Trial Outcomes & Findings for Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19 (NCT NCT04542226)
NCT ID: NCT04542226
Last Updated: 2020-12-09
Results Overview
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).
COMPLETED
81 participants
Day 1 (Baseline), Day 15
2020-12-09
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
COMPLETED
|
81
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19
Baseline characteristics by cohort
| Measure |
Adult Patients Hospitalized With COVID-19
n=81 Participants
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)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
71 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
50.88 years
STANDARD_DEVIATION 12.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Belarus
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
71 participants
n=5 Participants
|
|
Baseline severity according to the National Early Warning Score (NEWS Score)
Very Severe (NEWS ≥ 9)
|
30 Participants
n=5 Participants
|
|
Baseline severity according to the National Early Warning Score (NEWS Score)
Severe or Moderate (NEWS = 5…8)
|
28 Participants
n=5 Participants
|
|
Baseline severity according to the National Early Warning Score (NEWS Score)
Mild (NEWS ≤ 4)
|
23 Participants
n=5 Participants
|
|
Respiratory support type
Invasive lung ventilation
|
14 Participants
n=5 Participants
|
|
Respiratory support type
Non-invasive lung ventilation
|
25 Participants
n=5 Participants
|
|
Respiratory support type
Oxygen therapy
|
25 Participants
n=5 Participants
|
|
Respiratory support type
None
|
17 Participants
n=5 Participants
|
|
Mechanical ventilation
Present
|
39 Participants
n=5 Participants
|
|
Mechanical ventilation
Absent
|
42 Participants
n=5 Participants
|
|
Basic concomitant medication
Antivirals
|
46 Participants
n=5 Participants
|
|
Basic concomitant medication
Antimalarial
|
37 Participants
n=5 Participants
|
|
Basic concomitant medication
Anticoagulants
|
41 Participants
n=5 Participants
|
|
Ordinal Scale (OS) score
|
4.30 units on a scale
STANDARD_DEVIATION 1.02 • n=5 Participants
|
|
News Score (National Early Warning Score)
|
6.51 units on a scale
STANDARD_DEVIATION 3.41 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline), Day 15Subject 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).
Outcome measures
| Measure |
Adult Patients Hospitalized With COVID-19
n=81 Participants
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)
|
|---|---|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients at Baseline (Day 1) · 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
24 Participants
|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients at Baseline (Day 1) · 6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation
|
11 Participants
|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients at Baseline (Day 1) · 7. Death
|
0 Participants
|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients on Day 15 · 1. Not hospitalized, no limitations on activities
|
3 Participants
|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients on Day 15 · 3. Hospitalized, not requiring supplemental oxygen
|
37 Participants
|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients on Day 15 · 7. Death
|
0 Participants
|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients at Baseline (Day 1) · 1. Not hospitalized, no limitations on activities
|
0 Participants
|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients at Baseline (Day 1) · 2. Not hospitalized, limitation on activities
|
0 Participants
|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients at Baseline (Day 1) · 3. Hospitalized, not requiring supplemental oxygen
|
22 Participants
|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients at Baseline (Day 1) · 4. Hospitalized, requiring supplemental oxygen
|
24 Participants
|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients on Day 15 · 2. Not hospitalized, limitation on activities
|
27 Participants
|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients on Day 15 · 4. Hospitalized, requiring supplemental oxygen
|
9 Participants
|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients on Day 15 · 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices
|
3 Participants
|
|
Clinical Status of the Patient (According to 7-point Ordinal Scale)
Number of patients on Day 15 · 6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 1 - 29.Population: 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.
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.
Outcome measures
| Measure |
Adult Patients Hospitalized With COVID-19
n=80 Participants
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)
|
|---|---|
|
Time to Improvement in Clinical Status of the Patient (According to Ordinal Scale) by 1 Point for Each OS Score
|
13.77 days
Standard Deviation 6.01
|
SECONDARY outcome
Timeframe: Days 1 - 29.Population: 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.
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.
