Overview
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.
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 293 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...293).
Haematology and blood chemistry tests will be performed at day -1 and days 1,3, 8 1, 171.
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 293.
The safety and tolerability will be evaluated throughout the study (from signing the Informed Consent Form to the study completion visit).
Eligibility
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.