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Infections, CoronavirusPhase 2/3NCT04381377

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

A Phase 2/3 study testing azoximer bromide in people with Infections, Coronavirus, run by NPO Petrovax at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Infections, Coronavirus
What is being tested?
azoximer bromide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
394 participants
Where
14 sitesin 2 countries
Study dates
28 Apr 2020to 23 Apr 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

Russia12 sites

  • Regional state budgetary institution of public health "City hospital No. 5 of Barnaul"

    Barnaul, 656045

  • Central Research Institute of Epidemiology of Rospotrebnadzor

    Moscow, 111123

  • 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, 111539

  • Moscow State Budgetary Healthcare Institution "Infectious Clinical Hospital No. 1 of the Moscow Department of Healthcare"

    Moscow, 125367

  • Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 24 of the Moscow Department of Healthcare"

    Moscow, 127015

  • State budgetary institution "Research Institute of Emergency Care named after N.V. Sklifosovsky in Department of Health of the city of Moscow"

    Moscow, 129090

  • Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 40 of the Moscow Department of Healthcare"

    Moscow, 129301

  • State budgetary institution of health care of the Nizhny Novgorod region "Infectious clinical hospital No. 2 of Nizhny Novgorod"

    Nizhny Novgorod, 603022

  • Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Health of the Russian Federation

    Orenburg, 460000

  • Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after Academician I.P. Pavlov

    Saint Petersburg, 197022

  • State budgetary health institution of the Vladimir region "Regional Clinical Hospital"

    Vladimir, 600023

  • Yaroslavl State Medical University of Ministry of Health of the Russian Federation

    Yaroslavl, 150000

Other trials in Russia

Slovakia2 sites

  • Clinics of Infectious Diseases, University Hospital in Nitra

    Nitra, 949 01

  • Clinics of Infectious Diseases, University Hospital in Trnava

    Trnava, 917 74

Other trials in Slovakia

About this study

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).

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.

Read the 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).

Being tested
azoximer bromide, Placebo
Keywords
COVID-19
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • azoximer bromideDrug

    Also called Polyoxidonium

    Investigational medicinal product

  • PlaceboOther

    Placebo

Study groups in NCT04381377
Study groupRoleWhat they receive
PolyoxidoniumExperimentalPolyoxidonium 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).
Receives: Drug: azoximer bromide
PlaceboPlacebo comparatorPlacebo 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).
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 15

Secondary outcomes (5)

  1. 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.

    Measured: Clinical status of the patient and the average change in the ordinal scale from baseline, both on days 3, 5, 8, 11, 29.

  2. NEWS

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

    Change in NEWS from baseline.

    Measured: Change in NEWS from baseline on days 3, 5, 8, 11, 15, 29.

  3. Oxygenation

    Oxygenation free days. Incidence and duration of new oxygen use.

    Measured: Oxygenation free days in the first 28 days (to day 29). Incidence and duration of new oxygen use during the study.

  4. Mechanical Ventilation

    Ventilator free days. Incidence and duration of new mechanical ventilation use.

    Measured: Ventilator free days in the first 28 days (to day 29). Incidence and duration of new mechanical ventilation use during the trial.

  5. Mortality

    Measured: 28-day mortality

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2020
  2. Study start28 Apr 2020
  3. Primary completion3 Mar 2021
  4. Study completion23 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
394 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04381377
Sponsor's protocol ID
PО-COV-III-20
Status last verified
Aug 2024
First submitted
7 May 2020
Last updated
23 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing azoximer bromide in people with Infections, Coronavirus, run by NPO Petrovax at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Russia, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical status of the patient (according to 7-point ordinal scale) (time frame: Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04381377.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.

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