Trial · NCT04542226
Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19
NCT04542226, Completed, NPO Petrovax; results first posted 2020-12-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19. Trials, record NCT04542226. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04542226
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19
- NCT number
- NCT04542226
- Status
- Completed
- Enrollment
- 81 participants, actual
- Lead sponsor
- NPO Petrovax
- Conditions
- Infections, Coronavirus
- Interventions
- Polyoxidonium
- First posted
- 2020-09-09
- Last updated
- 2020-12-09
- Results first posted
- 2020-12-03
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Status of the Patient (According to 7-point Ordinal Scale) | 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 | Time to Improvement in Clinical Status of the Patient (According to Ordinal Scale) by 1 Point for Each OS Score | 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: 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 | Clinical Status of the Patient (According to National Early Warning Score (NEWS Scale)) | 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. |
| Secondary | Number of Patients Requiring Supplementary Oxygen | Days intervals 1 (baseline), 3, 5, 8, 11, 15, 29. | Number of patients requiring supplementary oxygen on Days 3, 5, 8, 11, 15, 29 |
| Secondary | Hospitalisation Duration | Days 1 - 29 | Duration of hospitalisation |
| Secondary | Mortality | Days 1 - 29. | Number of participants who were dead or alive (Days 1 - 29) |
| Secondary | The Number of Participants With Serious Adverse Events | Days 1 - 29. | The number of participants with serious adverse events (SAE) |
| Secondary | The Number of Participants With Adverse Events | Days 1 - 29. | The number of participants with adverse events (AE) |
| Secondary | Number of Participants With Discontinuation of Drug Administration | Days 1 - 17. | Number of participants with Permanent or temporary discontinuation of infusions or injections due to adverse events |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Status of the Patient (According to 7-point Ordinal Scale) | Day 1 (Baseline), Day 15 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Improvement in Clinical Status of the Patient (According to Ordinal Scale) by 1 Point for Each OS Score | Days 1 - 29. | 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. | days | MEAN |
| SECONDARY | Clinical Status of the Patient (According to National Early Warning Score (NEWS Scale)) | Days 1 - 29. | 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. | days | MEAN |
| SECONDARY | Number of Patients Requiring Supplementary Oxygen | Days intervals 1 (baseline), 3, 5, 8, 11, 15, 29. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Hospitalisation Duration | Days 1 - 29 | 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. | days | MEAN |
| SECONDARY | Mortality | Days 1 - 29. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Number of Participants With Serious Adverse Events | Days 1 - 29. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Number of Participants With Adverse Events | Days 1 - 29. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Discontinuation of Drug Administration | Days 1 - 17. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Status of the Patient (According to 7-point Ordinal Scale) | Adult Patients Hospitalized With COVID-19 | 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) | Adult Patients Hospitalized With COVID-19 | 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) | Adult Patients Hospitalized With COVID-19 | 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) | Adult Patients Hospitalized With COVID-19 | 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) | Adult Patients Hospitalized With COVID-19 | 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) | Adult Patients Hospitalized With COVID-19 | 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) | Adult Patients Hospitalized With COVID-19 | Number of patients at Baseline (Day 1) / 7. Death | 0 | Participants | |
| Clinical Status of the Patient (According to 7-point Ordinal Scale) | Adult Patients Hospitalized With COVID-19 | 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) | Adult Patients Hospitalized With COVID-19 | 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) | Adult Patients Hospitalized With COVID-19 | Number of patients on Day 15 / 3. Hospitalized, not requiring supplemental oxygen | 37 | Participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adult Patients Hospitalized With COVID-19 | 81 | |
| Overall Study | COMPLETED | Adult Patients Hospitalized With COVID-19 | 81 | |
| Overall Study | NOT COMPLETED | Adult Patients Hospitalized With COVID-19 | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | PQ interval prolonged / Electrocardiogram PR prolongation* | Investigations | Adult Patients Hospitalized With COVID-19 | 2 | 81 | 2 |
| other | Fever (Intermittent fever included) / Pyrexia | General disorders | Adult Patients Hospitalized With COVID-19 | 3 | 81 | 3 |
| other | Pneumonia bacterial | Infections and infestations | Adult Patients Hospitalized With COVID-19 | 1 | 81 | 1 |
| serious | Klebsiella sepsis | Infections and infestations | Adult Patients Hospitalized With COVID-19 | 1 | 81 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adult Patients Hospitalized With COVID-19 | 0 | 81 |
| Total, other adverse events | Adult Patients Hospitalized With COVID-19 | 6 | 81 |
| Total, serious adverse events | Adult Patients Hospitalized With COVID-19 | 1 | 81 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04542226
GET https://conductscience.org/api/trials/v1/NCT04542226/results?page=2