An observational study in Infections, Coronavirus, sponsored by NPO Petrovax. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-09.
Sponsored by NPO Petrovax · Observational
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.
929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.
This study's enrollment of 81 is below the median of 300 across 334 observational studies indexed under Coronavirus Infections.
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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
Verified coronavirus disease COVID-19, and at least one of the following:
Exclusion Criteria:
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)
Also known as: azoximer bromide
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).
Time frame: Day 1 (Baseline), Day 15
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: 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.
Time frame: 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.
Time frame: Days 1 - 29.
Number of Patients Requiring Supplementary Oxygen
Number of patients requiring supplementary oxygen on Days 3, 5, 8, 11, 15, 29
Time frame: Days intervals 1 (baseline), 3, 5, 8, 11, 15, 29.
Hospitalisation Duration
Duration of hospitalisation
Time frame: Days 1 - 29
Mortality
Number of participants who were dead or alive (Days 1 - 29)
Time frame: Days 1 - 29.
The Number of Participants With Serious Adverse Events
The number of participants with serious adverse events (SAE)
Time frame: Days 1 - 29.
The Number of Participants With Adverse Events
The number of participants with adverse events (AE)
Time frame: 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
Time frame: Days 1 - 17.
| Milestone | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Started | 81 |
| Completed | 81 |
| Not completed | 0 |
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).
| Participants | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Number of patients at Baseline (Day 1) — 1. Not hospitalized, no limitations on activities | 0 |
| Number of patients at Baseline (Day 1) — 2. Not hospitalized, limitation on activities | 0 |
| Number of patients at Baseline (Day 1) — 3. Hospitalized, not requiring supplemental oxygen | 22 |
| Number of patients at Baseline (Day 1) — 4. Hospitalized, requiring supplemental oxygen | 24 |
| Number of patients at Baseline (Day 1) — 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices | 24 |
| Number of patients at Baseline (Day 1) — 6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation | 11 |
| Number of patients at Baseline (Day 1) — 7. Death | 0 |
| Number of patients on Day 15 — 1. Not hospitalized, no limitations on activities | 3 |
| Number of patients on Day 15 — 2. Not hospitalized, limitation on activities | 27 |
| Number of patients on Day 15 — 3. Hospitalized, not requiring supplemental oxygen | 37 |
| Number of patients on Day 15 — 4. Hospitalized, requiring supplemental oxygen | 9 |
| Number of patients on Day 15 — 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices | 3 |
| Number of patients on Day 15 — 6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation | 2 |
| Number of patients on Day 15 — 7. Death | 0 |
Ordinal scale (OS) score status, time to improvement by 1 point for each OS score. Subject clinical status using the 7-point Ordinal Scale: 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.
| days | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Time to Improvement in Clinical Status of the Patient (According to Ordinal Scale) by 1 Point for Each OS Score | 13.77 ± 6.01 |
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 | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Clinical Status of the Patient (According to National Early Warning Score (NEWS Scale)) | 8.85 ± 6.10 |
Number of patients requiring supplementary oxygen on Days 3, 5, 8, 11, 15, 29
| Participants | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Baseline (Day 1) — Number of patients requiring supplementary oxygen | 59 |
| Baseline (Day 1) — Number of patients not requiring respiratory support | 22 |
| Day 3 — Number of patients requiring supplementary oxygen | 58 |
| Day 3 — Number of patients not requiring respiratory support | 23 |
| Day 5 — Number of patients requiring supplementary oxygen | 56 |
| Day 5 — Number of patients not requiring respiratory support | 25 |
| Day 8 — Number of patients requiring supplementary oxygen | 47 |
| Day 8 — Number of patients not requiring respiratory support | 34 |
| Day 11 — Number of patients requiring supplementary oxygen | 31 |
| Day 11 — Number of patients not requiring respiratory support | 50 |
| Day 15 — Number of patients requiring supplementary oxygen | 14 |
| Day 15 — Number of patients not requiring respiratory support | 67 |
| Day 29 — Number of patients requiring supplementary oxygen | 1 |
| Day 29 — Number of patients not requiring respiratory support | 80 |
Duration of hospitalisation
| days | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Hospitalisation Duration | 19.13 ± 5.29 |
Number of participants who were dead or alive (Days 1 - 29)
| Participants | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Alive | 81 |
| Dead | 0 |
The number of participants with serious adverse events (SAE)
| Participants | Adult Patients Hospitalized With COVID-19 |
|---|---|
| The Number of Participants With Serious Adverse Events | 1 |
The number of participants with adverse events (AE)
| Participants | Adult Patients Hospitalized With COVID-19 |
|---|---|
| The Number of Participants With Adverse Events | 7 |
Number of participants with Permanent or temporary discontinuation of infusions or injections due to adverse events
| Participants | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Administration of Polyoxidonium was canceled due to Adverse event | 1 |
| Administration of Polyoxidonium was postponed by 1 day due to Adverse event | 2 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adult Patients Hospitalized With COVID-19 | 0/81 (0%) | 1/81 (1.2%) | 6/81 (7.4%) |
| Event | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Klebsiella sepsisInfections and infestations | 1/81 |
| Event | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Fever (Intermittent fever included) / PyrexiaGeneral disorders | 3/81 |
| PQ interval prolonged / Electrocardiogram PR prolongation*Investigations | 2/81 |
| Pneumonia bacterialInfections and infestations | 1/81 |
| Age, Categorical(Participants) | Adult Patients Hospitalized With COVID-19 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 71 |
| >=65 years | 10 |
| Age, Continuous(years) | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Mean | 50.88 ± 12.81 |
| Sex: Female, Male(Participants) | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Female | 44 |
| Male | 37 |
| Race (NIH/OMB)(Participants) | Adult Patients Hospitalized With COVID-19 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 77 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Belarus | 10 |
| Russia | 71 |
| Baseline severity according to the National Early Warning Score (NEWS Score)(Participants) | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Very Severe (NEWS ≥ 9) | 30 |
| Severe or Moderate (NEWS = 5…8) | 28 |
| Mild (NEWS ≤ 4) | 23 |
| Respiratory support type(Participants) | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Invasive lung ventilation | 14 |
| Non-invasive lung ventilation | 25 |
| Oxygen therapy | 25 |
| None | 17 |
| Mechanical ventilation(Participants) | Adult Patients Hospitalized With COVID-19 |
|---|---|
| Present | 39 |
| Absent | 42 |
3 further baseline measures are reported on the registry.
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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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