Outcome measures
| Measure |
Adult Patients Hospitalized With COVID-19
n=80 Participants
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)
|
|---|---|
|
Clinical Status of the Patient (According to National Early Warning Score (NEWS Scale))
|
8.85 days
Standard Deviation 6.10
|
SECONDARY outcome
Timeframe: Days intervals 1 (baseline), 3, 5, 8, 11, 15, 29.Number of patients requiring supplementary oxygen on Days 3, 5, 8, 11, 15, 29
Outcome measures
| Measure |
Adult Patients Hospitalized With COVID-19
n=81 Participants
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)
|
|---|---|
|
Number of Patients Requiring Supplementary Oxygen
Baseline (Day 1) · Number of patients requiring supplementary oxygen
|
59 Participants
|
|
Number of Patients Requiring Supplementary Oxygen
Baseline (Day 1) · Number of patients not requiring respiratory support
|
22 Participants
|
|
Number of Patients Requiring Supplementary Oxygen
Day 3 · Number of patients requiring supplementary oxygen
|
58 Participants
|
|
Number of Patients Requiring Supplementary Oxygen
Day 3 · Number of patients not requiring respiratory support
|
23 Participants
|
|
Number of Patients Requiring Supplementary Oxygen
Day 5 · Number of patients requiring supplementary oxygen
|
56 Participants
|
|
Number of Patients Requiring Supplementary Oxygen
Day 5 · Number of patients not requiring respiratory support
|
25 Participants
|
|
Number of Patients Requiring Supplementary Oxygen
Day 8 · Number of patients requiring supplementary oxygen
|
47 Participants
|
|
Number of Patients Requiring Supplementary Oxygen
Day 8 · Number of patients not requiring respiratory support
|
34 Participants
|
|
Number of Patients Requiring Supplementary Oxygen
Day 11 · Number of patients requiring supplementary oxygen
|
31 Participants
|
|
Number of Patients Requiring Supplementary Oxygen
Day 11 · Number of patients not requiring respiratory support
|
50 Participants
|
|
Number of Patients Requiring Supplementary Oxygen
Day 15 · Number of patients requiring supplementary oxygen
|
14 Participants
|
|
Number of Patients Requiring Supplementary Oxygen
Day 15 · Number of patients not requiring respiratory support
|
67 Participants
|
|
Number of Patients Requiring Supplementary Oxygen
Day 29 · Number of patients requiring supplementary oxygen
|
1 Participants
|
|
Number of Patients Requiring Supplementary Oxygen
Day 29 · Number of patients not requiring respiratory support
|
80 Participants
|
SECONDARY outcome
Timeframe: Days 1 - 29Population: 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.
Duration of hospitalisation
Outcome measures
| Measure |
Adult Patients Hospitalized With COVID-19
n=80 Participants
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)
|
|---|---|
|
Hospitalisation Duration
|
19.13 days
Standard Deviation 5.29
|
SECONDARY outcome
Timeframe: Days 1 - 29.Number of participants who were dead or alive (Days 1 - 29)
Outcome measures
| Measure |
Adult Patients Hospitalized With COVID-19
n=81 Participants
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)
|
|---|---|
|
Mortality
Dead
|
0 Participants
|
|
Mortality
Alive
|
81 Participants
|
SECONDARY outcome
Timeframe: Days 1 - 29.The number of participants with serious adverse events (SAE)
Outcome measures
| Measure |
Adult Patients Hospitalized With COVID-19
n=81 Participants
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)
|
|---|---|
|
The Number of Participants With Serious Adverse Events
|
1 Participants
|
SECONDARY outcome
Timeframe: Days 1 - 29.The number of participants with adverse events (AE)
Outcome measures
| Measure |
Adult Patients Hospitalized With COVID-19
n=81 Participants
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)
|
|---|---|
|
The Number of Participants With Adverse Events
|
7 Participants
|
SECONDARY outcome
Timeframe: Days 1 - 17.Number of participants with Permanent or temporary discontinuation of infusions or injections due to adverse events
Outcome measures
| Measure |
Adult Patients Hospitalized With COVID-19
n=81 Participants
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)
|
|---|---|
|
Number of Participants With Discontinuation of Drug Administration
Administration of Polyoxidonium was canceled due to Adverse event
|
1 Participants
|
|
Number of Participants With Discontinuation of Drug Administration
Administration of Polyoxidonium was postponed by 1 day due to Adverse event
|
2 Participants
|
Adverse Events
Adult Patients Hospitalized With COVID-19
Serious adverse events
| Measure |
Adult Patients Hospitalized With COVID-19
n=81 participants at risk
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)
|
|---|---|
|
Infections and infestations
Klebsiella sepsis
|
1.2%
1/81 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Adult Patients Hospitalized With COVID-19
n=81 participants at risk
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)
|
|---|---|
|
Investigations
PQ interval prolonged / Electrocardiogram PR prolongation*
|
2.5%
2/81 • Number of events 2 • 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.
|
|
General disorders
Fever (Intermittent fever included) / Pyrexia
|
3.7%
3/81 • Number of events 3 • 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.
|
|
Infections and infestations
Pneumonia bacterial
|
1.2%
1/81 • Number of events 1 • 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.
|
Additional Information
Nikolay Dodonov, Head of medical department
NPO Petrovax Pharm, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place