Status:
COMPLETED
Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19
Lead Sponsor:
NPO Petrovax
Conditions:
Infections, Coronavirus
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to demonstrate the superiority of Polyoxidonium®, lyophilizate for solution for injections and topical application, 6 mg over placebo in hospitalized patients with coronav...
Detailed Description
This is a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group phase 3 IIb\\IIIa trial to evaluate the efficacy of Polyoxidonium®, lyophilizate for solution for inject...
Eligibility Criteria
Inclusion
- Male and female patients from 18 to 85 years of age.
- The patient (or his/her legal representative, if the patient is not able to sign the form) signed an Informed Consent form for participation in this study before any initiation of any study procedures.
- The patient can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol.
- Confirmed diagnosis of coronavirus disease (COVID-19): laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen \< 14 days prior to randomization.
- Illness (coronavirus disease COVID-19) of any duration, and at least one of the following:
- Radiographic/tomographic chest infiltrates by imaging (chest x-ray, CT scan, etc.), OR
- Evidence of rales/crackles on clinical exam AND SpO2 ≤ 94% on room air, OR
- Indications for mechanical ventilation and/or supplemental oxygen.
- Agrees to use adequate contraception methods (the methods with at least 90% efficacy include non-hormonal intrauterine devices; condom with intravaginal spermicide; cervical caps
Exclusion
- History of clinically significant allergic reactions.
- Hypersensitivity and/or intolerability to any ingredient of the investigational product or placebo.
- Anticipated transfer to another hospital which is not a study centre within the next 72 hours.
- Acute or chronic renal failure.
- History of HIV infection, tuberculosis.
- Conditions associated with primary immunodeficiency.
- Concomitant use of cytostatic medications to treat a concomitant disease.
- Systemic connective tissue diseases.
- Need for the prohibited medications.
- Administration of medications that are prohibited or unauthorized by the protocol within 2 weeks before the expected randomization date.
- History of alcohol or drug dependence.
- History of malignant tumours of any location with remission for less than 2 years.
- History of psychic (including depressive) disorders, physical and other factors that do not allow for adequate self-assessment of one's behaviour and for compliance with the protocol requirements, including history of psychiatric disorders.
- Pregnancy or breastfeeding.
- Intravenous injections and/or sampling of the required amount of blood is not possible.
- Positive pregnancy test (in patients with childbearing potential).
- Participation in any clinical study within 3 months before enrolment in this study.
- History of any condition that the study doctor considers significant enough to prevent enrolment of this patient.
Key Trial Info
Start Date :
April 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2021
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT04381377
Start Date
April 28 2020
End Date
April 23 2021
Last Update
August 23 2024
Active Locations (14)
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1
Regional state budgetary institution of public health "City hospital No. 5 of Barnaul"
Barnaul, Russia, 656045
2
Central Research Institute of Epidemiology of Rospotrebnadzor
Moscow, Russia, 111123
3
The state healthcare institution of the city of Moscow "City Clinical Hospital No. 15 named after OM Filatov" in "Moscow City Department of Health"
Moscow, Russia, 111539
4
Moscow State Budgetary Healthcare Institution "Infectious Clinical Hospital No. 1 of the Moscow Department of Healthcare"
Moscow, Russia, 125367