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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients hospitalized with COVID-19 | Patients eligible for enrollment into the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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:
|
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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:
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:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Nikolay S. Dodonov | NPO Petrovax | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Institution "Grodno Regional Infectious Clinical Hospital" | Grodno | 230030 | Belarus | |||
| State-Funded Healthcare Institution "Emergency Hospital" of Ministry of Health of Chuvash Republic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Patients Hospitalized With COVID-19 | Patients eligible for enrollment into the study 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Patients Hospitalized With COVID-19 | Patients eligible for enrollment into the study 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | Day 1 (Baseline), Day 15 |
|
Safety parameters were evaluated throughout the study in the Safety population (SAP; patients who received at least one Polyoxidonium dose, according to the prescribed treatment) from signing the informed consent to the study completion visit on Day 29±3.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adult Patients Hospitalized With COVID-19 | Patients eligible for enrollment into the study 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Klebsiella sepsis | Infections and infestations | Non-systematic Assessment | This SAE was classified by the Investigator as not related to Polyoxidonium treatment. The patient had a history of previous bacterial pneumonias over the past 3 years. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PQ interval prolonged / Electrocardiogram PR prolongation* | Investigations | Non-systematic Assessment | Patients received a combination of lopinavir+ritonavir, and this AEs was supposed by the Investigator to be caused by the antiviral drugs. After completion of antiviral treatment all symptoms eliminated and didn't require any additional actions. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nikolay Dodonov, Head of medical department | NPO Petrovax Pharm, LLC | Phone: +7(495) 730-75-45 ext. | 125 | DodonovNS@petrovax.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2020 | Nov 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C540909 | azoximer bromide |
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|
| 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. |
| Cheboksary |
| Chuvashskaya Respublika |
| 428017 |
| Russia |
| State-Funded Healthcare Institution "Infectious Disease Hospital No.3" of Ministry of Health of Krasnodar Krai | Novorossiysk | Krasnodarskiy Kray | 353915 | Russia |
| State-Funded Institution of Mari El Republic "Yoshkar-Ola City Hospital" | Yoshkar-Ola | Mari El Republic | 424005 | Russia |
| State-Funded Healthcare Institution of Voronezh Region "Novaya Usman District Hospital" | Novaya Usman' | Voronezh Oblast | 396310 | Russia |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline severity according to the National Early Warning Score (NEWS Score) | Count of Participants | Participants |
|
| Respiratory support type | Count of Participants | Participants |
|
| Mechanical ventilation | Count of Participants | Participants |
|
| Basic concomitant medication | Count of Participants | Participants |
|
| Ordinal Scale (OS) score | Clinical status assessment with 7-point ordinal scale (WHO Master Protocol [1])
| Mean | Standard Deviation | units on a scale |
|
| News Score (National Early Warning Score) | 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. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | 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:
| Administration of Polyoxidonium was canceled due to Adverse event in 1 patient. Patient received only 2 injections.This is the reason why the needed information for this Outcome Measure is absent for 1 patient. | Posted | Mean | Standard Deviation | days | Days 1 - 29. |
|
|
|
| Secondary | 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. | Administration of Polyoxidonium was canceled due to Adverse event in 1 patient. Patient received only 2 injections.This is the reason why the needed information for this Outcome Measure is absent for 1 patient. | Posted | Mean | Standard Deviation | days | Days 1 - 29. |
|
|
|
| Secondary | Number of Patients Requiring Supplementary Oxygen | Number of patients requiring supplementary oxygen on Days 3, 5, 8, 11, 15, 29 | Posted | Count of Participants | Participants | Days intervals 1 (baseline), 3, 5, 8, 11, 15, 29. |
|
|
|
| Secondary | Hospitalisation Duration | Duration of hospitalisation | Administration of Polyoxidonium was canceled due to Adverse event in 1 patient. Patient received only 2 injections.This is the reason why the needed information for this Outcome Measure is absent for 1 patient. | Posted | Mean | Standard Deviation | days | Days 1 - 29 |
|
|
|
| Secondary | Mortality | Number of participants who were dead or alive (Days 1 - 29) | Posted | Count of Participants | Participants | Days 1 - 29. |
|
|
|
| Secondary | The Number of Participants With Serious Adverse Events | The number of participants with serious adverse events (SAE) | Posted | Count of Participants | Participants | Days 1 - 29. |
|
|
|
| Secondary | The Number of Participants With Adverse Events | The number of participants with adverse events (AE) | Posted | Count of Participants | Participants | Days 1 - 29. |
|
|
|
| Secondary | Number of Participants With Discontinuation of Drug Administration | Number of participants with Permanent or temporary discontinuation of infusions or injections due to adverse events | Posted | Count of Participants | Participants | Days 1 - 17. |
|
|
|
| 0 |
| 81 |
| 1 |
| 81 |
| 6 |
| 81 |
|
|
| Fever (Intermittent fever included) / Pyrexia | General disorders | Non-systematic Assessment | Fever was apparently a result of SARS-CoV-2 infection and intoxication.It was classified by Investigators as not associated with Polyoxidonium treatment; some of them noted more rapid fever and intoxication decline in Polyoxidonium treated patients. |
|
| Pneumonia bacterial | Infections and infestations | Non-systematic Assessment | Bacterial pneumonia was diagnosed. The Investigator did not associate the development of pneumonia with PO administration. Bacterial pneumonia is common COVID-19 complication in elderly patients.The investigator consider this event as AE. |
|
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| D007239 |
| Infections |
| 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 |
|
| Number of patients not requiring respiratory support |
|
| Day 5 |
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| Day 8 |
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| Day 11 |
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| Day 15 |
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| Day 29 |
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