Clinical Study in the Treatment of Patients With COVID-19

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.

Conditions

• COVID-19

Interventions

DRUG

Molixan

The investigational drug in this study is Molixan in the dosage form of 30 mg/ml solution for intravenous and intramuscular injection. Against the background of standard therapy: Molixan® at a dose of 3.0 mg/kg per day is administered once intravenously (stream injection) with 0.9% sodium chloride solution at a volume ratio of 1:1 for 10 days.

DRUG

Placebo

Placebo will be used as a comparator drug and will be an analogue of the investigational drug without active substance. Against the background of standard therapy: Placebo at a dose of 3.0 mg/kg per day is administered once intravenously (stream injection) with 0.9% sodium chloride solution at a volume ratio of 1:1 for 10 days.

Sponsors & Collaborators

• Pharma VAM

  lead OTHER

Principal Investigators

• Viktor Borisovich Filimonov · Federal State Budgetary Educational Institution of Higher Education

• Tamara Valerievna Gaigolnik · Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency, Krasnoyarsk

• Halida Hanafievna Ganceva · Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Healthcare of the Russian Federation

• Elena Petrovna Dmitrikova · State Budgetary Institution of Healthcare of Moscow Region "Zhukovskaya City Clinical Hospital", Zhukovskiy, Moscow Region, Russian Federation

• Mariya Evgen'evna Mozhejko · Yaroslavl Regional Clinical Hospital for War Veterans - The International Center for the Elderly "Healthy Longevity"

• Halit Saubanovich Haertynv · Republican Clinical Infectious Diseases Hospital named after professor Agafonov

• Zoya Gennad'evna Tatarinceva · State Budgetary Healthcare Institution "Research Institute - Regional Clinical Hospital No. 1 named after Professor S. V. Ochapovsky" of the Ministry of Health of the Krasnodar Territory

• Aleksandr Alekseevich Punin · Regional State Budgetary Healthcare Institution "Smolensk Regional Clinical Hospital"

• Dmitrij YUr'evich Konstantinov · Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Healthcare of the Russian Federation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-09

Primary Completion

2022-05-31

Completion

2022-09-30

Countries

• Russia

Study Locations