Back to resultsEfficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19
Primary Purpose
Infections, Coronavirus
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
azoximer bromide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Infections, Coronavirus focused on measuring COVID-19
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Regional state budgetary institution of public health "City hospital No. 5 of Barnaul"
- Central Research Institute of Epidemiology of Rospotrebnadzor
- 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 State Budgetary Healthcare Institution "Infectious Clinical Hospital No. 1 of the Moscow Department of Healthcare"
- Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 24 of the Moscow Department of Healthcare"
- State budgetary institution "Research Institute of Emergency Care named after N.V. Sklifosovsky in Department of Health of the city of Moscow"
- Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 40 of the Moscow Department of Healthcare"
- State budgetary institution of health care of the Nizhny Novgorod region "Infectious clinical hospital No. 2 of Nizhny Novgorod"
- Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
- Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after Academician I.P. Pavlov
- State budgetary health institution of the Vladimir region "Regional Clinical Hospital"
- Yaroslavl State Medical University of Ministry of Health of the Russian Federation
- Clinics of Infectious Diseases, University Hospital in Nitra
- Clinics of Infectious Diseases, University Hospital in Trnava
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Polyoxidonium
Placebo
Arm Description
Polyoxidonium will be administered in the dose of 12 mg (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections).
Placebo will be administered (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections).
Outcomes
Primary Outcome Measures
Clinical status of the patient (according to 7-point ordinal scale)
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 Outcome Measures
Clinical status of the patient (according to 7-point ordinal scale)
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.
NEWS
The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first.
Change in NEWS from baseline.
Oxygenation
Oxygenation free days. Incidence and duration of new oxygen use.
Mechanical Ventilation
Ventilator free days. Incidence and duration of new mechanical ventilation use.
Mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04381377
Brief Title
Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19
Official Title
A Multi-centre, Adaptive, Randomized, Double-blind, Placebo-controlled Comparative Clinical Study of the Safety and Efficacy of Polyoxidonium®, Lyophilizate for Solution for Injections and Topical Application, 6 mg (NPO Petrovax Pharm LLC, Russia) in Patients With Coronavirus Disease (COVID-19).
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 29, 2020 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NPO Petrovax
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 coronavirus disease (COVID-19). This is a multicentre prospective, randomized, double-blind, placebo-controlled, parallel-group phase IIb\IIIa clinical trial.
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 injections and topical application, 6 mg over placebo in hospitalized patients with coronavirus disease (COVID-19). A study will last for 29±3 days (maximum) for each participant and will include: screening (days -1...1); treatment period (17 days in total, days 1...17) with the administration of the investigational product Polyoxidonium/placebo (intravenous injections for 3 days, then intramuscular injections for 14 days), assessment of the clinical status, recording of AEs; follow-up period (days 18...29±3).
Haematology and blood chemistry tests will be performed at day -1 and days 1,3, 8 ±1, 17±1.
Assessment of the clinical status according to the 7-point ordinal scale and according to the National Early Warning Score (NEWS) scale will be done every day during hospitalization from day 1 up to and including day 17 and at the follow-up on day 29±3.
The safety and tolerability will be evaluated throughout the study (from signing the Informed Consent Form to the study completion visit).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Coronavirus
Keywords
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
394 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polyoxidonium
Arm Type
Experimental
Arm Description
Polyoxidonium will be administered in the dose of 12 mg (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections).
Intervention Type
Drug
Intervention Name(s)
azoximer bromide
Other Intervention Name(s)
Polyoxidonium
Intervention Description
Investigational medicinal product
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Clinical status of the patient (according to 7-point ordinal scale)
Description
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.
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Clinical status of the patient (according to 7-point ordinal scale)
Description
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.
Time Frame
Clinical status of the patient and the average change in the ordinal scale from baseline, both on days 3, 5, 8, 11, 29.
Title
NEWS
Description
The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first.
Change in NEWS from baseline.
Time Frame
Change in NEWS from baseline on days 3, 5, 8, 11, 15, 29.
Title
Oxygenation
Description
Oxygenation free days. Incidence and duration of new oxygen use.
Time Frame
Oxygenation free days in the first 28 days (to day 29). Incidence and duration of new oxygen use during the study.
Title
Mechanical Ventilation
Description
Ventilator free days. Incidence and duration of new mechanical ventilation use.
Time Frame
Ventilator free days in the first 28 days (to day 29). Incidence and duration of new mechanical ventilation use during the trial.
Title
Mortality
Time Frame
28-day mortality
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Francois Rossi, Professor
Organizational Affiliation
University of Montpellier (Faculté de Médecine) and Institute Sainte Catherine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional state budgetary institution of public health "City hospital No. 5 of Barnaul"
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Central Research Institute of Epidemiology of Rospotrebnadzor
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
The state healthcare institution of the city of Moscow "City Clinical Hospital No. 15 named after OM Filatov" in "Moscow City Department of Health"
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Moscow State Budgetary Healthcare Institution "Infectious Clinical Hospital No. 1 of the Moscow Department of Healthcare"
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 24 of the Moscow Department of Healthcare"
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
State budgetary institution "Research Institute of Emergency Care named after N.V. Sklifosovsky in Department of Health of the city of Moscow"
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 40 of the Moscow Department of Healthcare"
City
Moscow
ZIP/Postal Code
129301
Country
Russian Federation
Facility Name
State budgetary institution of health care of the Nizhny Novgorod region "Infectious clinical hospital No. 2 of Nizhny Novgorod"
City
Nizhny Novgorod
ZIP/Postal Code
603022
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after Academician I.P. Pavlov
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
State budgetary health institution of the Vladimir region "Regional Clinical Hospital"
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Yaroslavl State Medical University of Ministry of Health of the Russian Federation
City
Yaroslavl
ZIP/Postal Code
150000
Country
Russian Federation
Facility Name
Clinics of Infectious Diseases, University Hospital in Nitra
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Clinics of Infectious Diseases, University Hospital in Trnava
City
Trnava
ZIP/Postal Code
917 74
Country
Slovakia
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19
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