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).
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.
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)
Other Name: azoximer bromide
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.
Healthcare Institution "Grodno Regional Infectious Clinical Hospital"
Grodno, Belarus
State-Funded Healthcare Institution "Emergency Hospital" of Ministry of Health of Chuvash Republic
Cheboksary, Chuvashia, Russian Federation
State-Funded Healthcare Institution "Infectious Disease Hospital No.3" of Ministry of Health of Krasnodar Krai
Novorossiysk, Krasnodar Krai, Russian Federation
State-Funded Institution of Mari El Republic "Yoshkar-Ola City Hospital"
Yoshkar-Ola, Mari El Republic, Russian Federation
State-Funded Healthcare Institution of Voronezh Region "Novaya Usman District Hospital"
Novaya Usman, Voronezh Region, Russian Federation
Nikolay S. Dodonov, Study Chair
NPO Petrovax