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

NCT ID: NCT04542226

Last Updated: 2020-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-31

Study Completion Date

2020-10-30

Brief Summary

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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

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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

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Infections, Coronavirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult patients hospitalized with COVID-19

Patients eligible for enrollment into the study

Polyoxidonium

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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azoximer bromide

Eligibility Criteria

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Inclusion Criteria

1. The hospitalized patient was administered Polyoxidonium, according to the instruction for medical usage in complex with Russian MoH guidance for treatment of COVID-19.
2. Verified coronavirus disease COVID-19, and at least one of the following:

* severe disease: mechanical ventilation or oxygen supply required with blood oxygen saturation (SpO2) ≤ 94% on room air or tachypnea, respiratory rate ≥ 24 breaths per minute,
* mild-moderate disease: SpO2 \> 94% on room air or respiratory rate \< 24 breaths per minute.
3. The patient signed an Informed Consent form for participation in this study.
4. The patient can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol.
5. Male and female patients from 18 years of age.
6. Confirmed diagnosis of coronavirus disease (COVID-19): laboratory-confirmed Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen prior to inclusion.

Exclusion Criteria

1. Pregnancy or breastfeeding.
2. Pathological condition that the study doctor considers significant enough to prevent enrolment of this patient.
3. Participation in any clinical study within 30 days before the Informed Consent form provided.
4. Hypersensitivity and/or intolerability to any ingredient of the investigational product.
5. Acute or chronic renal failure.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NPO Petrovax

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nikolay S. Dodonov

Role: STUDY_CHAIR

NPO Petrovax

Locations

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Healthcare Institution "Grodno Regional Infectious Clinical Hospital"

Grodno, , Belarus

Site Status

State-Funded Healthcare Institution "Emergency Hospital" of Ministry of Health of Chuvash Republic

Cheboksary, Chuvashskaya Respublika, Russia

Site Status

State-Funded Healthcare Institution "Infectious Disease Hospital No.3" of Ministry of Health of Krasnodar Krai

Novorossiysk, Krasnodarskiy Kray, Russia

Site Status

State-Funded Institution of Mari El Republic "Yoshkar-Ola City Hospital"

Yoshkar-Ola, Mari El Republic, Russia

Site Status

State-Funded Healthcare Institution of Voronezh Region "Novaya Usman District Hospital"

Novaya Usman', Voronezh Oblast, Russia

Site Status

Countries

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Belarus Russia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Covid_v_1.0

Identifier Type: -

Identifier Source: org_study_id