2021-06-29
Completion
2021-06-29

Countries

  • Brazil
  • France
  • Russia
  • Spain

Study Locations

More Related Trials

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 NCT04576728 on ClinicalTrials.gov