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

Open Observational Study of Efficacy and Safety of Polyoxidonium in Complex Therapy of Hospitalized Patients With COVID-19

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).

Study Overview

• Status: Completed
• Conditions: Infections, Coronavirus
• Intervention / Treatment: Drug: Polyoxidonium

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• Belarus
  • Grodno, Belarus, 230030
    • Healthcare Institution "Grodno Regional Infectious Clinical Hospital"
• Russian Federation
  • Chuvashia
    • Cheboksary, Chuvashia, Russian Federation, 428017
      • State-Funded Healthcare Institution "Emergency Hospital" of Ministry of Health of Chuvash Republic
  • Krasnodar Krai
    • Novorossiysk, Krasnodar Krai, Russian Federation, 353915
      • State-Funded Healthcare Institution "Infectious Disease Hospital No.3" of Ministry of Health of Krasnodar Krai
  • Mari El Republic
    • Yoshkar-Ola, Mari El Republic, Russian Federation, 424005
      • State-Funded Institution of Mari El Republic "Yoshkar-Ola City Hospital"
  • Voronezh Region
    • Novaya Usman, Voronezh Region, Russian Federation, 396310
      • State-Funded Healthcare Institution of Voronezh Region "Novaya Usman District Hospital"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients hospitalized with COVID-19; Patients eligible for enrollment into the study	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 Names: azoximer bromide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Improvement in Clinical Status of the Patient (According to Ordinal Scale) by 1 Point for Each OS Score	Ordinal scale (OS) score status, time to improvement by 1 point for each OS score. Subject clinical status using the 7-point Ordinal Scale: - Not hospitalized, no limitations on activities;; - Not hospitalized, limitation on activities;; - Hospitalized, not requiring supplemental oxygen;; - Hospitalized, requiring supplemental oxygen;; - Hospitalized, on non-invasive ventilation or high flow oxygen devices;; - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation;; - Death.	Days 1 - 29.
Clinical Status of the Patient (According to National Early Warning Score (NEWS Scale))	NEWS scale score status, time to a discharge from a hospital or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. NEWS score is based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, temperature. A score of 0, 1, 2, 3 is allocated to each parameter except supplemental oxygen (a score 0 or 1 is allocated) and level of consciousness (a score 0 or 3 is allocated). A higher score means the parameter is further from the normal range. All scores were summed to get an aggregate score. Aggregate score ranges from 0 to 19, with higher scores meaning higher risk. Low risk - aggregate score, 1-4 Low to medium risk - score 3 in any single parameter, Medium risk - aggregate score 5-6, High risk - aggregate score 7-19.	Days 1 - 29.
Number of Patients Requiring Supplementary Oxygen	Number of patients requiring supplementary oxygen on Days 3, 5, 8, 11, 15, 29	Days intervals 1 (baseline), 3, 5, 8, 11, 15, 29.
Hospitalisation Duration	Duration of hospitalisation	Days 1 - 29
Mortality	Number of participants who were dead or alive (Days 1 - 29)	Days 1 - 29.
The Number of Participants With Serious Adverse Events	The number of participants with serious adverse events (SAE)	Days 1 - 29.
The Number of Participants With Adverse Events	The number of participants with adverse events (AE)	Days 1 - 29.
Number of Participants With Discontinuation of Drug Administration	Number of participants with Permanent or temporary discontinuation of infusions or injections due to adverse events	Days 1 - 17.

Collaborators and Investigators

• Sponsor: NPO Petrovax
• Investigators: Study Chair: Nikolay S. Dodonov, NPO Petrovax

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2020
• Primary Completion (Actual): July 15, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections; Anticonvulsants; Bromides
• Other Study ID Numbers: Covid_v_1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No