NCT04381377

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

A Multi-centre, Adaptive, Randomized, Double-blind, Placebo-controlled Comparative Clinical Study of the Safety and Efficacy of Polyoxidonium®, Lyophilizate for Solution for Injections and Topical Application, 6 mg (NPO Petrovax Pharm LLC, Russia) in Patients With Coronavirus Disease (COVID-19).

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 394 (actual)
• Sponsor: NPO Petrovax · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group phase 3 IIb\\IIIa trial to evaluate the efficacy of Polyoxidonium®, lyophilizate for solution for injections and topical application, 6 mg over placebo in hospitalized patients with coronavirus disease (COVID-19). A study will last for 29±3 days (maximum) for each participant and will include: screening (days -1...1); treatment period (17 days in total, days 1...17) with the administration of the investigational product Polyoxidonium/placebo (intravenous injections for 3 days, then intramuscular injections for 14 days), assessment of the clinical status, recording of AEs; follow-up period (days 18...29±3). Haematology and blood chemistry tests will be performed at day -1 and days 1,3, 8 ±1, 17±1. Assessment of the clinical status according to the 7-point ordinal scale and according to the National Early Warning Score (NEWS) scale will be done every day during hospitalization from day 1 up to and including day 17 and at the follow-up on day 29±3. The safety and tolerability will be evaluated throughout the study (from signing the Informed Consent Form to the study completion visit).

Conditions

• Infections, Coronavirus

Interventions

Type	Name	Description
DRUG	azoximer bromide	Investigational medicinal product
OTHER	Placebo	Placebo

Timeline

• Start date: 2020-04-28
• Primary completion: 2021-03-03
• Completion: 2021-04-23
• First posted: 2020-05-08
• Last updated: 2024-08-23

Locations

14 sites across 2 countries: Russia, Slovakia