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Efficacy and Safety of Polyoxidonium® in Hospitalized Patients With Coronavirus Disease COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381377
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
NPO Petrovax

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.

Condition or disease Intervention/treatment Phase
Infections, Coronavirus Drug: azoximer bromide Other: Placebo Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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).
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Polyoxidonium
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).
Drug: azoximer bromide
Investigational medicinal product
Other Name: Polyoxidonium

Placebo Comparator: Placebo
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).
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Clinical status of the patient (according to 7-point ordinal scale) [ Time Frame: Day 15 ]
    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 :
  1. Clinical status of the patient (according to 7-point ordinal scale) [ 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. ]
    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.

  2. NEWS [ Time Frame: Change in NEWS from baseline on days 3, 5, 8, 11, 15, 29. ]

    The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first.

    Change in NEWS from baseline.


  3. Oxygenation [ Time Frame: Oxygenation free days in the first 28 days (to day 29). Incidence and duration of new oxygen use during the study. ]
    Oxygenation free days. Incidence and duration of new oxygen use.

  4. Mechanical Ventilation [ Time Frame: Ventilator free days in the first 28 days (to day 29). Incidence and duration of new mechanical ventilation use during the trial. ]
    Ventilator free days. Incidence and duration of new mechanical ventilation use.

  5. Mortality [ Time Frame: 28-day mortality ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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 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 < 14 days prior to randomization.
  5. 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.
  6. 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:

  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.
  7. Concomitant use of cytostatic medications to treat a concomitant disease.
  8. Systemic connective tissue diseases.
  9. Need for the prohibited medications.
  10. Administration of medications that are prohibited or unauthorized by the protocol within 2 weeks before the expected randomization date.
  11. History of alcohol or drug dependence.
  12. History of malignant tumours of any location with remission for less than 2 years.
  13. 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.
  14. Pregnancy or breastfeeding.
  15. Intravenous injections and/or sampling of the required amount of blood is not possible.
  16. Positive pregnancy test (in patients with childbearing potential).
  17. Participation in any clinical study within 3 months before enrolment in this study.
  18. History of any condition that the study doctor considers significant enough to prevent enrolment of this patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04381377


Contacts
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Contact: Nikolay Dodonov +7 (495) 730-75-45 ext 125 dodonovns@petrovax.ru

Locations
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Russian Federation
Regional state budgetary institution of public health "City hospital No. 5 of Barnaul" Not yet recruiting
Barnaul, Russian Federation, 656045
Contact: A. A. Grebenyuk         
Central Research Institute of Epidemiology of Rospotrebnadzor Not yet recruiting
Moscow, Russian Federation, 111123
Contact: A. A. Ploskireva         
The state healthcare institution of the city of Moscow "City Clinical Hospital No. 15 named after OM Filatov" in "Moscow City Department of Health" Not yet recruiting
Moscow, Russian Federation, 111539
Contact: I. G. Gordeev         
Moscow State Budgetary Healthcare Institution "Infectious Clinical Hospital No. 1 of the Moscow Department of Healthcare" Not yet recruiting
Moscow, Russian Federation, 125367
Contact: L. V. Kolobukhina         
Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 24 of the Moscow Department of Healthcare" Not yet recruiting
Moscow, Russian Federation, 127015
Contact: S. K. Zyryanov         
State budgetary institution "Research Institute of Emergency Care named after N.V. Sklifosovsky in Department of Health of the city of Moscow" Not yet recruiting
Moscow, Russian Federation, 129090
Contact: V. V. Kulabukhov         
Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 40 of the Moscow Department of Healthcare" Not yet recruiting
Moscow, Russian Federation, 129301
Contact: D. N. Protsenko         
State budgetary institution of health care of the Nizhny Novgorod region "Infectious clinical hospital No. 2 of Nizhny Novgorod" Recruiting
Nizhny Novgorod, Russian Federation, 603022
Contact: E. G. Tikhomolova    +7-831-2882-32-72    mlpukib2@mail.ru   
Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Health of the Russian Federation Not yet recruiting
Orenburg, Russian Federation, 460000
Contact: A. S. Pankov         
Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after Academician I.P. Pavlov Not yet recruiting
Saint Petersburg, Russian Federation, 197022
Contact: D. A. Lioznov         
State budgetary health institution of the Vladimir region "Regional Clinical Hospital" Not yet recruiting
Vladimir, Russian Federation, 600023
Contact: M. V. Smirnov         
Yaroslavl State Medical University of Ministry of Health of the Russian Federation Not yet recruiting
Yaroslavl, Russian Federation, 150000
Contact: I. G. Sitnikov         
Sponsors and Collaborators
NPO Petrovax
Investigators
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Principal Investigator: Jean-Francois Rossi, Professor University of Montpellier (Faculté de Médecine) and Institute Sainte Catherine
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Responsible Party: NPO Petrovax
ClinicalTrials.gov Identifier: NCT04381377    
Other Study ID Numbers: PО-COV-III-20
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NPO Petrovax:
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Bromides
Anticonvulsants