Trial · NCT04381377
Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19
NCT04381377, Phase 2, Phase 3, Completed, NPO Petrovax
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19. Trials, record NCT04381377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04381377
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19
- NCT number
- NCT04381377
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 394 participants, actual
- Lead sponsor
- NPO Petrovax
- Conditions
- Infections, Coronavirus
- Interventions
- azoximer bromide, Placebo
- First posted
- 2020-05-08
- Last updated
- 2024-08-23
Source ClinicalTrials.gov
Registered outcomes6
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 15 | The primary efficacy outcome will be defined based on the blinded analysis of data of the first 100 patients in the 1st part of the study. There is uncertainty about the clinical course and potential different trajectories according to baseline disease severity, so the day of the primary endpoint may be modified based on a blinded evaluation of the primary efficacy outcome in various days. |
| Secondary | Clinical status of the patient (according to 7-point ordinal scale) | Clinical status of the patient and the average change in the ordinal scale from baseline, both on days 3, 5, 8, 11, 29. | Time to improvement by one category from admission on the ordinal scale. Clinical status of the patient. Average change in the ordinal scale from baseline. |
| Secondary | NEWS | Change in NEWS from baseline on days 3, 5, 8, 11, 15, 29. | The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. Change in NEWS from baseline. |
| Secondary | Oxygenation | Oxygenation free days in the first 28 days (to day 29). Incidence and duration of new oxygen use during the study. | Oxygenation free days. Incidence and duration of new oxygen use. |
| Secondary | Mechanical Ventilation | Ventilator free days in the first 28 days (to day 29). Incidence and duration of new mechanical ventilation use during the trial. | Ventilator free days. Incidence and duration of new mechanical ventilation use. |
| Secondary | Mortality | 28-day mortality |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT04381377
GET https://conductscience.org/api/trials/v1/NCT04381377/registered