A multi-centre, adaptive, randomized, double-blind, placebo-controlled comparative clinical study of the safety and efficacy of 12 mg Polyoxidonium®, lyophilizate solution for injections (NPO Petrovax Pharm LLC, Russia) in patients with coronavirus disease (COVID-19).

A multi-centre, adaptive, randomized, double-blind, placebo-controlled comparative clinical trial of the safety and efficacy of 12 mg Polyoxidonium®, lyophilizate solution for injections (NPO Petrovax Pharm LLC, Russia), in patients with coronavirus disease (COVID-19)

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001782-37-SK

Enrollment

464

Registered

2020-06-15

Start date

2020-11-07

Completion date

Unknown

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 21.1 Level: PT Classification code 10035737 Term: Pneumonia viral System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Polyoxidonium Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: Azoximer bromide CAS Number: 0892497-01-7 Current Sponsor code: Polyoxidonium® (azoximer bro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hospitalized (at the time of recruitment) male and female patients from 18 to 85 years of age. 2. 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. 3. The patient (or his/her legal representative, if the patient is not able to sign the form) can understand all protocol requirements, perform the study procedures, and agree to all limitations specified in the protocol. 4. 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 =65 years) yes F.1.3.1 Number of subjects for this age range 227

Exclusion criteria

Exclusion criteria: 1. History of clinically significant allergic reactions. 2. Hypersensitivity and/or intolerability to any ingredient of the investigational product or placebo. 3. Anticipated transfer to another hospital which is not a study centre within the next 72 hours. 4. Acute or chronic renal failure. 5. History of HIV infection, tuberculosis. 6. Conditions associated with primary immunodeficiency, established by assessing the history and by interviewing the patient.. 7. Concomitant use of medications cytostatic drugs (including but not limited to alkylating agents, platinum analogues, dna intercalating agents, anticancer antibiotics, mitosisinhibitors, taxanes, topoisomerase inhibitors, antimetabolites) to treat a concomitant disease. 8. Systemic connective tissue diseases. 9. Need for the prohibited medications that are not part of the locally/internationally approved treatment of COVID-19. 10. Administration of convalescent plasma or intravenous immunoglobulin (IVIg) for coronavirus disease COVID-19 therapy ever. 11. Administration of any live vaccine within 4 weeks before screening or intending to receive a live vaccine during the study. 12. Administration of medications that are prohibited or unauthorized by the protocol within 2 weeks before the expected randomization date. 13. Administration or intending to receive an extracorporeal blood purification (EBP) device to remove pro-inflammatory cytokines from the blood, such as a cytokine filtering or absorption device (for example, CytoSorb ®). 14. History of alcohol or drug dependence. 15. History of malignant tumours of any location with remission for less than 2 years. 16. 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. 17. Pregnancy or breastfeeding. 18. IV injections and/or sampling of the required amount of blood is not possible. 19. Positive pregnancy test (in patients with childbearing potential). 20. Participation in any clinical study within 30 days before enrolment in this study. 21. History of any condition that the study doctor considers significant enough to prevent enrolment of this patient.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess safety and efficacy of Polyoxidonium®, lyophilizate solution for injections in dose of 12 mg (NPO Petrovax Pharm LLC, Russia) in comparison with placebo in hospitalized patients with coronavirus disease (COVID-19). ;Secondary Objective: 1. To evaluate clinical efficacy of Polyoxidonium®, lyophilizate solution for injections in dose of 12 mg (NPO Petrovax Pharm LLC, Russia) compared to placebo in hospitalized adult patients with COVID-19. 2. To evaluate safety of Polyoxidonium®, lyophilizate solution for injections in dose of 12 mg (NPO Petrovax Pharm LLC, Russia) compared to placebo in hospitalized adult patients with COVID-19. Additional objective of part 1 of the study. To define the primary efficacy endpoint for subsequent assessment of efficacy of Polyoxidonium®, lyophilizate solution for injections in dose of 12 mg (NPO Petrovax Pharm LLC, Russia) in patients with COVID-19.;Primary end point(s): The initial primary efficacy outcome is clinical status of the patient at Day 15 based on a 7-point ordinal scale: 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death.;Timepoint(s) of evaluation of this end point: The endpoint methodology is taken from the WHO Master Protocol, which recommends an initial primary end-point for the Phase IIb part of the study that is then updated after a blinded interim analysis (after 100 patients have been recruited) for the Phase III part of the study (1) . According to WHO Master Protocol, it was planned that the primary endpoint (clinical status on the ordinal scale) would be evaluated on day 15 during the first part of the study. The day of the primary endpoint could be modified based on a blinded evaluation of the primary eff	—

