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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
394
Investigational medicinal product
Placebo
Regional state budgetary institution of public health "City hospital No. 5 of Barnaul"
Barnaul, Russia
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.
Time frame: Day 15
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.
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.
NEWS
The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. Change in NEWS from baseline.
Time frame: Change in NEWS from baseline on days 3, 5, 8, 11, 15, 29.
Oxygenation
Oxygenation free days. Incidence and duration of new oxygen use.
Time frame: Oxygenation free days in the first 28 days (to day 29). Incidence and duration of new oxygen use during the study.
Mechanical Ventilation
Ventilator free days. Incidence and duration of new mechanical ventilation use.
Time frame: Ventilator free days in the first 28 days (to day 29). Incidence and duration of new mechanical ventilation use during the trial.
Mortality
Time frame: 28-day mortality
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Central Research Institute of Epidemiology of Rospotrebnadzor
Moscow, Russia
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, Russia
Moscow State Budgetary Healthcare Institution "Infectious Clinical Hospital No. 1 of the Moscow Department of Healthcare"
Moscow, Russia
Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 24 of the Moscow Department of Healthcare"
Moscow, Russia
State budgetary institution "Research Institute of Emergency Care named after N.V. Sklifosovsky in Department of Health of the city of Moscow"
Moscow, Russia
Moscow State Budgetary Healthcare Institution "City Clinical Hospital No. 40 of the Moscow Department of Healthcare"
Moscow, Russia
State budgetary institution of health care of the Nizhny Novgorod region "Infectious clinical hospital No. 2 of Nizhny Novgorod"
Nizhny Novgorod, Russia
Federal State Budgetary Educational Institution of Higher Education "Orenburg State Medical University" of the Ministry of Health of the Russian Federation
Orenburg, Russia
Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after Academician I.P. Pavlov
Saint Petersburg, Russia
...and 4 more locations