Clinical trial NCT04542226: Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19
Official title: Open Observational Study of Efficacy and Safety of Polyoxidonium in Complex Therapy of Hospitalized Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Coronavirus
Lead sponsor: NPO Petrovax
Sponsor class: INDUSTRY
First posted: 2020-09-09
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. The hospitalized patient was administered Polyoxidonium, according to the instruction for medical usage in complex with Russian MoH guidance for treatment of COVID-19.
2. 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.
3. The patient signed an Informed Consent form for participation in this study.
4. The patient can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol.
5. Male and female patients from 18 years of age.
6. 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:

1. Pregnancy or breastfeeding.
2. Pathological condition that the study doctor considers significant enough to prevent enrolment of this patient.
3. Participation in any clinical study within 30 days before the Informed Consent form provided.
4. Hypersensitivity and/or intolerability to any ingredient of the investigational product.
5. Acute or chronic renal failure.

Primary outcomes:
measure: Clinical Status of the Patient (According to 7-point Ordinal Scale)
timeFrame: Day 1 (Baseline), Day 15
Secondary outcomes:
measure: Time to Improvement in Clinical Status of the Patient (According to Ordinal Scale) by 1 Point for Each OS Score
timeFrame: Days 1 - 29.
measure: Clinical Status of the Patient (According to National Early Warning Score (NEWS Scale))
timeFrame: Days 1 - 29.
measure: Number of Patients Requiring Supplementary Oxygen
timeFrame: Days intervals 1 (baseline), 3, 5, 8, 11, 15, 29.
measure: Hospitalisation Duration
timeFrame: Days 1 - 29
measure: Mortality
timeFrame: Days 1 - 29.
measure: The Number of Participants With Serious Adverse Events
timeFrame: Days 1 - 29.
measure: The Number of Participants With Adverse Events
timeFrame: Days 1 - 29.
measure: Number of Participants With Discontinuation of Drug Administration
timeFrame: Days 1 - 17.
Other outcomes:
Locations:
city: Grodno
country: Belarus
facility: Healthcare Institution "Grodno Regional Infectious Clinical Hospital"
city: Cheboksary
country: Russian Federation
facility: State-Funded Healthcare Institution "Emergency Hospital" of Ministry of Health of Chuvash Republic
state: Chuvashia
city: Novorossiysk
country: Russian Federation
facility: State-Funded Healthcare Institution "Infectious Disease Hospital No.3" of Ministry of Health of Krasnodar Krai
state: Krasnodar Krai
city: Yoshkar-Ola
country: Russian Federation
facility: State-Funded Institution of Mari El Republic "Yoshkar-Ola City Hospital"
state: Mari El Republic
city: Novaya Usman
country: Russian Federation
facility: State-Funded Healthcare Institution of Voronezh Region "Novaya Usman District Hospital"
state: Voronezh Region
Study officials:
affiliation: NPO Petrovax
name: Nikolay S. Dodonov
role: STUDY_CHAIR
References: