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

NCT04542226 | Completed Results

• 1 other identifier: Covid_v_1.0
• Study Type: observational
• Target: 81
• Locations: 2 countries
• Sites: 5

Brief Summary

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).

Conditions

Infections, Coronavirus

Outcome Measures

Primary Outcomes (1)

• Clinical Status of the Patient (According to 7-point Ordinal Scale)

  Subject clinical status using the 7-point Ordinal Scale, specified as the primary endpoint in the WHO Master Protocol on day 15 as compared to baseline (1 - Not hospitalized, no limitations on activities; 2 - Not hospitalized, limitation on activities; 3 - Hospitalized, not requiring supplemental oxygen; 4 - Hospitalized, requiring supplemental oxygen; 5 - Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6 - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 7 - Death).

  Day 1 (Baseline), Day 15

Secondary Outcomes (8)

• Time to Improvement in Clinical Status of the Patient (According to Ordinal Scale) by 1 Point for Each OS Score

  Days 1 - 29.

• Clinical Status of the Patient (According to National Early Warning Score (NEWS Scale))

  Days 1 - 29.

• Number of Patients Requiring Supplementary Oxygen

  Days intervals 1 (baseline), 3, 5, 8, 11, 15, 29.

• Hospitalisation Duration

  Days 1 - 29

• Mortality

  Days 1 - 29.

Study Arms (1)

Adult patients hospitalized with COVID-19

Patients eligible for enrollment into the study

Drug: Polyoxidonium

Interventions

Polyoxidonium 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)

Also known as: azoximer bromide

Adult patients hospitalized with COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized adult patients with verified diagnosis of COVID-19 administered Polyoxidonium, according to the instruction for its medical usage in complex with Russian MoH guidance for treatment of COVID-19

You may qualify if:

• The hospitalized patient was administered Polyoxidonium, according to the instruction for medical usage in complex with Russian MoH guidance for treatment of COVID-19.
• 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.
• The patient signed an Informed Consent form for participation in this study.
• The patient can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol.
• Male and female patients from 18 years of age.

You may not qualify if:

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

Sponsors & Collaborators

• NPO Petrovax: lead

Study Sites (5)

Healthcare Institution "Grodno Regional Infectious Clinical Hospital"

Grodno, 230030, Belarus

Location

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

Cheboksary, Chuvashskaya Respublika, 428017, Russia

Location

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

Novorossiysk, Krasnodarskiy Kray, 353915, Russia

Location

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

Yoshkar-Ola, Mari El Republic, 424005, Russia

Location

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

Novaya Usman', Voronezh Oblast, 396310, Russia

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

azoximer bromide

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Limitations and Caveats

There was no control or comparison group, polyoxidonium was used in the treatment of all patients, it is not possible to compare the results of treatment of patients with and without Polyoxidonium. The study used various treatment regimens for COVID-19 (antiviral agents, antimalarial agents, anticoagulants), depending on the base of the study, so it is impossible to fully determine whether these agents influenced the effectiveness of Polyoxidonium.

Results Point of Contact

• Title: Nikolay Dodonov, Head of medical department
• Organization: NPO Petrovax Pharm, LLC

DodonovNS@petrovax.ru

Phone: +7(495) 730-75-45 ext.

Study Officials

• Nikolay S. Dodonov

  NPO Petrovax

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 9, 2020
• Study Start: March 31, 2020
• Primary Completion: July 15, 2020
• Study Completion: October 30, 2020
• Last Updated: December 9, 2020
• Results First Posted: December 3, 2020

Record last verified: 2020-12

Locations

BE (1); RU (4)