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

NCT04381377 | Completed Phase 2 DMC

• 1 other identifier: PО-COV-III-20
• Study Type: interventional
• Target: 394
• Locations: 2 countries
• Sites: 14

Brief 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

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Clinical status of the patient (according to 7-point ordinal scale)

  The primary efficacy outcome will be defined based on the blinded analysis of data of the first 100 patients in the 1st part of the study. There is uncertainty about the clinical course and potential different trajectories according to baseline disease severity, so the day of the primary endpoint may be modified based on a blinded evaluation of the primary efficacy outcome in various days.

  Day 15

Secondary Outcomes (5)

• Clinical status of the patient (according to 7-point ordinal scale)

  Clinical status of the patient and the average change in the ordinal scale from baseline, both on days 3, 5, 8, 11, 29.

• NEWS

  Change in NEWS from baseline on days 3, 5, 8, 11, 15, 29.

• Oxygenation

  Oxygenation free days in the first 28 days (to day 29). Incidence and duration of new oxygen use during the study.

• Mechanical Ventilation

  Ventilator free days in the first 28 days (to day 29). Incidence and duration of new mechanical ventilation use during the trial.

• Mortality

  28-day mortality

Study Arms (2)

Polyoxidonium

EXPERIMENTAL

Polyoxidonium will be 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).

Drug: azoximer bromide

Placebo

PLACEBO COMPARATOR

Placebo will be administered (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).

Other: Placebo

Interventions

azoximer bromide DRUG

Investigational medicinal product

Also known as: Polyoxidonium

Polyoxidonium

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients from 18 to 85 years of age.
• The patient (or his/her legal representative, if the patient is not able to sign the form) signed an Informed Consent form for participation in this study before any initiation of any study procedures.
• The patient can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol.
• Confirmed diagnosis of coronavirus disease (COVID-19): laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen \< 14 days prior to randomization.
• Illness (coronavirus disease COVID-19) of any duration, and at least one of the following:
• Radiographic/tomographic chest infiltrates by imaging (chest x-ray, CT scan, etc.), OR
• Evidence of rales/crackles on clinical exam AND SpO2 ≤ 94% on room air, OR
• Indications for mechanical ventilation and/or supplemental oxygen.
• Agrees to use adequate contraception methods (the methods with at least 90% efficacy include non-hormonal intrauterine devices; condom with intravaginal spermicide; cervical caps

You may not qualify if:

• History of clinically significant allergic reactions.
• Hypersensitivity and/or intolerability to any ingredient of the investigational product or placebo.
• Anticipated transfer to another hospital which is not a study centre within the next 72 hours.
• Acute or chronic renal failure.
• History of HIV infection, tuberculosis.
• Conditions associated with primary immunodeficiency.
• Concomitant use of cytostatic medications to treat a concomitant disease.
• Systemic connective tissue diseases.
• Need for the prohibited medications.
• Administration of medications that are prohibited or unauthorized by the protocol within 2 weeks before the expected randomization date.
• History of alcohol or drug dependence.
• History of malignant tumours of any location with remission for less than 2 years.
• History of psychic (including depressive) disorders, physical and other factors that do not allow for adequate self-assessment of one's behaviour and for compliance with the protocol requirements, including history of psychiatric disorders.
• Pregnancy or breastfeeding.
• Intravenous injections and/or sampling of the required amount of blood is not possible.

Sponsors & Collaborators

• NPO Petrovax: lead

Study Sites (14)

Regional state budgetary institution of public health "City hospital No. 5 of Barnaul"

Barnaul, 656045, Russia

Location

Central Research Institute of Epidemiology of Rospotrebnadzor

Moscow, 111123, Russia

Location

The state healthcare institution of the city of Moscow "City Clinical Hospital No. 15 named after OM Filatov" in "Moscow City Department of Health"

Moscow, 111539, Russia

Location

Moscow State Budgetary Healthcare Institution "Infectious Clinical Hospital No. 1 of the Moscow Department of Healthcare"

Moscow, 125367, Russia

Location

Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 24 of the Moscow Department of Healthcare"

Moscow, 127015, Russia

Location

State budgetary institution "Research Institute of Emergency Care named after N.V. Sklifosovsky in Department of Health of the city of Moscow"

Moscow, 129090, Russia

Location

Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 40 of the Moscow Department of Healthcare"

Moscow, 129301, Russia

Location

State budgetary institution of health care of the Nizhny Novgorod region "Infectious clinical hospital No. 2 of Nizhny Novgorod"

Nizhny Novgorod, 603022, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Health of the Russian Federation

Orenburg, 460000, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after Academician I.P. Pavlov

Saint Petersburg, 197022, Russia

Location

State budgetary health institution of the Vladimir region "Regional Clinical Hospital"

Vladimir, 600023, Russia

Location

Yaroslavl State Medical University of Ministry of Health of the Russian Federation

Yaroslavl, 150000, Russia

Location

Clinics of Infectious Diseases, University Hospital in Nitra

Nitra, 949 01, Slovakia

Location

Clinics of Infectious Diseases, University Hospital in Trnava

Trnava, 917 74, Slovakia

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

azoximer bromide

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jean-Francois Rossi, Professor

  University of Montpellier (Faculté de Médecine) and Institute Sainte Catherine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 8, 2020
• Study Start: April 28, 2020
• Primary Completion: March 3, 2021
• Study Completion: April 23, 2021
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

RU (12); SL (2)