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Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19

NCT04381377 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2024-08-23

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the superiority of Polyoxidonium®, lyophilizate for solution for injections and topical application, 6 mg over placebo in hospitalized patients with coronavirus disease (COVID-19). This is a multicentre prospective, randomized, double-blind, placebo-controlled, parallel-group phase IIb\\IIIa clinical trial.

Conditions

  • Infections, Coronavirus

Interventions

DRUG

azoximer bromide

Investigational medicinal product

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • NPO Petrovax

    lead INDUSTRY

Principal Investigators

  • Jean-Francois Rossi, Professor · University of Montpellier (Faculté de Médecine) and Institute Sainte Catherine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-28
Primary Completion
2021-03-03
Completion
2021-04-23

Countries

  • Russia
  • Slovakia

Study Locations

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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 NCT04381377 on ClinicalTrials.gov