Measure

Time frame

Main Objective: To assess safety and efficacy of Polyoxidonium®, lyophilizate solution for injections in dose of 12 mg (NPO Petrovax Pharm LLC, Russia) in comparison with placebo in hospitalized patients with coronavirus disease (COVID-19). ;Secondary Objective: 1. To evaluate clinical efficacy of Polyoxidonium®, lyophilizate solution for injections in dose of 12 mg (NPO Petrovax Pharm LLC, Russia) compared to placebo in hospitalized adult patients with COVID-19. 2. To evaluate safety of Polyoxidonium®, lyophilizate solution for injections in dose of 12 mg (NPO Petrovax Pharm LLC, Russia) compared to placebo in hospitalized adult patients with COVID-19. Additional objective of part 1 of the study. To define the primary efficacy endpoint for subsequent assessment of efficacy of Polyoxidonium®, lyophilizate solution for injections in dose of 12 mg (NPO Petrovax Pharm LLC, Russia) in patients with COVID-19.;Primary end point(s): The initial primary efficacy outcome is clinical status of the patient at Day 15 based on a 7-point ordinal scale: 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death.;Timepoint(s) of evaluation of this end point: The endpoint methodology is taken from the WHO Master Protocol, which recommends an initial primary end-point for the Phase IIb part of the study that is then updated after a blinded interim analysis (after 100 patients have been recruited) for the Phase III part of the study (1) . According to WHO Master Protocol, it was planned that the primary endpoint (clinical status on the ordinal scale) would be evaluated on day 15 during the first part of the study. The day of the primary endpoint could be modified based on a blinded evaluation of the primary eff

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Secondary

Measure	Time frame
Secondary end point(s): • Clinical status on the 7-point ordinal scale: o Clinical status - Days 3, 5, 8, 11 and 29. o Time to improvement in clinical status by one category from admission - Day 1 (baseline) then every day up to and including day 17. o Change in clinical status from baseline - Days 1 (baseline), 3, 5, 8, 11, 15, and 29. • Clinical status on the National Early Warning Score (NEWS): o The time to discharge or to a NEWS of = 2 and maintained for 24 hours, whichever occurs first - Every day up to and including day 17. o Change in NEWS from baseline - Days 1 (baseline), 3, 5, 8, 11, 15, and 29 • Oxygenation: o Oxygenation free days in the first 28 days (on Day 29). o Incidence and duration of new oxygen use during the study (on Day 29). • Mechanical Ventilation: o Ventilator free days in the first 28 days (on Day 29). o Incidence and duration of new mechanical ventilation use during the trial (on Day 29). • Hospitalization: o Duration of hospitalization (days) - on Day 29. • Mortality: o 28-day mortality - on Day 29. ;Timepoint(s) of evaluation of this end point: • 7-point ordinal scale: o Clinical status - Days 3, 5, 8, 11 and 29 o Time to improvement - Day 1 (baseline) then every day up to and including day 17 o Change in clinical status from baseline - Days 1, 3, 5, 8, 11, 15, and 29 • NEWS: o The time to discharge or to a NEWS of = 2 and maintained for 24 hours, whichever occurs first - Every day up to and including day 17 o Change in NEWS from baseline - Days 1, 3, 5, 8, 11, 15, and 29 • Oxygenation: o Oxygenation free days in the first 28 days (Day 29) o Incidence and duration of new oxygen use (on Day 29) • Mechanical Ventilation: o Ventilator free days in the first 28 days (Day 29) o Incidence and duration of new mechanical ventilation use (on Day 29) • Hospitalization - Day 29 • Mortality - Day 29	—

Measure

Time frame

Secondary end point(s): • Clinical status on the 7-point ordinal scale: o Clinical status - Days 3, 5, 8, 11 and 29. o Time to improvement in clinical status by one category from admission - Day 1 (baseline) then every day up to and including day 17. o Change in clinical status from baseline - Days 1 (baseline), 3, 5, 8, 11, 15, and 29. • Clinical status on the National Early Warning Score (NEWS): o The time to discharge or to a NEWS of = 2 and maintained for 24 hours, whichever occurs first - Every day up to and including day 17. o Change in NEWS from baseline - Days 1 (baseline), 3, 5, 8, 11, 15, and 29 • Oxygenation: o Oxygenation free days in the first 28 days (on Day 29). o Incidence and duration of new oxygen use during the study (on Day 29). • Mechanical Ventilation: o Ventilator free days in the first 28 days (on Day 29). o Incidence and duration of new mechanical ventilation use during the trial (on Day 29). • Hospitalization: o Duration of hospitalization (days) - on Day 29. • Mortality: o 28-day mortality - on Day 29. ;Timepoint(s) of evaluation of this end point: • 7-point ordinal scale: o Clinical status - Days 3, 5, 8, 11 and 29 o Time to improvement - Day 1 (baseline) then every day up to and including day 17 o Change in clinical status from baseline - Days 1, 3, 5, 8, 11, 15, and 29 • NEWS: o The time to discharge or to a NEWS of = 2 and maintained for 24 hours, whichever occurs first - Every day up to and including day 17 o Change in NEWS from baseline - Days 1, 3, 5, 8, 11, 15, and 29 • Oxygenation: o Oxygenation free days in the first 28 days (Day 29) o Incidence and duration of new oxygen use (on Day 29) • Mechanical Ventilation: o Ventilator free days in the first 28 days (Day 29) o Incidence and duration of new mechanical ventilation use (on Day 29) • Hospitalization - Day 29 • Mortality - Day 29

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Countries

Brazil, France, Italy, Poland, Romania, Russian Federation, Slovakia

Contacts

Public ContactPVX Clinical Trials Information

NPO Petrovax Pharm, LLC

dodonovns@petrovax.ru+7495730-75-45*125

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026