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.
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).
Drug: azoximer bromide
Investigational medicinal product
Other Name: Polyoxidonium
Other: Placebo
Placebo
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.
Regional state budgetary institution of public health "City hospital No. 5 of Barnaul"
Barnaul, Russian Federation
Central Research Institute of Epidemiology of Rospotrebnadzor
Moscow, Russian Federation
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, Russian Federation
Moscow State Budgetary Healthcare Institution "Infectious Clinical Hospital No. 1 of the Moscow Department of Healthcare"
Moscow, Russian Federation
Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 24 of the Moscow Department of Healthcare"
Moscow, Russian Federation
State budgetary institution "Research Institute of Emergency Care named after N.V. Sklifosovsky in Department of Health of the city of Moscow"
Moscow, Russian Federation
Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 40 of the Moscow Department of Healthcare"
Moscow, Russian Federation
State budgetary institution of health care of the Nizhny Novgorod region "Infectious clinical hospital No. 2 of Nizhny Novgorod"
Nizhny Novgorod, Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
Orenburg, Russian Federation
Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after Academician I.P. Pavlov
Saint Petersburg, Russian Federation
State budgetary health institution of the Vladimir region "Regional Clinical Hospital"
Vladimir, Russian Federation
Yaroslavl State Medical University of Ministry of Health of the Russian Federation
Yaroslavl, Russian Federation
Clinics of Infectious Diseases, University Hospital in Nitra
Nitra, Slovakia
Clinics of Infectious Diseases, University Hospital in Trnava
Trnava, Slovakia
Jean-Francois Rossi, Professor, Principal Investigator
University of Montpellier (Faculté de Médecine) and Institute Sainte Catherine