Clinical Study in the Treatment of Patients With COVID-19

COVID-19 Clinical Trial

Official title: Clinical Study to Analyze the Safety and Efficacy of Molixan® as Part of Standard Therapy in the Treatment of Patients With the Severe Course of New Coronavirus Infection (COVID-19)

Status Recruiting

Clinical Trial Summary

Multicenter, prospective, double-blind, placebo-controlled, randomized, parallel-group phase III study.

The study is designed for 2 treatment groups:

• Group 1 of the investigational drug - Patients receive standard therapy and the investigational drug.

• Group 2 of comparison - Patients receive standard therapy and placebo.

Clinical Trial Description

Patients with the severe course of COVID-19 infection confirmed by PCR laboratory test will be involved in the study on a voluntary basis.

In accordance with regulatory enactments, these patients receive specialized medical care in specialized medical institutions, where the conduct of the study is planned.

The study is planned as a double-blind, which will be achieved by using Molixan and placebo (0.9% NaCl solution) in the same packaging with the same labeling, indistinguishable in color and smell.

Patients will be randomized in an unpredictable manner using the IWRS system.

It is planned to divide patients into 2 parallel groups:

1. Group 1. Standard therapy + Molixan;

2. Group 2. Standard therapy + placebo. The regimen (1 or 2) assigned to each study subject will not be known to either the Investigator or the patient. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT04780672
• Study type: Interventional
• Source: Pharma VAM
• Contact: Mark Borisovich Balazovskij
• Phone: +7 (812) 714-10-10
• Email: vam@glutoxim.ru
• Status: Recruiting
• Phase: Phase 3
• Start date: March 9, 2021
• Completion date: September 30, 2022