N/A
N=81
Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19
Infections, Coronavirus
Bottom Line
View on ClinicalTrials.gov: NCT04542226 ↗Enrolled (actual)
81
Serious AEs
1.2%
Results posted
Dec 2020
Primary outcome: Primary: Clinical Status of the Patient (According to 7-point Ordinal Scale) — 0; 0; 22; 24 Participants — p=<0.0000001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Polyoxidonium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NPO Petrovax
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Status of the Patient (According to 7-point Ordinal Scale) |
0; 0; 22; 24; 24; 11 | <0.0000001 sig |
| SECONDARY Time to Improvement in Clinical Status of the Patient (According to Ordinal Scale) by 1 Point for Each OS Score |
13.77 | — |
| SECONDARY Clinical Status of the Patient (According to National Early Warning Score (NEWS Scale)) |
8.85 | — |
| SECONDARY Number of Patients Requiring Supplementary Oxygen |
59; 22; 58; 23; 56; 25 | — |
| SECONDARY Hospitalisation Duration |
19.13 | — |
| SECONDARY Mortality |
81; 0 | — |
| SECONDARY The Number of Participants With Serious Adverse Events |
1 | — |
| SECONDARY The Number of Participants With Adverse Events |
7 | — |
| SECONDARY Number of Participants With Discontinuation of Drug Administration |
1; 2 | — |
Summary
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).
Eligibility Criteria
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:
- severe disease: mechanical ventilation or oxygen supply required with blood oxygen saturation (SpO2) ≤ 94% on room air or tachypnea, respiratory rate ≥ 24 breaths per minute,
- mild-moderate disease: SpO2 > 94% on room air or respiratory rate < 24 breaths per minute.
- 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
- Pregnancy or breastfeeding.
- Pathological condition that the study doctor considers significant enough to prevent enrolment of this patient.
- Participation in any clinical study within 30 days before the Informed Consent form provided.
- Hypersensitivity and/or intolerability to any ingredient of the investigational product.
- Acute or chronic renal failure.
Data sourced from ClinicalTrials.gov (NCT04542226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.