Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19

NPO Petrovax

Status: Completed

Conditions: Infections, Coronavirus

Treatments: Drug: Polyoxidonium

Study type: Observational

Funder types: Industry

Identifiers

NCT04542226

Covid_v_1.0

Details and patient eligibility

About

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).

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

81 participants in 1 patient group

Adult patients hospitalized with COVID-19

Description:

Patients eligible for enrollment into the study

Treatment:

Drug: Polyoxidonium