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Completed

NCT Number: NCT04542226

Observational Open Study of Polyoxidonium in 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).

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Key information

Conditions

Infections, Coronavirus Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Healthcare Institution "Grodno Regional Infectious Clinical Hospital", Grodno, Belarus

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

  • 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.

Treatment and study plan

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)

Other names: azoximer bromide

Primary outcomes

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

    Time frame: Day 1 (Baseline), Day 15

    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).

Secondary outcomes

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

    Time frame: Days 1 - 29.

    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.

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

    Time frame: Days 1 - 29.

    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.

  3. Number of Patients Requiring Supplementary Oxygen

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

    Number of patients requiring supplementary oxygen on Days 3, 5, 8, 11, 15, 29

  4. Hospitalisation Duration

    Time frame: Days 1 - 29

    Duration of hospitalisation

  5. Mortality

    Time frame: Days 1 - 29.

    Number of participants who were dead or alive (Days 1 - 29)

  6. The Number of Participants With Serious Adverse Events

    Time frame: Days 1 - 29.

    The number of participants with serious adverse events (SAE)

  7. The Number of Participants With Adverse Events

    Time frame: Days 1 - 29.

    The number of participants with adverse events (AE)

  8. Number of Participants With Discontinuation of Drug Administration

    Time frame: Days 1 - 17.

    Number of participants with Permanent or temporary discontinuation of infusions or injections due to adverse events

Sponsors and collaborators

Lead sponsor

NPO Petrovax

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2020
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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