NCT04542226

Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19

Open Observational Study of Efficacy and Safety of Polyoxidonium in Complex Therapy of Hospitalized Patients With COVID-19

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: NPO Petrovax · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The study is designed as an open observational non-comparative study of Polyoxidonium®, lyophilizate for solution for injections and topical application, 12 mg in hospitalized patients with coronavirus disease (COVID-19).

Detailed description

The study was planned as an observation of Polyoxidonium® administered in addition to Russian Ministry of Healthcare (MoH) guidance for standard COVID-19 treatment. Regimens have no limitations to the use of concomitant therapy. The aim of the study is to observe the safety and efficacy of Polyoxidonium®, lyophilizate for solution for injections, 12 mg in addition to complex treatment of hospitalized patients with COVID-19.

Conditions

• Infections, Coronavirus

Interventions

Type	Name	Description
DRUG	Polyoxidonium	Polyoxidonium (azoximer bromide) is administered in the dose of 12 mg (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections)

Timeline

• Start date: 2020-03-31
• Primary completion: 2020-07-15
• Completion: 2020-10-30
• First posted: 2020-09-09
• Last updated: 2020-12-09
• Results posted: 2020-12-03

Locations

5 sites across 2 countries: Belarus, Russia